Neuralstem Showing Promise In Stem Cell Treatment Of ALS

Neuralstem Showing Promise In Stem Cell Treatment Of ALS

by Ramu Iyer

A few days ago, local Fox TV stations aired a story about a medical trial by Neuralstem (CUR), which they described as “one of the most powerful stories we’ve ever reported.” Ted Harada is the eighteenth and final patient to receive human stem cell transplant treatment for amyotrophic lateral sclerosis (ALS) patients as part of a clinical phase 1 trial being conducted at Emory. He is also one of the first patients to ever experience a partial recovery from the dreaded disease. It is also called Lou Gehrig’s disease (the famous sporting star Lou Gehrig died of the disease), and sometimes motor neuron disease, because it is a gradual degeneration of the nerves that control motor functions.  It progressively incapacitates the body’s motor functions to the point where the patient cannot breathe by himself or herself. Up until this point, it has been invariably fatal, with no current treatment or cure. A new stem cell treatment from Neuralstem could change all that.

Neuralstem announced the completion of the phase 1 trial of its NSI-566 spinal cord neural stem cells for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), with the treatment on Harada. Harada was the third patient to return for an additional set of injections, and phase 1 will conclude six months after this last treatment.  He had his first treatment seventeen months ago when stem cells were transplanted.  Soon he began to get better, and could even walk around the neighborhood with the help of a cane. But recently, the weakness started to come back and Ted volunteered for the second round of treatment.

Neuralstem found out that the fatal nerve damage caused by ALS could be slowed down, and even reversed, by supporting healthy cells in the spinal column with the integration of targeted stem cells.  The stem cells have been cultured and multiplied in their laboratories, and treatment consists of both injecting cells into the spinal cord and exposing the spinal cord to introduce the cells. The stem cells have the capability of growing into nerve cells that support the existing nerves.  You can appreciate the delicacy of the process when you understand that the spinal cord controls every breath you take and every muscle in your body. After completing preliminary studies in animals, the company received FDA approval for human treatment as well as the highly coveted orphan designation. The company developed a patented device for intra-spinal cord surgery, which was used for the stem cell treatment in the eighteen patients. Neuralstem also devised procedures to freeze and preserve the stem cells until they are used.

The purpose of the phase 1 trial was only to assess the safety of the treatment, not to prove the efficacy of benefits. The phase 1 trial commenced in January 2010. The first twelve patients received the treatment in the lumbar or lower back region of the spine.  The treatment was then advanced to the cervical or upper back region. The last three patients received treatment in both regions and the FDA approved the inclusion of previously treated patients in this last batch. The motor neurons that control breathing and the ones that patients need to survive are in the upper spinal cord, primarily in the neck. It is also important to remember that the dosages used in the trial, including the treatment of Ted Harada, were approximately one third of the dosages that will be eventually used.  The trial also meant that patients had to agree to undergo the spinal procedure and to take immuno-suppressant drugs for the rest of their lives in order to prevent rejection of the stem cells being infused.
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“There have been many firsts in this trial, including the first lumbar intraspinal injections, the first cervical region intraspinal injections, and the first cohort of patients to receive both,” commented  Jonathan D. Glass, MD, Director of the Emory ALS Center. Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System, is the principal investigator on the trial, and an unpaid consultant to Neuralstem. She noted, “We have found the procedure to be extremely safe. In some patients, it appears that the disease is no longer progressing, but it is too early to know if the result from that small number of patients is meaningful.”

Just a few days earlier, Neuralstem announced that it had received a notice of issuance for patent number 12/710,097, titled “Transplantation of Human Neural Cells for Treatment of Neurodegenerative Conditions.” This patent covers both the culturing of central nervous system cells as well as transplanting them into spinal cord tissue to treat neurodegenerative conditions including ALS. This is an important addition to its intellectual capital, because it covers every stage and facet of the treatment, and the patent is valid up to the year 2030.

In addition to ALS, the company is also targeting other major central nervous system ailments with its treatment such as spinal cord injury and ischemic spastic paraplegia, and has submitted an IND (Investigational New Drug) application to the FDA for a phase 1 safety trial in chronic spinal cord injury. The company is conducting a phase 1b to evaluate the safety of NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD).

This is a promising beginning, but there is still a long way to go before the treatment can be brought to market. This is shaping up to be a promising treatment for a disease previously considered as fatal and untreatable that is going to provide a ray of hope for many patients who may have given up on their condition altogether. While it is still too early to judge whether the treatment is going to be a blockbuster or not, the company is showing great promise. If you are interested in gaining exposure in the biotechnology sector, you should watch this stock carefully for further favorable developments.

Transparency/Disclosure: I am not a registered investment advisor and do not provide specific investment advice. The information contained herein is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research. I am a consultant to a third-party and have received two hundred fifty dollars for independent research. Always discuss investments with a licensed professional advisor before making any financial decisions. Statements made herein are often “forward-looking statements” as stipulated under Section 27A of the Securities Act of 1933, Section 21E of the Securities Act of 1934, and the Private Securities Litigation Reform Act of 1995. While I have researched this company thoroughly, my due diligence is not a substitute for your own.

Henry County man undergoes experimental ALS stem cell surgery

Henry County man undergoes experimental ALS stem cell surgery


By Beth Galvin, FOX Medical Team reporter

Read the full article Click Here

ATLANTA -A Henry County father of three has gambled on a risky, cutting-edge spinal surgery not once, but twice.

Ted Harada is the 15th and final patient to undergo a human stem cell transplant for amyotrophic lateral sclerosis (ALS) patients. He’s part of an Emory study being watched all over the world.

The surgeons aren’t just injecting cells into the spinal cord — they’re exposing the spinal cord,  It controls every breath, every movement, every muscle.

Ted and Michelle Harada have been down this road before. The two have been married 18 years. Ted, 40, was diagnosed with ALS two years ago.

“I know it’s the right thing.  And I know it’s the right thing not just because it will help me, but because there’s a lot of people out there that need help,” said Harada.

Ted knows ALS, also known as Lou Gehrig’s disease, will progressively shut down his muscles, until he can’t breathe on his own.

Ted volunteered for the first-ever human stem cell trial for ALS at Emory. He said that he’s taking the risks for his three children – a 14-year-old son, 12-year-old daughter and 8-year-old daughter.

“But that fact that it was so cutting edge of science and medicine is what appealed to me,” said Harada.

Doctors are using stem cells taken from a fetus aborted 12 years ago. They’ve been cultured and multiplied in a lab by a company called Neuralstem. They’re injecting them directly into the spinal cords of people with ALS.

Seventeen months ago, the cells transplanted into Ted’s lower spine, which controls his legs.

“Now this is a disease that doesn’t get better.  So we don’t see patients who spontaneously get better. It just doesn’t happen,” said Emory neurologist  Dr. Jonathan Glass.

But Ted did get better. Soon he could walk through his McDonough neighborhood without a cane — the one patient of 15 study volunteers to measurably get stronger.

“How could I not believe in it, when I’ve seen what it’s done, for whatever reason?  I mean, I understand it’s a safety trial, but you still can’t deny or ignore the results I’ve seen,” said Herada.

Are you 40+ and having erectile dysfunction? Are you getting low confidence while super cheap viagra http://downtownsault.org/barishs/ getting into the bed. In people with type II or III bleeding may be severe and potentially life-threatening. viagra online canadian Erectile dysfunction is viagra prices in usa an inability to sustain an erection even after being sexually aroused. There are millions of men today who suffer from this sexual dysfunction and this sildenafil generic from canada has provided them with the ultimate solution towards resolving their impotency issues. “I have difficulty explaining it —  it was unexpected,” said Glass. “It was nice to see.”

But recently the weakness has come back, So, Ted returned for one more surgery.

“I told him the risks, he knows the risks, and the risks are large,” said Glass.

“But there’s part of me that has to say, ‘Hey, it worked once, why can’t it help again,'” said Ted.

Before Ted’s second surgery began, Glass had to make sure the stem cells were still viable. To go forward, at least 70 percent have to be alive. In Ted’s case, 86.3 percent were alive.

It was neurosurgeon Nick Boulis’ 18th stem cell transplant at Emory.

“We’re going to do five injections of the cervical spinal cord,” said Boulis.

The Emory/University of Michigan team focused on the neck because the nerves there control breathing.

“Because that’s why people die.  People die of ALS because they can’t breathe,” said Glass.

Dr. Boulis and the team carefully teased open the most delicate, dangerous, real estate in the body: the cervical spinal cord. A few feet away, Dr. Glass drew the stem cells into a hair-thin tube, about 100,000 at a time.

