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Mich. university joins Lou Gehrig’s clinical trial

USAToday

USATodayhttp://www.usatoday.com/story/news/nation/2013/04/18/lou-gehrigs-disease-clinical-trial/2094867/

Mich. university joins Lou Gehrig’s clinical trial

Robin Erb, April 18, 2013

Study is only one if its kind because neural stem cells are injected into the spinal cord.

(Photo: Kimberly P. Mitchell, Detroit Free Press)

Story Highlights

  • University of Michigan joins Emory University in Atlanta in the clinical trial
  • In the study, human neural cells are injected directly into patients’ spinal cord
  • Currently, there is no cure for amyotrophic lateral sclerosis or ALS

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A clinical trial using human neural stem cells to halt or even reverse the deadly effects of Lou Gehrig’s disease may begin recruiting patients at the University of Michigan as early as this summer.

Until now, the surgeries have taken place at Emory University in Atlanta, led in part by a former U-M neurosurgery resident, Dr. Nicholas Boulis, and overseen by U-M physician and neurology professor Dr. Eva Feldman. The trial is the only one if its kind because the neural stem cells are injected directly into the spinal cord.

At Emory, 15 patients underwent surgery during Phase I, which was focused primarily on safety. At least one appeared to improve dramatically for a short time, regaining use of his legs. Feldman attended each surgery.

The go-ahead Monday by the U.S. Food and Drug Administration to expand the trial to Phase II means the surgeries can take place at U-M as well. The second phase will involve 15 patients split between U-M and Emory, according to U-M and the provider of the stem cells, Maryland-based Neuralstem.

Participants must be ambulatory and live close to those universities.

Currently, there is no cure for amyotrophic lateral sclerosis, often called ALS or Lou Gehrig’s disease. One drug extends life, but usually just by months.

The disease moves swiftly, with most people living two to five years after diagnosis. ALS deadens nerves, withers muscles and, in a final assault, cuts off a person’s ability to breathe even as their mind remains intact.

Dave Murray, 55, of Sterling Heights, Mich., said Wednesday he was “thrilled” by the trial’s move to U-M, though it’s unclear whether he would be eligible.

The former security alarm installer already has been a participant in two other clinical trials.

“I might be past the point of eligibility, but I’m always happy with any news that we might be moving forward,” he said. “It’s such a horrible disease.”

Two years ago, he was sitting with his coat draped over his arms on an exam table when a doctor gave him the diagnosis, and told him he had three, maybe five, years left. Only the sound of his doctor washing her hands at the tiny sink broke the suffocating silence that followed.

“The doctor, she was very compassionate,” recalled his wife, Sheryl Murray. “She left us room to cry. She said, ‘Take whatever time you need.'”

Feldman, the physician overseeing the trial, has spent her career stalking ALS and searching for a cure. She has watched helplessly as countless patients have died over the years — as many as five a week and as young as 16, she told the Free Press in 2012.

The trial is still early and will move slowly as she and other researchers continually assess their results and report the findings to the FDA.

Phase II means researchers can begin assessing the effectiveness of the procedure, not just its safety. In a lengthy surgery, a specially designed apparatus is attached to the spine and inserts human stem cells into a person’s spinal cord.

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

The cells were derived from a cell line that 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.

U-M’s Institutional Review Board, which oversees clinical trials to make sure they are scientifically and ethically sound, must sign off on the experimental surgeries before U-M begins recruiting.

Despite its limitations, the trial offers hope for those who see little of it once they are handed a diagnosis, said Sue Burstein-Kahn, executive director of ALS of Michigan. Her father died of ALS.

She called the FDA approval “wonderful” in that it could provide insights to a treatment for future patients.

“We need ALS research fast-tracked,” she said.

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U-M may recruit ALS patients for stem cell clinical trial

Detroit Free Press
Detroit Free Presshttp://www.freep.com/article/20130417/NEWS06/304170160/U-M-may-recruit-ALS-patients-stem-cell-clinical-trialDr. Eva Feldman is overseeing the clinical trial. / Detroit Free Press

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By Robin Erb
Read the full article by clicking here

A clinical trial using human neural stem cells — injected into the spinal cord — to halt or even reverse the deadly effects of Lou Gehrig’s Disease may begin recruiting patients at the University of Michigan as early as this summer.

Until now, the surgeries have taken place at Emory University in Atlanta, led in part by a former U-M neurosurgery resident, Dr. Nicholas Boulis, and overseen by U-M physician and neurology professor Dr. Eva Feldman. The trial is the only one if its kind because the neural stem cells are injected directly into the spinal cord.

At Emory, 15 patients underwent surgery during Phase I, which was focused primarily on safety. At least one appeared to improve dramatically for a short time, regaining use of his legs. Feldman attended each surgery.