“And then we’ll do that five times, so it will be 500,000 cells he’ll get,” said Glass.

The cells were injected into a two centimeter section of Ted’s spinal cord. The only goal of this trial  is to prove this surgery, and these cells are safe, not whether they work. But lab studies show the stem cells may help damaged or dying spinal nerve cells repair themselves.

After almost six hours in the operating room, the surgery was complete.

Nothing is promised, nothing guaranteed. But there’s hope. And for the Haradas that’s enough.

Five days out, Ted says he’s doing OK.

Now, the Emory-Michigan team will take all of its safety data to the Food and Drug Administration to ask permission to move on to the next phase of the trial. That could take about a year.

Miracle Improvement In ALS Patient Could Force Big Pharma To Get Serious On Stem Cell Therapy

Miracle Improvement In ALS Patient Could Force Big Pharma To Get Serious On Stem Cell Therapy

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Results of the study, published in April 2012, validated the safety of the procedure as none of the twelve patients’ bodies rejected the stem cells, nor was there any evidence of long-term complications. In the case of Harada, the procedure yielded positive results that allowed him to walk without a cane and helped improve his breathing. This August, Dr. Eva Feldman, a neurologist at the University of Michigan, surprisingly declared the stem cell therapy had essentially stopped the progression of the disease. The encouraging results have led to U.S. Food and Drug Administration (FDA) concurrence to inject stem cells in the cervical, or upper region, of the spinal cord.

Harada’s sudden and unexpected improvement begs several questions on the investment front; what impact will there be on the stem cell industry and will capital from major pharmaceutical companies start to flow more rapidly?

First, expect biotech companies to explore less conventional and more daring regions of the body to inject stem cells. The Neuralstem project is one of the only medical procedures that utilized the spinal cord as the entry point for stem cell injection. Second, Harada’s improvement may diminish some of the public’s aversion to stem cell treatments due to ethical concerns. The vast potential of stem cell therapies to cure humanity’s worst ailments and disorders will ease opposition to its use, creating a window that major pharmaceuticals could use to invest more resources into the industry.

Many of the major pharmaceutical companies have invested in stem cell research and biotech companies to a marginal degree. For example, Pfizer has partnered with Athersys (ATHX) to use stem cell therapy to treat inflammatory bowel disease (IBD). The drug, derived from stem cells found in bone marrow and based on Athersys’ Multistem commercial product, is currently in FDA phase 2 clinical studies. Pfizer is also working with the University College of London to develop a stem cell-based treatment for macular degeneration.

Johnson & Johnson has teamed up with Novocell, Inc to develop stem cell therapies to treat diabetes and cancer. Advanced Cell Technology (ACTC.OB) is using embryonic stem cells in an attempt to treat Stargardt’s macular dystrophy and age-related macular degeneration, two diseases that cause blindness. Neuralstem is developing stem cell treatments for strokes, Alzheimer’s, spinal cord injuries, and Parkinson’s disease. GE Healthcare (GE ) has also advanced stem cell
research through its cell technologies R&D department. Stephen Minger, the head of this department, captured the evolving stem cell industry perfectly: “When you see companies like Pfizer, GlaxoSmithKline (GSK), Johnson & Johnson, and GE invest in stem cells and regenerative medicine, it suggests a level of maturity. It is still high risk, but it is a calculated risk.”

Based on the major player’s existing involvement in stem cell research, it would not be surprising if Harada’s improvement demonstrates the technical maturity needed to push the industry to the next level. The stem cell industry certainly presents many risks; it may be very difficult to commercialize a product and caution must be given to the ethical, political, and legal concerns of stakeholders. Nonetheless, investors should watch Harada’s condition closely over the coming months and years to catch a glimpse into the future of stem cell therapy, and whether the major pharmaceutical companies finally get serious about its potential.

New Cells for ALS Patients

New Cells for ALS Patients

http://www.technologyreview.com/news/428956/new-cells-for-als-patients/

Surgeons have transplanted a second dose of neural cells into a patient’s spinal cord in a pioneering trial.

Susan Young  <http://www.technologyreview.com/contributor/susan-young/>

Thursday, August 23,

Brave attempt: Neurosurgeons at Emory University deliver a second dose of neural cells into the spinal cord of an ALS patient.
Kerry Ludlam, Emory University

This week, surgeons at Emory University in Atlanta implanted a second dose of neural cells into a patient’s spinal cord, part of an experimental treatment aimed at slowing the progression of ALS, or Lou Gehrig’s disease.

The patient, Ted Harada
<http://www.ajc.com/opinion/give-hope-to-those-1431799.html> , is the third person this summer to receive a second dose as part of the trial. The cells are produced by a Rockland, Maryland-based company called Neuralstem <http://www.neuralstem.com/>  that isolates stem cells from the brain and spinal cord of aborted fetuses. The company is also targeting other major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia, chronic stroke, and brain cancer.
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ALS gradually destroys the connections between the spinal cord and motor neurons, eventually robbing patients of all ability to move. The hope is that the cells injected into the spinal cord will provide support, perhaps by releasing growth factors, and prevent motor neurons from dying. “They nurture the dying motor neurons back to health or make them healthier and slow down the degenerative process,” says Richard Garr, CEO of Neuralstem.

“We have found that the procedure is extremely safe,” says Eva Feldman <http://www.umich.edu/%7Eneurosci/faculty/efeldman.htm> , a neurologist at the University of Michigan and the lead investigator of the trial. “In a subset of patients, we seem to see that the disease is no longer progressing,” but it is too early to know if the result from that small number of patients is meaningful, she says.

In his first surgery, Harada received 10 injections, each containing about 100,000 cells, on the sides of his lower spinal cord. After the procedure, he was able to move his limbs with strength and dexterity that surpassed his abilities before the treatment. While some ALS patients may see brief periods of small improvements or stabilization, this degree of recovery is unheard of. In the last few months, Harada says his abilities have slowly been regressing, although at a slower pace than before the treatment.

In this week’s procedure, instead of injecting cells into Harada’s lower
spine, a surgeon will place the cells into his upper spinal cord, a region that holds the large nerve cells that control breathing. Since ALS patients usually die of respiratory arrest, the researchers hope the treatment will protect motor neurons in the upper spinal cord and prevent or slow the loss of lung function.

Neuralstem’s cells are somewhat different than typical stem cells, in that they have a defined fate. By taking cells from a fetus of a particular gestation stage, the company generates cells that are still able to divide but turn into a specific cell type, such as a spinal cord cells. This unique property of Neuralstem’s cells enables the company to test potential drugs in specific central nervous system cell types in culture dishes. The company is currently searching for drugs that can protect and nurture neurons from the hippocampus, a part of the brain critical for forming and storing memories.

Another ALS trial, under way at the Mayo Clinic, is testing a  treatment that injects a patient’s own stem cells, isolated from fat tissue, into his or her spinal fluid. So far, two patients have undergone the procedure. Like the Emory trial, the Mayo Clinic study
<http://clinicaltrials.gov/ct2/show/NCT01609283?term=NCT01609283&rank=1>  is focused on safety. Although such stem cell treatments are still quite new and carry risks, the dire situation of ALS patients shifts the balance of risk and benefit. “When you have a disease like ALS, where the average survival is two to three years after diagnosis and it is uniformly fatal, investigators and the FDA think it’s ethical to try these more desperate approaches that carry potentially higher risk,” says Anthony Windebank <http://mayoresearch.mayo.edu/mayo/research/staff/windebank_aj.cfm> , a neurologist who heads the Mayo trial.

If the procedure proves safe, one of the next steps for the field would be to genetically modify the cells to produce specific growth factors likely to prevent motor neuron death, says Windebank. “If there’s any sign of efficacy with these approaches, then translation into the clinic would happen very rapidly.”

Landmark Surgery for ALS Patient Ted Harada Set for Today

http://www.benzinga.com/news/12/08/2851094/landmark-surgery-for-als-patient-ted-harada-set-for-today

Landmark Surgery for ALS Patient Ted Harada Set for Today

Louis Bedigian , Benzinga
Staff Writer

When NeuralStem (NYSE: CUR) announced that it had been successful in reversing the progression of ALS in 39-year-old Ted Harada, many wondered if researchers were finally on the cusp of a cure. Gizmodo chronicled the impressive story of the man, who showed signs of recovery last year after receiving an experimental stem cell.

Harada is scheduled to receive one final surgery in Atlanta today at the Emory University Hospital in Atlanta. This is the final part of an 18-patient Phase 1b trial. If all goes well, the study will advance to Phase 2.
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In April, Eva Feldman (the principal investigator for the trial; she is also the director of the A. Alfred Taubman Medical Research Institute and the U-M Health System’s ALS Clinic) said that the study, “reinforces our belief that we have demonstrated a safe, reproducible and robust route of administration into the spine for these spinal cord neural stem cells.”

“The publication covers data up to 18 months out from the original
surgery,” she said in a press release regarding the research. “However, we must be cautious in interpreting this data, as this trial was neither designed nor statistically powered to study efficacy.”

National news media outlets, including FOX and MSNBC, have been covering the study and the progress that Harada — who has reportedly become somewhat of a celebrity in Atlanta and within the medical community — has been making.

During the Phase 1b portion of the trial, NeuralStem’s primary goal is to prove that it is safe to inject stem cells into the spinal cord. If this
proves to be safe, more human patients will be enrolled in the next phase.

Cutting-edge clinical trial offers hope to those with ALS

http://www.usatoday.com/news/health/story/2012-08-05/clinical-trial-fights-ALS/56791326/1

  • Regis Kleiss, 28, of Royal Oak, Mich., is taking part in a clinical trial to combat amyotrophic lateral sclerosis, led by the University of Michigan.
  • By Kimberly P. Mitchell, Detroit Free PressRegis Kleiss, 28, of Royal Oak, Mich., is taking part in a clinical trial to combat amyotrophic lateral sclerosis, led by the University of Michigan.

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DETROIT – Sometimes she glares at the painting of Jesus in her dining room.

“I just let it loose,” said Mary Kleiss at her Royal Oakhome. “I look at that picture and I say, ‘You get down here and put on your boxing gloves and let’s get this over with.’ I am so damned angry.”

Her son, Regis, was diagnosed 2½ years ago with Lou Gehrig‘s disease, formally known as amyotrophic lateral sclerosis, or ALS. It is, he writes, “as if God is torturing me.”

The disease kills with swift and stunning efficiency — deadening its victims’ peripheral nerves, withering muscles and, in a final assault, shutting down their ability to breathe. An estimated 30,000 people have the disease at any given time; 5,000 are diagnosed yearly. Most die within a few years. There is no cure.

The disease has reduced Regis Kleiss, 28, a formerly thick-bodied shot and discus thrower and captain of the high school track team, to a bony echo of himself.

Paralyzed except for some minor movement he can make with his head, he will spend his final days on a feeding tube, unable to hold his bassett hound, Riley, or hug his parents or his niece or even scratch his head. And the cruelest thing of all? ALS leaves its victims’ minds intact.

“It’s a miserable, damned disease,” his mother said.

Now, a clinical trial overseen by the University of Michigan may provide hope. It’s tentative and early. But when the rest of a person’s life has been compressed to an expectancy of two to five years, it is hope, nonetheless.

The trial has been based in Atlanta since 2010, but Michigan has requested approval from the U.S. Food and Drug Administration to expand it and move it to Ann Arbor. It is cutting-edge and audacious work — the only ALS trial so far in which neural stem cells are injected directly into a patient’s spinal cord. So far, 15 patients have undergone the procedure — two of them twice — as the FDA monitors its safety.

One patient showed a remarkable improvement, though Michigan’s Dr. Eva Feldman, who heads the research, cautions not to read too much into that.

The trial involves injecting 500,000 to 1 million stem cells into the spine. The ancestry of the line of cells dates to the spinal cord of an aborted fetus in 2000.

Feldman and others theorize that these new cells act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The procedure worked in rats. It has been shown to be safe in pigs.

If the FDA approves the expansion of the human trial, patients will have access to an experimental treatment that not only might offer insight into a disease that kills an estimated 15 Americans a day, but also push back the battle lines against other neurodegenerative diseases, such as Parkinson’s, Alzheimer’s or Huntington’s.

Last month, Feldman flew down with a team of Michigan staff for the 17th surgery in the trial, in anticipation that the trial might soon move to Ann Arbor. The trial has been at Emory University in Atlanta since it began.

Feldman is clear and she repeats this often: This part of the trial tests safety only. By design, it doesn’t assess the efficacy of the treatment yet.

So the clinical trial patients so far — all from the Atlanta area — know the experimental stem cell therapy probably will not cure them. Still, they’re empowered, knowing their participation might one day cure others, said Ed Tessaro, a retired Macy’s executive.

The following morning, Tessaro, 66, lay on an operating room table at Emory’s hospital, as doctors removed part of the bone in his spine and laid bare a pulsating, bright-white spinal cord for a second infusion of stem cells.

“It may kill us,” Tessaro said of the disease, “but it’s not going to defeat us before we die.”

‘The worst thing I could tell you’

It was 2008 when a single misstep and near-stumble during a half-marathon in Bangkok, Thailand, first worried Tessaro. It happened more than once. His muscles weakened, even as he stepped up his time at the gym.

Months later, a doctor delivered the news to him and his wife, Judy.

“She said, ‘It’s the worst thing I could tell you,'” Judy Tessaro recalled.

“‘You have ALS, and you have two to four years to live,'” Ed Tessaro added.

Tessaro took stock. Life had been good, he decided.

Tessaro has been married for 43 years. He has a daughter and son, and is a grandfather to two little girls.

Now, every conversation, every gentle touch from his wife, the babbling of his grandbabies — his senses are in now in hyperdrive.

“In retrospect, I was living in analog. What I’m now living my life in is high-definition. I’m living my life fully, because I know I have less of it,” Tessaro said.

When he heard about the clinical trial, Tessaro jumped at it.

“It’s not like I can hope for a miraculous reversal of this disease — it’s not coming,” he said. “I don’t think I have anything to lose and I can be part of something bigger. It’s great therapy when you commit yourself to something bigger.”

He became Patient No. 12 on April 13. Doctors slipped stem cells into the lower — or lumbar — section of his spine. The area that controls lower body movement, it was considered least risky because Tessaro was already losing the strength in his legs anyway.

Tessaro survived. In fact, he left the hospital days earlier than expected and felt better sooner than he expected.

So doctors decided — and the FDA approved — a second, riskier, surgery for Tessaro. This time, doctors would move to the upper — or cervical — portion of Tessaro’s spine, the area in which the nerves are responsible for breathing.

Feldman calls this area “precious real estate,” the stretch of spine where researchers say they believe the treatment may be most effective.

“Higher risk, but maybe higher reward,” Tessaro said, shrugging. He was in the pre-operating room of Emory University Hospital, surrounded by family and overnight bags and medical tubes and equipment.

It was July 20.

In a stretch of hallway and an elevator ride away, a nondescript FedEx box was being delivered to Dr. Jonathan Glass, director of the ALS clinic at Emory. His hands were working quickly.

An unexpected result

Ted Harada is on Page 8 of the March Journal of Stem Cells, which published the first study announcing the preliminary results of the first 12 patients.

Harada is the anomaly. Like Tessaro did last month, Harada this month will undergo a second surgery. And like with Tessaro, it took some time to diagnose the mysterious weakening of Harada’s body.

The former FedEx managing director, now 40, noticed he was getting winded in 2009 while playing Marco Polo in the family pool with his three children: “I’d go under water and come back up, and I was sucking for air.”

After a string of doctors — a family doctor, an orthopedist, a neurologist — the final diagnosis came in August 2010: ALS. The diagnosis was devastating, but the timing couldn’t have been better, the neurologist told him.

By the time Harada went in for his surgery in March 2011, he was using a cane, unable to walk to the end of the driveway for the mail without losing his breath or to climb the 15 stairs to tuck his children in at night.

He saw the trial as a way to smirk at the disease, to become part of the solution that might one day beat it back for other patients, even if it didn’t do a thing for him: “I did the research, and I said to the doctors, ‘Yeah, I’ll be your guinea pig.'”

But what happened after his surgery no one had expected.

The 14 other patients involved in the trial to date have shown no improvement; four have died — three from complications of ALS, and the other from a heart-related issue, according to Neuralstem.

In contrast, Harada put aside his cane soon after the surgery. And he was again tucking his children into their beds.

Feldman is insistent: Don’t read too much into Harada’s turnaround. The number of patients is tiny, and Ted is an oddity among them.

Still, Harada’s improvement, even if temporary, can’t be ignored.

The researchers have used several tests to measure patients’ outcomes, such as breathing capacity, the strength of their handgrip, and even the electrical impulses that flow through their muscles. There on these graphs is Harada, his dotted lines suddenly shooting upward after surgery.

In designing the clinical trial, “we were only aiming at stopping the disease,” said Dr. Karl Johe, chairman and chief scientific officer of Neuralstem. “But this is a patient that has clearly improved.”