The go-ahead Monday by the U.S. Food and Drug Administration to expand the trial to Phase II means the surgeries can take place at U-M as well. The second phase will involve 15 patients split between U-M and Emory, according to U-M and the provider of the stem cells, Maryland-based Neuralstem.

Participants must be ambulatory and live close to those universities.

Currently, there is no cure for amyotrophic lateral sclerosis, often called ALS or Lou Gehrig’s disease. One drug extends life, but usually just by months.

The disease moves swiftly, with most people living two to five years after diagnosis. ALS deadens nerves, withers muscles and, in a final assault, cuts off a person’s ability to breathe even as their mind remains intact.

Dave Murray, 55, of Sterling Heights said Wednesday he was “thrilled” by the trial’s move to U-M, though it’s unclear whether he would be eligible.

The former security alarm installer already has been a participant in two other clinical trials.

“I might be past the point of eligibility, but I’m always happy with any news that we might be moving forward,” he said. “It’s such a horrible disease.”

Two years ago, he was sitting with his coat draped over his arms on an exam table when a doctor gave him the diagnosis, told him he had three, maybe five, years left. Only the sound of his doctor washing her hands at the tiny sink broke the suffocating silence that followed.

“The doctor, she was very compassionate,” recalled his wife, Sheryl. “She left us room to cry. She said ‘Take whatever time you need.’ ”

Feldman, the physician overseeing the trial, has spent her career stalking ALS and searching for a cure. She has watched helplessly as countless patients have died over the years — as many as five a week and as young as 16, she told the Free Press in 2012.

The trial is still early and will move slowly as she and other researchers continually assess their results and report the findings to the FDA.

Phase II means researchers can begin assessing the effectiveness of the procedure, not just its safety. In a lengthy surgery, a specially designed apparatus is attached to the spine and inserts human stem cells into a person’s spinal cord.

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

The cells were derived from a cell line that 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.

U-M’s Institutional Review Board, which oversees clinical trials to make sure they are scientifically and ethically sound, must sign off on the experimental surgeries before U-M begins recruiting.

Despite its limitations, the trial offers hope for those who see little of it once they are handed a diagnosis, said Sue Burstein-Kahn, executive director of ALS of Michigan. Her father died of ALS.

She called the FDA approval “wonderful” in that it could provide insights to a treatment for future patients.

“We need ALS research fast-tracked,” she said. “This isn’t even about a cure. People would be happy with the treatment.”

Contact Robin Erb: 313-222-2708 or rerb@freepress.com.

Kofi Myler

What’s next?

■A University of Michigan Institutional Review Board will review the protocols for the trial, considering the ethics and science of the experimental procedure.
■ The university cannot begin recruiting until the the board OKs the trial. The approval process could take months.
■ Once approval is given, the research team, made up of doctors, nurses, researchers and others, may begin recruiting. Because the trial will likely involve fewer than 15 patients at U-M, it’s unclear how they will be recruited.
■U-M most likely will post recruiting information on its clinical trials website,www.umclinicalstudies.com. For general information for ALS patients wishing to take part in U-M research, e-mail jkballar@umich.edu.

Kofi Myler
Kofi Myler

 

 

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Scientists Seek Stem Cell Cure For Spinal Cord Injuries

WAMU

WAMUScientists Seek Stem Cell Cure For Spinal Cord Injuries

By: Emily Berman // January 25, 2013

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or continue to read the condensed transcript here
Thomas Hazel PhD and Richard Garr @Neuralstem
Thomas Hazel, Ph.D, and Richard Garr pose in their neural stem cell laboratory, in Rockville, Md.

Neuralstem, a Rockville-based biotech company, has just been approved by the FDA to begin implanting stem cells into people with spinal cord injuries. While there’s a long scientific journey ahead, this trial could mean hope for paraplegic and quadriplegic patients all over the world.

The nervous system works, by sending electrical signals up and down the spinal cord. Degenerative diseases like Multiple Sclerosis, ALS, or Parkinsons impair the ability to send those signals. “There’s a gap,” says Richard Garr, co-founder and CEO of Neuralstem. He says there’s something that’s blocking signals from getting through.

Unlike our skin cells, the central nervous system doesn’t repair itself when damaged. “You’re born with a certain number of neurons, and that’s the way it is.” says Garr.

In 1998, Garr met Karl Johe, Ph.D. who had made a discovery while working at NIH. Around week 7 or 8, when the human embryo is the size of the tip of your thumb, there are cells in the brain area of the embryo that have all the information they need to become neurons. These are called ‘neural stem cells.’ Dr. Johe developed and patented techniques for extracting and multiplying these cells, then implanting them as ‘replacement neurons.’