Recently, Harada has begun to get winded again climbing the steps to his children’s bedrooms. He and wife, Michelle, 39, a sixth-grade teacher, have explained to their children that he probably won’t get better this time.

A six-hour procedure

Ed Tessaro was facedown, mostly draped in surgery blue in the crowded Emory operating room. It was 12:23 p.m. on July 20.

A stainless steel, crane-like contraption had been screwed into the cervical section of his spine. A steady beep-beep-beep of the monitors punctuated the hiss of a respirator. A digital camera recorded every movement for the FDA.

Standing just a few feet from Dr. Nicholas Boulis, who collaborated with Feldman on her research for seven years during his residency, Glass was ready with the spinal cord exposed.

It was 2:34 p.m. when Boulis asked for the cells.

For the next half hour, the vials were readied for the patented apparatus, on which an injection device slid along a guide to Tessaro’s spinal cord. It would inject 100,000 cells for each of five stops precisely 4 millimeters apart.

The target was the ventral horn of the spinal cord, a tiny area associated with motor neurons.

At 3:06 p.m., the injection device slid into place. A needle extended, injecting deep into the spinal cord and, for two minutes, the stem cells were forced into the ventral horn.

At 3:29 p.m., the fifth and final injection began, and two minutes later, the relief was palpable. From her viewing spot just a few yards from Tessaro’s neck, Feldman shifted on her feet and exhaled. The procedure, from start to finish, took a little more than six hours.

Technicians began to check recordings and run over the notes for the FDA. Boulis and the others began the process of removing the device and closing in the gaping hole in Tessaro’s back.

Feldman transferred the digital recording of the process to a memory stick she could review back at the office. A copy would go to the FDA, too.

There will be many more months of data, continued animal tests and most likely, hundreds of pages of reports.

Even if this early stage is proved safe and the clinical trial continues, doctors must figure out whether these are the stem cells that work best in this therapy, and, if so, in what amounts and injected into which areas. There’s the issue of the patients’ bodies rejecting these foreign bodies, too.

“This is not a small molecule pill, and your patients go home and take the pill and you see them in your clinic in a few months,” said Steve Perrin, CEO of ALS Therapy Development Institute, a Massachusetts-based nonprofit focused on finding a treatment or cure for ALS. “These are the challenges this trial and this technology have in front of (them). They’re paving the road, because no one has been down this way before.”

Friday, Tessaro was recuperating well at his home.

Regis Kleiss, 28, of Royal Oak, Mich., is taking part in a clinical trial to combat amyotrophic lateral sclerosis, led by the University of Michigan.

By Kimberly P. Mitchell, Detroit Free Press

DETROIT – Sometimes she glares at the painting of Jesus in her dining room.

“I just let it loose,” said Mary Kleiss at her Royal Oak home. “I look at that picture and I say, ‘You get down here and put on your boxing gloves and let’s get this over with.’ I am so damned angry.”

Her son, Regis, was diagnosed 2½ years ago with Lou Gehrig’s disease, formally known as amyotrophic lateral sclerosis, or ALS. It is, he writes, “as if God is torturing me.”

The disease kills with swift and stunning efficiency — deadening its victims’ peripheral nerves, withering muscles and, in a final assault, shutting down their ability to breathe. An estimated 30,000 people have the disease at any given time; 5,000 are diagnosed yearly. Most die within a few years. There is no cure.

The disease has reduced Regis Kleiss, 28, a formerly thick-bodied shot and discus thrower and captain of the high school track team, to a bony echo of himself.

Paralyzed except for some minor movement he can make with his head, he will spend his final days on a feeding tube, unable to hold his bassett hound, Riley, or hug his parents or his niece or even scratch his head. And the cruelest thing of all? ALS leaves its victims’ minds intact.

“It’s a miserable, damned disease,” his mother said.

Now, a clinical trial overseen by the University of Michigan may provide hope. It’s tentative and early. But when the rest of a person’s life has been compressed to an expectancy of two to five years, it is hope, nonetheless.

The trial has been based in Atlanta since 2010, but Michigan has requested approval from the U.S. Food and Drug Administration to expand it and move it to Ann Arbor. It is cutting-edge and audacious work — the only ALS trial so far in which neural stem cells are injected directly into a patient’s spinal cord. So far, 15 patients have undergone the procedure — two of them twice — as the FDA monitors its safety.

One patient showed a remarkable improvement, though Michigan’s Dr. Eva Feldman, who heads the research, cautions not to read too much into that.

The trial involves injecting 500,000 to 1 million stem cells into the spine. The ancestry of the line of cells dates to the spinal cord of an aborted fetus in 2000.

Feldman and others theorize that these new cells act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The procedure worked in rats. It has been shown to be safe in pigs.

If the FDA approves the expansion of the human trial, patients will have access to an experimental treatment that not only might offer insight into a disease that kills an estimated 15 Americans a day, but also push back the battle lines against other neurodegenerative diseases, such as Parkinson’s, Alzheimer’s or Huntington’s.

Last month, Feldman flew down with a team of Michigan staff for the 17th surgery in the trial, in anticipation that the trial might soon move to Ann Arbor. The trial has been at Emory University in Atlanta since it began.

Feldman is clear and she repeats this often: This part of the trial tests safety only. By design, it doesn’t assess the efficacy of the treatment yet.

So the clinical trial patients so far — all from the Atlanta area — know the experimental stem cell therapy probably will not cure them. Still, they’re empowered, knowing their participation might one day cure others, said Ed Tessaro, a retired Macy’s executive.

The following morning, Tessaro, 66, lay on an operating room table at Emory’s hospital, as doctors removed part of the bone in his spine and laid bare a pulsating, bright-white spinal cord for a second infusion of stem cells.

“It may kill us,” Tessaro said of the disease, “but it’s not going to defeat us before we die.”

‘The worst thing I could tell you’

It was 2008 when a single misstep and near-stumble during a half-marathon in Bangkok, Thailand, first worried Tessaro. It happened more than once. His muscles weakened, even as he stepped up his time at the gym.

Months later, a doctor delivered the news to him and his wife, Judy.

“She said, ‘It’s the worst thing I could tell you,'” Judy Tessaro recalled.

“‘You have ALS, and you have two to four years to live,'” Ed Tessaro added.

Tessaro took stock. Life had been good, he decided.

Tessaro has been married for 43 years. He has a daughter and son, and is a grandfather to two little girls.

Now, every conversation, every gentle touch from his wife, the babbling of his grandbabies — his senses are in now in hyperdrive.

“In retrospect, I was living in analog. What I’m now living my life in is high-definition. I’m living my life fully, because I know I have less of it,” Tessaro said.

When he heard about the clinical trial, Tessaro jumped at it.

“It’s not like I can hope for a miraculous reversal of this disease — it’s not coming,” he said. “I don’t think I have anything to lose and I can be part of something bigger. It’s great therapy when you commit yourself to something bigger.”

He became Patient No. 12 on April 13. Doctors slipped stem cells into the lower — or lumbar — section of his spine. The area that controls lower body movement, it was considered least risky because Tessaro was already losing the strength in his legs anyway.

Tessaro survived. In fact, he left the hospital days earlier than expected and felt better sooner than he expected.

So doctors decided — and the FDA approved — a second, riskier, surgery for Tessaro. This time, doctors would move to the upper — or cervical — portion of Tessaro’s spine, the area in which the nerves are responsible for breathing.

Feldman calls this area “precious real estate,” the stretch of spine where researchers say they believe the treatment may be most effective.

“Higher risk, but maybe higher reward,” Tessaro said, shrugging. He was in the pre-operating room of Emory University Hospital, surrounded by family and overnight bags and medical tubes and equipment.

It was July 20.

In a stretch of hallway and an elevator ride away, a nondescript FedEx box was being delivered to Dr. Jonathan Glass, director of the ALS clinic at Emory. His hands were working quickly.

An unexpected result

Ted Harada is on Page 8 of the March Journal of Stem Cells, which published the first study announcing the preliminary results of the first 12 patients.

Harada is the anomaly. Like Tessaro did last month, Harada this month will undergo a second surgery. And like with Tessaro, it took some time to diagnose the mysterious weakening of Harada’s body.

The former FedEx managing director, now 40, noticed he was getting winded in 2009 while playing Marco Polo in the family pool with his three children: “I’d go under water and come back up, and I was sucking for air.”

After a string of doctors — a family doctor, an orthopedist, a neurologist — the final diagnosis came in August 2010: ALS. The diagnosis was devastating, but the timing couldn’t have been better, the neurologist told him.

By the time Harada went in for his surgery in March 2011, he was using a cane, unable to walk to the end of the driveway for the mail without losing his breath or to climb the 15 stairs to tuck his children in at night.

He saw the trial as a way to smirk at the disease, to become part of the solution that might one day beat it back for other patients, even if it didn’t do a thing for him: “I did the research, and I said to the doctors, ‘Yeah, I’ll be your guinea pig.'”

But what happened after his surgery no one had expected.

The 14 other patients involved in the trial to date have shown no improvement; four have died — three from complications of ALS, and the other from a heart-related issue, according to Neuralstem.

In contrast, Harada put aside his cane soon after the surgery. And he was again tucking his children into their beds.

Feldman is insistent: Don’t read too much into Harada’s turnaround. The number of patients is tiny, and Ted is an oddity among them.

Still, Harada’s improvement, even if temporary, can’t be ignored.

The researchers have used several tests to measure patients’ outcomes, such as breathing capacity, the strength of their handgrip, and even the electrical impulses that flow through their muscles. There on these graphs is Harada, his dotted lines suddenly shooting upward after surgery.

In designing the clinical trial, “we were only aiming at stopping the disease,” said Dr. Karl Johe, chairman and chief scientific officer of Neuralstem. “But this is a patient that has clearly improved.”

Recently, Harada has begun to get winded again climbing the steps to his children’s bedrooms. He and wife, Michelle, 39, a sixth-grade teacher, have explained to their children that he probably won’t get better this time.

A six-hour procedure

Ed Tessaro was facedown, mostly draped in surgery blue in the crowded Emory operating room. It was 12:23 p.m. on July 20.

A stainless steel, crane-like contraption had been screwed into the cervical section of his spine. A steady beep-beep-beep of the monitors punctuated the hiss of a respirator. A digital camera recorded every movement for the FDA.

Standing just a few feet from Dr. Nicholas Boulis, who collaborated with Feldman on her research for seven years during his residency, Glass was ready with the spinal cord exposed.

It was 2:34 p.m. when Boulis asked for the cells.

For the next half hour, the vials were readied for the patented apparatus, on which an injection device slid along a guide to Tessaro’s spinal cord. It would inject 100,000 cells for each of five stops precisely 4 millimeters apart.

The target was the ventral horn of the spinal cord, a tiny area associated with motor neurons.

At 3:06 p.m., the injection device slid into place. A needle extended, injecting deep into the spinal cord and, for two minutes, the stem cells were forced into the ventral horn.

At 3:29 p.m., the fifth and final injection began, and two minutes later, the relief was palpable. From her viewing spot just a few yards from Tessaro’s neck, Feldman shifted on her feet and exhaled. The procedure, from start to finish, took a little more than six hours.

Technicians began to check recordings and run over the notes for the FDA. Boulis and the others began the process of removing the device and closing in the gaping hole in Tessaro’s back.

Feldman transferred the digital recording of the process to a memory stick she could review back at the office. A copy would go to the FDA, too.

There will be many more months of data, continued animal tests and most likely, hundreds of pages of reports.

Even if this early stage is proved safe and the clinical trial continues, doctors must figure out whether these are the stem cells that work best in this therapy, and, if so, in what amounts and injected into which areas. There’s the issue of the patients’ bodies rejecting these foreign bodies, too.

“This is not a small molecule pill, and your patients go home and take the pill and you see them in your clinic in a few months,” said Steve Perrin, CEO of ALS Therapy Development Institute, a Massachusetts-based nonprofit focused on finding a treatment or cure for ALS. “These are the challenges this trial and this technology have in front of (them). They’re paving the road, because no one has been down this way before.”

Friday, Tessaro was recuperating well at his home.

ALS Living with Mortality

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ALS strikes at random, killing young and old

By Robin Erb
Detroit Free Press Medical Writer

To Read The Full Article Click Here

Sometimes she glares at the painting of Jesus in her dining room.

“I just let it loose,” said Mary Kleiss at her Royal Oak home. “I look at that picture and I say, ‘You get down here and put on your boxing gloves and let’s get this over with.’ I am so damned angry.”

Her son, Regis, was diagnosed two and a half years ago with Lou Gehrig’s disease — amyotrophic lateral sclerosis, or ALS. It is, he writes, “as if God is torturing me.”

The disease kills with stunning efficiency — deadening its victims’ peripheral nerves, withering muscles and, in a final assault, shutting down their ability to breathe. An estimated 30,000 people have it at any given time; 5,000 are diagnosed yearly. Most die within years. There is no cure.

The disease has reduced Regis Kleiss, 28, a formerly thick-bodied shot and discus thrower and captain of the track team at Dondero High School, to a bony echo of himself. Paralyzed except for some minor movement of his head, he will spend his final days on a feeding tube.

ALS leaves its victims’ minds intact.

“It’s a miserable, damned disease,” his mother said.

Now, a clinical trial overseen by the University of Michigan may provide hope. It is cutting-edge and audacious work — the only ALS trial so far in which neural stem cells are injected directly into a patient’s spinal cord. So far, 15 patients have undergone the procedure — two of them twice — as the FDA monitors its safety.

One patient showed a remarkable improvement for a while, though U-M’s Dr. Eva Feldman, who heads the research, cautions not to read too much into that. The other 14 showed no improvement.

The trail is tentative and early. But when the rest of a person’s life has been compressed to an expectancy of two to five years, it is hope nonetheless.

The trial has been based in Atlanta since 2010, but U-M has requested approval from the U.S. Food and Drug Administration to expand it and move it to the University of Michigan in Ann Arbor.

The trial involves injecting 500,000-1 million stem cells into the spine. The ancestry of the cells dates to the spinal cord of an aborted fetus in 2000. The cells are different from the embryonic stem cells that were the subject of a controversial ballot proposal in Michigan in 2008, when voters approved lifting the ban on embryonic stem cell research.

Feldman and others theorize that these new cells act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The procedure worked in rats. It has been shown to be safe in pigs.

If the FDA approves moving the trial to Ann Arbor, Michigan patients will have access to an experimental treatment that not only might offer insight into a disease that kills an estimated 15 Americans a day, but also push back the battle lines against other neurodegenerative diseases, such as Parkinson’s and Alzheimer’s or Huntington’s.

“There is a lot of potential here,” said Sue Burstein-Kahn, executive director of ALS of Michigan, a Southfield-based nonprofit.

Last month, Feldman flew down with a team of U-M staff for the 17th surgery in the trial, in anticipation that the trial might soon move to Ann Arbor. The trial has been at Emory University in Atlanta since it began, in part, because Feldman wanted a former U-M neurosurgery resident, Dr. Nicholas Boulis, who is now at Emory, to perform the delicate procedure. Boulis collaborated with Feldman on her research for seven years during his residency.

Feldman is clear and she repeats this often: This part of the trial tests safety only. By design, it doesn’t
assess the efficacy of the treatment yet.

So the clinical trial patients so far — all from the Atlanta area — know the experimental stem cell therapy probably will not cure them. Still, they’re empowered, knowing their participation might one day cure others, said Ed Tessaro, a retired Macy’s executive, from his home overlooking a sparkling Georgian lake.

The following morning, Tessaro, 66, lay on an operating room table at Emory’s hospital, as doctors sliced through his skin and muscle, removed part of the bone in his spine and laid bare a pulsating, bright-white spinal cord for a second infusion of stem cells.

“It may kill us,” Tessaro said of the disease, “but it’s not going to defeat us before we die.”
Serving a greater purpose

It was 2008 when a single misstep and near-stumble during a half-marathon in Bangkok, Thailand, first worried Tessaro. It happened more than once. His muscles weakened, even as he stepped up his time at the gym.

Months later, a fresh, young doctor delivered the news to him and his wife, Judy.

They remember it well, even now.

“She said, ‘It’s the worst thing I could tell you,’ ” Judy Tessaro recalled.

” ‘You have ALS, and you have two to four years to live,’ ” Ed Tessaro added.

The doctor cried that day. So did Judy and Ed.

“The dynamics are pretty grim — fatal, no cure. Nobody has ever been cured. … It takes a while to get your head wrapped around that kind of reality,” Ed Tessaro said.

But Tessaro took stock. Life had been good, he decided.

Tessaro has been married for 43 years. He has a daughter and son and is a grandfather to two little girls. When he speaks of them, he can’t help but grin. And the pictures in the downstairs rec room at the Tessaros’ home are of a thrill-filled life: ice-climbing in New Zealand, marveling at the lush green of Vietnamese rice paddies, being stunned by the chase-and-dart flurry of a cheetah taking down a Thomson’s gazelle in the Serengeti.