“We’re actually putting in cells that are going to turn into neurons that are going to bridge the gap,” he says. “We’re creating new circuitry.”

Dr. Thomas Hazel, the head of Research at Neuralstem, explains one of the most important aspects of neural stem cells is that they can easily replicate. The lab received a donated tissue from a legally aborted fetus about 10 years ago, and they’ve been using those cells ever since.

The surgery recently approved by the FDA is much like an earlier trial, done on ALS patients. The surgeon injects neural stem cells directly into the patient’s spinal cord. Those stem cells grow into neurons, and if all goes according to plan, they help messages pass from the brain to muscles.

The ALS trial is waiting for phase 2 approval, but patients, on their own, are reporting some improvement. The spinal cord trial will take on eight patients who have experienced injury in the past 1 to 2 years in the thoracic spine, which is from the chest, down. Neuralstem will announce the partner hospitals in the coming months, and hope to start the surgeries in summer 2013.

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Bespoke Stem Cells for Brain Disease

excerpt from article: “Over the last 2 years, stem cell therapies have done well in early clinical trials for sporadic neurological diseases, such as ALS and macular blindness. Such therapies have also shown promise for spinal cord injury, and just this week, the US Food and Drug Administration gave approval to the biopharma NeuralStem to begin a Phase I trial with fetal stem cells. It is the second US stem cell trial for spinal cord injury;“

Click Here to read the online article

TheScientist

Bespoke Stem Cells for Brain Disease

Scientists use virus-free gene therapy on patient-derived stem cells to repair spinal muscular atrophy in mice.

By Nsikan Akpan | January 15, 2013

Most children with spinal muscular atrophy (SMA) will never jump rope, play tag, or even walk because a genetic deletion will provoke the gradual destruction of their spinal motor neurons. By correcting this mutation in stem cells derived from patients, Italian scientists have successfully curbed the progression of the disease in a mouse model. The results, published last month (December 15) in Science Translational Medicine, suggest that SMA sufferers may one day serve as their own donors for neuron transplants to treat their disease, according to a report.

“[It] is a beautiful study of the potential for using induced pluripotent stem cells (iPSCs) to treat genetic diseases,” said Lisa Ellerby from Buck Institute for Research on Aging, who was not involved in the study but is currently investigating the use of the technique to treat Huntington’s disease (HD).

Over the last 2 years, stem cell therapies have done well in early clinical trials for sporadic neurological diseases, such as ALS and macular blindness. Such therapies have also shown promise for spinal cord injury, and just this week, the US Food and Drug Administration gave approval to the biopharma NeuralStem to begin a Phase I trial with fetal stem cells. It is the second US stem cell trial for spinal cord injury; Geron abruptly halted the first in 2011.

Adding gene correction to the equation could expand their scope to treat a wide array of inherited disorders, Ellerby said. “As the field demonstrates that patient cells can be genetically corrected, we are closer to using this new technology to either model the disease or develop therapies for human patients.”

SMA is the leading genetic cause of infant mortality, killing one of every 6,000 babies born worldwide. The disease arises when a person fails to inherit a partially deleted version of the survival motor neuron 1 (SMN1) gene, which regulates multiple cellular processes involved with RNA metabolism. There is no cure.
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Somewhere along the evolutionary road to becoming human, the SMN1 gene was duplicated, resulting in SMN2, which can partially compensate for the dearth of SMN1 in SMA patients. Every SMA patient possesses an SMN2 gene. Those with multiple copies of SMN2 experience less severe SMA and typically survive into adulthood. But SMN1 and SMN2 are not identical: a single nucleotide difference impairs the pre-mRNA splicing of SMN2, such that its functional protein is produced at one-tenth the rate of the SMN1 protein.

Neurologist Giacomo Comi of the Univerity of Milan reasoned that if the single differing nucleotide of SMN2 were changed to mimic SMN1 in spinal neurons, perhaps the cells could survive. Rather than correct the SMN2 gene in endogenous SMA neurons, which may be dead or dying by the time the disease is recognized, Comi proposed replacing them entirely with iPSC transplants carrying a corrected copy of SMN2.

“The ideal therapeutic approach for SMA will be a combined strategy of molecular therapy to resolve the genetic defect and cell transplantation that can complementarily address signs of the disease,” said first author Stefania Corti of the University of Milan.

To accomplish this goal, Comi and his colleagues reprogrammed skin cells from SMA patients into iPSCs. The researchers then transfected the iPSCs with sequence-specific oligonucleotides that can repair genes with single base mutations. (In both steps, the researchers avoided using viral vectors because of the risks of tumor formation or harmful immune responses following transplantation.)  Finally, the genetically altered iPSC cells were differentiated into motor neurons and transplanted into mice that displayed symptoms of SMA.