Hiking. Biking. Skydiving.

He thought life couldn’t be more vivid. He was wrong.

Now, every conversation, every gentle touch from his wife, the babbling of his grandbabies — his senses are now in hyperdrive.

“In retrospect, I was living in analog. What I’m now living my life in is high-definition. … I’m living my life fully, because I know I have less of it,” Tessaro said.

When he heard about the clinical trial, Tessaro jumped at it, calling it “the larger-purpose stuff.”

“It’s not like I can hope for a miraculous reversal of this disease — it’s not coming,” he said. “I don’t think I have anything to lose … and I can be part of something bigger. It’s great therapy when you commit yourself to something bigger.”

He became Patient No.12 on April 13. Doctors slipped stem cells into the lower — or lumbar — section of his spine. The area that controls lower body movement, it was considered least risky because Tessaro was already losing the strength in his legs anyway. Clinical trial protocol limits risk.

Tessaro survived. In fact, he left the hospital days earlier than expected and felt better sooner than he expected.

So doctors decided — and the FDA approved — a second, riskier, surgery for Tessaro. This time, doctors would move to the upper — or cervical — portion of Tessaro’s spine, the area in which the nerves are responsible for breathing.

Feldman calls this area “precious real estate,” the stretch of spine where researchers say they believe the treatment may be most effective.

“Higher risk, but maybe higher reward,” Tessaro said, shrugging. He was in the pre-operating room of Emory University Hospital, surrounded by family and overnight bags and medical tubes and equipment.

It was July 20.

In a stretch of hallway and an elevator ride away, a nondescript FedEx box was being delivered to Dr. Jonathan Glass, director of the ALS clinic at Emory. His hands were working quickly.
Preparing for surgery

Glass pulled from the temperature-controlled container several vials of the stem cells known as NSI-566RSC. They had been thawed to about 39 degrees and then shipped overnight to Emory by Neuralstem, a Rockville, Md.-based biomedical company that is funding the trial, according to CEO and President Richard Garr.

The company has shelled out about $2.5 million for the first phase of the trial and provided the stem cells, one of the company’s premier products. They were drawn and cultured from the spine of an aborted fetus in 2000, then cultured again. They remain frozen until the day before they are ready for use.

They have arrived at Emory at 8 a.m. each surgery day of this trial — “never been late,” said Jane Bordeau, a research nurse and coordinator for the trial at Emory.

Glass separated out some of the liquid to test in separate vials, slipping some drops of blue liquid into the vials and tapping them lightly with a middle finger. He slid them onto a slide and rolled his chair to a microscope.

Dead cells will glow blue, he explained, having absorbed a dye that seeps inside their degrading membranes. Live cells remain clear and bright. At least 70% must be alive to be considered viable and to begin surgery, according to Neuralstem.

Glass began counting.

In an upstairs operating room, a red second hand circled a wall clock.

In the pre-op room, Tessaro had been discussing the 25 videos he planned to make for his toddler-age grandchildren. He knows ALS will steal his voice. So he will travel to the Smoky Mountains, set up a tripod and record for them stories, like how he met their grandmother.

He talked about the two books in his overnight bags, too: Hemingway’s “Farewell to Arms,” and — he added, laughing — “Fifty Shades of Grey,” because his daughter dared him.

Nearby, his wife was quiet. She fidgeted with an overnight bag.

In his lab, Glass punched some buttons on his cell phone calculator.

“It’s cool,” he announced. By his calculations, 83.6% of the cells had arrived alive.

It was time. The surgery would go as planned.
Surprising the doctors
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Ted Harada is on Page 8 of the March Journal of Stem Cells, which published the first study announcing the preliminary results of the first 12 patients.

Harada is the anomaly. Patient No. 11. Like Tessaro did last month, Harada this month will undergo a second surgery. And like with Tessaro, it took some time to diagnose the mysterious weakening of Harada’s body.

The former FedEx managing director, now 40, noticed he was getting winded in 2009 while playing Marco Polo in the family pool with his three children: “I’d go under water and come back up, and I was sucking for air.”

After a string of doctors — a family doctor, an orthopedist, a neurologist — the final diagnosis came in August 2010: ALS. The diagnosis was devastating, but the timing couldn’t have been better, the neurologist told him.

Clinical trial #NCT01348451 was under way.

By the time Harada, a self-described type A personality, went in for his surgery in March 2011, he was using a cane, unable to walk to the end of the driveway for the mail without losing his breath or to climb the 15 stairs to tuck his children in at night.

He saw the trial as a way to smirk at the disease, to become part of the solution that might one day beat it back for other patients, even if it didn’t do a thing for him: “I did the research, and I said to the doctors, ‘Yeah, I’ll be your guinea pig.’ ”

To his way of thinking, someone had to be the first man on the moon. Someone has to step up for medical research.

Plus, he added, “I know how the book ends if I do nothing.”

But what happened after his surgery wrote a chapter no one had expected.

The 14 other patients involved in the trial to date have shown no improvement; four have died — three from complications of ALS, and the other from a heart-related issue, according to Neuralstem.

In contrast, Harada put aside his cane soon after the surgery. And he was again tucking his children into their beds.

Feldman is insistent: Don’t read too much into Harada’s turnaround. The number of patients is tiny, and Ted is an oddity among them.

Still, Harada’s improvement, even if temporary, can’t be ignored.

The researchers have used several tests to measure patients’ outcomes, such as breathing capacity, the strength of their handgrip, and even the electrical impulses that flow through their muscles. There on these graphs is Harada, his dotted lines suddenly shooting upward after surgery.

In designing the clinical trial, “we were only aiming at stopping the disease,” said Dr. Karl Johe, chairman and chief scientific officer of Neuralstem. “But this is a patient that has clearly improved.”

Recently, Harada has begun to get winded again climbing the steps to his children’s bedrooms. He and wife, Michelle, 39, a sixth-grade teacher, have explained to their children that he probably won’t get better this time.

In her worst moments, Michelle has foreseen graduations and Christmases and grandchildren without him.

In their kitchen, the Haradas’ children had just finished slathering peanut butter on bread and disappeared upstairs. A deeply religious couple, the Haradas said they’ll take what they can get.

“We’ve been blessed,” he said.

Michelle Harada agreed, struggling against a surge of tears: “The surgery gave us two years back.”
Paving the way for others

Ed Tessaro was facedown, mostly draped in surgery blue in the crowded Emory operating room . It was 12:23 p.m. on July 20.

A stainless steel, crane-like contraption had been screwed into the cervical section of his spine. A steady beep-beep-beep of the monitors punctuated the hiss of a respirator. A digital camera recorded every movement for the FDA.

Standing just a few feet from Boulis, Glass was ready, with the spinal cord exposed.

It was 2:34 p.m. when Boulis asked for the cells.

For the next half hour, the vials were readied for the patented apparatus, on which an injection device slid along a guide to Tessaro’s spinal cord. It would inject 100,000 cells for each of five stops precisely 4 millimeters apart.

The target was the ventral horn of the spinal cord, a tiny area associated with motor neurons.

“Just looking at the spine can hurt it,” Glass had said earlier.

At 3:06 p.m., the injection device slid into place. A needle extended, injecting deep into the spinal cord and, for two minutes, the stem cells were forced into the ventral horn.

At 3:29 p.m., the fifth and final injection began, and two minutes later, the relief was palpable. From her viewing spot just a few yards from Tessaro’s neck, Feldman shifted on her feet and exhaled. The procedure, from start to finish, took a little more than six hours.

Technicians began to check recordings and run over the notes for the FDA. Boulis and the others began the process of removing the device and closing in the gaping hole in Tessaro’s back.

“Can we get some music in here?” Boulis said.

Whiz Khalifa’s rap filled the OR.

Feldman transferred the digital recording of the process to a memory stick she could review back at the office. A copy would go to the FDA, too.

There will be many more months of data, continued animal tests and most likely, hundreds of pages of reports.

Even if this early stage is proved safe and the clinical trial continues, doctors must figure out whether these are the stem cells that work best in this therapy, and, if so, in what amounts and injected into which areas. There’s the issue of the patients’ bodies rejecting these foreign bodies, too.

“This is not a small molecule pill, and your patients go … home and take the pill and you see them in your clinic in a few months,” said Steve Perrin, CEO of ALS Therapy Development Institute, a Massachusetts-based nonprofit focused on finding a treatment or cure for ALS. “These are the challenges this trial and this technology have in front of (them). They’re paving the road, because no one has been down this way before.”

On Friday, Tessaro was recuperating at home.
Waiting for any good news

In the Kleiss’ Royal Oak home these days, Riley the bassett hound has learned that her owner’s lap is no longer hers.

The Kleisses continue to wait for any news they can on ALS — possible cures, treatment, a clinical trial that could involve Regis — “anything,” Mary Kleiss said.

Her son’s voice is gone, so his words are more carefully chosen these days. It’s tedious work: A reflective dot on Regis Kleiss’ forehead strikes the digital keys on a laptop screen in front of him as he twitches and turns his head to manipulate the words. “Y Me” he wrote, in April:

“It sucks to watch my body fai
l.

“While my mind n emotions r completely intact

“Knowing full well the end result

“And the road I’ll be forced to walk

“Becoming a prisoner in my own body

“Watching my world fly by

“Remembering how life used to be

“Missing so much of life.”

More Details: FOR HELP, INFO

• The ALS Association, based in Washington, advocates for ALS patients. Call 202-407-8580 or visit www.alsa.org.

• ALS of Michigan, based in Southfield, offers programs and services for ALS patients and their loved ones. Among the services are loans for medical and other equipment. Call 800-882-5764 or visit www .alsofmichigan.org .

• The U.S. Centers for Disease Control and Prevention operates a national registry to collect data from ALS patients to help scientists learn more about the disease. The registry and more information about the disease can be found at www.cdc.gov/als.

• The University of Michigan Health System is in Ann Arbor. Visit www.umich .edu and search for “ALS clinic.”

• The Harry J. Hoenselaar ALS Clinic is at Henry Ford Hospital in Detroit. Call 313-916-2835 or visit www.henryford .com/als.

• Mary Free Bed Rehabilitation Hospital is in Grand Rapids. Call 800-528-8989 or visit www .mary freebed.com and search for “ALS.”
COMING MONDAY

Researcher Dr. Eva Feldman campaigns to move ALS trials to U-M

U-M oversees cutting-edge trial that offers hope in fight against Lou Gehrig’s disease

By Robin Erb
Detroit Free Press Medical Writer

Full Story Online Click Here

Sometimes she glares at the painting of Jesus in her dining room.

“I just let it loose,” said Mary Kleiss at her Royal Oak home. “I look at that picture and I say, ‘You get down here and put on your boxing gloves and let’s get this over with.’ I am so damned angry.”

Her son, Regis, was diagnosed two and a half years ago with Lou Gehrig’s disease — amyotrophic lateral sclerosis, or ALS. It is, he writes, “as if God is torturing me.”

The disease kills with stunning efficiency — deadening its victims’ peripheral nerves, withering muscles and, in a final assault, shutting down their ability to breathe. An estimated 30,000 people have it at any given time; 5,000 are diagnosed yearly. Most die within years. There is no cure.

The disease has reduced Regis Kleiss, 28, a formerly thick-bodied shot and discus thrower and captain of the track team at Dondero High School, to a bony echo of himself. Paralyzed except for some minor movement of his head, he will spend his final days on a feeding tube.

ALS leaves its victims’ minds intact.

“It’s a miserable, damned disease,” his mother said.

Now, a clinical trial overseen by the University of Michigan may provide hope. It is cutting-edge and audacious work — the only ALS trial so far in which neural stem cells are injected directly into a patient’s spinal cord. So far, 15 patients have undergone the procedure — two of them twice — as the FDA monitors its safety.

One patient showed a remarkable improvement for a while, though U-M’s Dr. Eva Feldman, who heads the research, cautions not to read too much into that. The other 14 showed no improvement.

The trail is tentative and early. But when the rest of a person’s life has been compressed to an expectancy of two to five years, it is hope nonetheless.

The trial has been based in Atlanta since 2010, but U-M has requested approval from the U.S. Food and Drug Administration to expand it and move it to the University of Michigan in Ann Arbor.

The trial involves injecting 500,000-1 million stem cells into the spine. The ancestry of the cells dates to the spinal cord of an aborted fetus in 2000. The cells are different from the embryonic stem cells that were the subject of a controversial ballot proposal in Michigan in 2008, when voters approved lifting the ban on embryonic stem cell research.

Feldman and others theorize that these new cells act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The procedure worked in rats. It has been shown to be safe in pigs.

If the FDA approves moving the trial to Ann Arbor, Michigan patients will have access to an experimental treatment that not only might offer insight into a disease that kills an estimated 15 Americans a day, but also push back the battle lines against other neurodegenerative diseases, such as Parkinson’s and Alzheimer’s or Huntington’s.

“There is a lot of potential here,” said Sue Burstein-Kahn, executive director of ALS of Michigan, a Southfield-based nonprofit.

Last month, Feldman flew down with a team of U-M staff for the 17th surgery in the trial, in anticipation that the trial might soon move to Ann Arbor. The trial has been at Emory University in Atlanta since it began, in part, because Feldman wanted a former U-M neurosurgery resident, Dr. Nicholas Boulis, who is now at Emory, to perform the delicate procedure. Boulis collaborated with Feldman on her research for seven years during his residency.

Feldman is clear and she repeats this often: This part of the trial tests safety only. By design, it doesn’t
assess the efficacy of the treatment yet.

So the clinical trial patients so far — all from the Atlanta area — know the experimental stem cell therapy probably will not cure them. Still, they’re empowered, knowing their participation might one day cure others, said Ed Tessaro, a retired Macy’s executive, from his home overlooking a sparkling Georgian lake.

The following morning, Tessaro, 66, lay on an operating room table at Emory’s hospital, as doctors sliced through his skin and muscle, removed part of the bone in his spine and laid bare a pulsating, bright-white spinal cord for a second infusion of stem cells.

“It may kill us,” Tessaro said of the disease, “but it’s not going to defeat us before we die.”
Serving a greater purpose

It was 2008 when a single misstep and near-stumble during a half-marathon in Bangkok, Thailand, first worried Tessaro. It happened more than once. His muscles weakened, even as he stepped up his time at the gym.

Months later, a fresh, young doctor delivered the news to him and his wife, Judy.

They remember it well, even now.

“She said, ‘It’s the worst thing I could tell you,’ ” Judy Tessaro recalled.

” ‘You have ALS, and you have two to four years to live,’ ” Ed Tessaro added.

The doctor cried that day. So did Judy and Ed.

“The dynamics are pretty grim — fatal, no cure. Nobody has ever been cured. … It takes a while to get your head wrapped around that kind of reality,” Ed Tessaro said.

But Tessaro took stock. Life had been good, he decided.

Tessaro has been married for 43 years. He has a daughter and son and is a grandfather to two little girls. When he speaks of them, he can’t help but grin. And the pictures in the downstairs rec room at the Tessaros’ home are of a thrill-filled life: ice-climbing in New Zealand, marveling at the lush green of Vietnamese rice paddies, being stunned by the chase-and-dart flurry of a cheetah taking down a Thomson’s gazelle in the Serengeti.

Hiking. Biking. Skydiving.

He thought life couldn’t be more vivid. He was wrong.

Now, every conversation, every gentle touch from his wife, the babbling of his grandbabies — his senses are now in hyperdrive.

“In retrospect, I was living in analog. What I’m now living my life in is high-definition. … I’m living my life fully, because I know I have less of it,” Tessaro said.

When he heard about the clinical trial, Tessaro jumped at it, calling it “the larger-purpose stuff.”

“It’s not like I can hope for a miraculous reversal of this disease — it’s not coming,” he said. “I don’t think I have anything to lose … and I can be part of something bigger. It’s great therapy when you commit yourself to something bigger.”

He became Patient No.12 on April 13. Doctors slipped stem cells into the lower — or lumbar — section of his spine. The area that controls lower body movement, it was considered least risky because Tessaro was already losing the strength in his legs anyway. Clinical trial protocol limits risk.

Tessaro survived. In fact, he left the hospital days earlier than expected and felt better sooner than he expected.

So doctors decided — and the FDA approved — a second, riskier, surgery for Tessaro. This time, doctors would move to the upper — or cervical — portion of Tessaro’s spine, the area in which the nerves are responsible for breathing.

Feldman calls this area “precious real estate,” the stretch of spine where researchers say they believe the treatment may be most effective.

“Higher risk, but maybe higher reward,” Tessaro said, shrugging. He was in the pre-operating room of Emory University Hospital, surrounded by family and overnight bags and medical tubes and equipment.

It was July 20.

In a stretch of hallway and an elevator ride away, a nondescript FedEx box was being delivered to Dr. Jonathan Glass, director of the ALS clinic at Emory. His hands were working quickly.
Preparing for surgery

Glass pulled from the temperature-controlled container several vials of the stem cells known as NSI-566RSC. They had been thawed to about 39 degrees and then shipped overnight to Emory by Neuralstem, a Rockville, Md.-based biomedical company that is funding the trial, according to CEO and President Richard Garr.

The company has shelled out about $2.5 million for the first phase of the trial and provided the stem cells, one of the company’s premier products. They were drawn and cultured from the spine of an aborted fetus in 2000, then cultured again. They remain frozen until the day before they are ready for use.

They have arrived at Emory at 8 a.m. each surgery day of this trial — “never been late,” said Jane Bordeau, a research nurse and coordinator for the trial at Emory.

Glass separated out some of the liquid to test in separate vials, slipping some drops of blue liquid into the vials and tapping them lightly with a middle finger. He slid them onto a slide and rolled his chair to a microscope.

Dead cells will glow blue, he explained, having absorbed a dye that seeps inside their degrading membranes. Live cells remain clear and bright. At least 70% must be alive to be considered viable and to begin surgery, according to Neuralstem.

Glass began counting.

In an upstairs operating room, a red second hand circled a wall clock.

In the pre-op room, Tessaro had been discussing the 25 videos he planned to make for his toddler-age grandchildren. He knows ALS will steal his voice. So he will travel to the Smoky Mountains, set up a tripod and record for them stories, like how he met their grandmother.

He talked about the two books in his overnight bags, too: Hemingway’s “Farewell to Arms,” and — he added, laughing — “Fifty Shades of Grey,” because his daughter dared him.

Nearby, his wife was quiet. She fidgeted with an overnight bag.

In his lab, Glass punched some buttons on his cell phone calculator.

“It’s cool,” he announced. By his calculations, 83.6% of the cells had arrived alive.

It was time. The surgery would go as planned.
Surprising the doctors
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Ted Harada is on Page 8 of the March Journal of Stem Cells, which published the first study announcing the preliminary results of the first 12 patients.

Harada is the anomaly. Patient No. 11. Like Tessaro did last month, Harada this month will undergo a second surgery. And like with Tessaro, it took some time to diagnose the mysterious weakening of Harada’s body.

The former FedEx managing director, now 40, noticed he was getting winded in 2009 while playing Marco Polo in the family pool with his three children: “I’d go under water and come back up, and I was sucking for air.”

After a string of doctors — a family doctor, an orthopedist, a neurologist — the final diagnosis came in August 2010: ALS. The diagnosis was devastating, but the timing couldn’t have been better, the neurologist told him.

Clinical trial #NCT01348451 was under way.

By the time Harada, a self-described type A personality, went in for his surgery in March 2011, he was using a cane, unable to walk to the end of the driveway for the mail without losing his breath or to climb the 15 stairs to tuck his children in at night.

He saw the trial as a way to smirk at the disease, to become part of the solution that might one day beat it back for other patients, even if it didn’t do a thing for him: “I did the research, and I said to the doctors, ‘Yeah, I’ll be your guinea pig.’ ”

To his way of thinking, someone had to be the first man on the moon. Someone has to step up for medical research.

Plus, he added, “I know how the book ends if I do nothing.”

But what happened after his surgery wrote a chapter no one had expected.

The 14 other patients involved in the trial to date have shown no improvement; four have died — three from complications of ALS, and the other from a heart-related issue, according to Neuralstem.

In contrast, Harada put aside his cane soon after the surgery. And he was again tucking his children into their beds.

Feldman is insistent: Don’t read too much into Harada’s turnaround. The number of patients is tiny, and Ted is an oddity among them.

Still, Harada’s improvement, even if temporary, can’t be ignored.

The researchers have used several tests to measure patients’ outcomes, such as breathing capacity, the strength of their handgrip, and even the electrical impulses that flow through their muscles. There on these graphs is Harada, his dotted lines suddenly shooting upward after surgery.

In designing the clinical trial, “we were only aiming at stopping the disease,” said Dr. Karl Johe, chairman and chief scientific officer of Neuralstem. “But this is a patient that has clearly improved.”

Recently, Harada has begun to get winded again climbing the steps to his children’s bedrooms. He and wife, Michelle, 39, a sixth-grade teacher, have explained to their children that he probably won’t get better this time.

In her worst moments, Michelle has foreseen graduations and Christmases and grandchildren without him.

In their kitchen, the Haradas’ children had just finished slathering peanut butter on bread and disappeared upstairs. A deeply religious couple, the Haradas said they’ll take what they can get.

“We’ve been blessed,” he said.

Michelle Harada agreed, struggling against a surge of tears: “The surgery gave us two years back.”
Paving the way for others

Ed Tessaro was facedown, mostly draped in surgery blue in the crowded Emory operating room . It was 12:23 p.m. on July 20.

A stainless steel, crane-like contraption had been screwed into the cervical section of his spine. A steady beep-beep-beep of the monitors punctuated the hiss of a respirator. A digital camera recorded every movement for the FDA.

Standing just a few feet from Boulis, Glass was ready, with the spinal cord exposed.

It was 2:34 p.m. when Boulis asked for the cells.

For the next half hour, the vials were readied for the patented apparatus, on which an injection device slid along a guide to Tessaro’s spinal cord. It would inject 100,000 cells for each of five stops precisely 4 millimeters apart.

The target was the ventral horn of the spinal cord, a tiny area associated with motor neurons.

“Just looking at the spine can hurt it,” Glass had said earlier.

At 3:06 p.m., the injection device slid into place. A needle extended, injecting deep into the spinal cord and, for two minutes, the stem cells were forced into the ventral horn.

At 3:29 p.m., the fifth and final injection began, and two minutes later, the relief was palpable. From her viewing spot just a few yards from Tessaro’s neck, Feldman shifted on her feet and exhaled. The procedure, from start to finish, took a little more than six hours.

Technicians began to check recordings and run over the notes for the FDA. Boulis and the others began the process of removing the device and closing in the gaping hole in Tessaro’s back.

“Can we get some music in here?” Boulis said.

Whiz Khalifa’s rap filled the OR.

Feldman transferred the digital recording of the process to a memory stick she could review back at the office. A copy would go to the FDA, too.

There will be many more months of data, continued animal tests and most likely, hundreds of pages of reports.

Even if this early stage is proved safe and the clinical trial continues, doctors must figure out whether these are the stem cells that work best in this therapy, and, if so, in what amounts and injected into which areas. There’s the issue of the patients’ bodies rejecting these foreign bodies, too.

“This is not a small molecule pill, and your patients go … home and take the pill and you see them in your clinic in a few months,” said Steve Perrin, CEO of ALS Therapy Development Institute, a Massachusetts-based nonprofit focused on finding a treatment or cure for ALS. “These are the challenges this trial and this technology have in front of (them). They’re paving the road, because no one has been down this way before.”

On Friday, Tessaro was recuperating at home.
Waiting for any good news

In the Kleiss’ Royal Oak home these days, Riley the bassett hound has learned that her owner’s lap is no longer hers.

The Kleisses continue to wait for any news they can on ALS — possible cures, treatment, a clinical trial that could involve Regis — “anything,” Mary Kleiss said.

Her son’s voice is gone, so his words are more carefully chosen these days. It’s tedious work: A reflective dot on Regis Kleiss’ forehead strikes the digital keys on a laptop screen in front of him as he twitches and turns his head to manipulate the words. “Y Me” he wrote, in April:

“It sucks to watch my body fai
l.

“While my mind n emotions r completely intact

“Knowing full well the end result

“And the road I’ll be forced to walk

“Becoming a prisoner in my own body

“Watching my world fly by

“Remembering how life used to be

“Missing so much of life.”

More Details: FOR HELP, INFO

• The ALS Association, based in Washington, advocates for ALS patients. Call 202-407-8580 or visit www.alsa.org.

• ALS of Michigan, based in Southfield, offers programs and services for ALS patients and their loved ones. Among the services are loans for medical and other equipment. Call 800-882-5764 or visit www .alsofmichigan.org .

• The U.S. Centers for Disease Control and Prevention operates a national registry to collect data from ALS patients to help scientists learn more about the disease. The registry and more information about the disease can be found at www.cdc.gov/als.

• The University of Michigan Health System is in Ann Arbor. Visit www.umich .edu and search for “ALS clinic.”

• The Harry J. Hoenselaar ALS Clinic is at Henry Ford Hospital in Detroit. Call 313-916-2835 or visit www.henryford .com/als.

• Mary Free Bed Rehabilitation Hospital is in Grand Rapids. Call 800-528-8989 or visit www .mary freebed.com and search for “ALS.”
COMING MONDAY

Researcher Dr. Eva Feldman campaigns to move ALS trials to U-M.