SMA pups that received spinal grafts of “corrected” SMA-iPSC-derived neurons a day after birth showed significantly less spinal neuron loss and muscle atrophy. They were more physically active and stronger, as judged by open-field and grip tests. Neuron transplantation also extended lifespan by 50 percent.

The results suggest that the implanted neurons integrated into the spinal cord to alleviate motor dysfunction. Indeed, fluorescent histology revealed that the transplanted neurons formed neuromuscular junctions with muscle tissue near the spine. The implanted neurons also promoted the survival of the endogenous neurons still carrying the SMA mutation, indicating that the therapy provided neuroprotective benefits to the surrounding tissue as well. When grown in culture, corrected iPSC-derived neurons secreted more growth factors than uncorrected neurons, which may explain this transfer of vitality.

Of course, the research is very early stage, and many years of work will be needed to translate this success to the clinic, but “the implications are significant, not just for SMA disease, but also for similar neurodegenerative conditions like ALS and other neuromuscular diseases,” said Corti. “These data demonstrate the feasibility of generating patient-specific cells that are free of disease.”

S. Corti et al., “Genetic correction of human induced pluripotent stem cells from patients with spinal muscular atrophy,” Science Translational Medicine, 19:165ra162, 2013.

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Neuralstem’s stem cells give spinal injury patients hope

Neuralstem’s stem cells give spinal injury patients hope

FDA gives Rockville biotech green light for initial trial

By Lindsey Robbins

This story was corrected on Jan. 15, 2013. An explanation follows the story.

Richard Garr NeuralStem CEO
Richard Garr NeuralStem CEO

Physicians, researchers, patients and their advocates in the spinal injury field are keeping a close eye on Rockville biotech Neuralstem as it prepares to launch a Phase 1 safety trial of its stem cell treatment for chronic spinal cord injury.

The Food and Drug Administration approved the trial Monday. Neuralstem plans to conduct the study on eight patients who are completely paralyzed at or below their spinal cord injuries.

“It’s important that people understand this is very different from other methods that have gone on before,” CEO Richard Garr said. “This is the real deal. We have compelling data. Cells are surviving, grafting and doing what we would expect they would do.” The FDA go-ahead follows Neuralstem’s report in October that rats given the stem cell product, NSI-566, seven days after suffering an ischemic stroke showed improvement in motor and neurological tests.

“Should this prove to be successful, it will allow for some regeneration of human spinal cord cells and for people to regain function. It will be an incredible breakthrough, with huge implications for the health care market,” said Paul Tobin, president and CEO of the National Spinal Cord Injury Association.

More than 10,000 people in the U.S. sustain spinal cord injuries each year, according to the Christopher & Dana Reeve Foundation. About 840,000 people have chronic spinal cord injury. Currently, the best treatment is mitigating secondary damage and providing environments and tools that support patients with these injuries, Tobin said.

While Tobin emphasized that the industry is still “far from a cure yet,” the Neuralstem treatment could be a tremendous step and appears to be worth exploring.

The primary objective of the study is to determine the safety and toxicity of human spinal stem cell transplants for treating paralysis and related symptoms due to chronic spinal cord injury, according to Neuralstem information. A secondary objective is evaluating graft survival in the transplant site.

All patients will receive six injections in or around the injury site, with the first four patients receiving 100,000 cells per injection and the second four receiving 200,000 cells per injection. The study will follow the patients for six months after the procedures.

Following Monday’s announcement, stock analyst Aegis Capital of New York raised its 12-month price target for Neuralstem to $4 from $3.50.

“Investors should note the fact that spinal cord injury is the clinical indication that most closely mirrors the situation in the preclinical rat model that yielded the ground-breaking data published in the [trade journal] Cell last year,” Aegis wrote in a report Monday.

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Aegis described itself as “cautiously optimistic” about Neuralstem’s treatment, but said the stem cell lines are still in “comparatively” early stages of development and that stem cell research, in general, faces uncertainty. Neuralstem’s stem cells are not from embryos.

Aegis also cautioned that Neuralstem had $9.9 million in cash and equivalents as of Sept. 30, with a monthly cash burn estimated as high as $1.5 million. Garr said Neuralstem is not planning fundraising in the immediate future.

Garr said the Phase 1 trial should begin this spring.

Other stem cell studies

Next month, Neuralstem plans to begin dosing patients with NSI-566 to treat paralysis from stroke in China, with a trial in Korea scheduled for the summer.

Neuralstem already has completed dosing in its Phase 1 trial at Emory University in Atlanta for amyotrophic lateral sclerosis. The trial will end six months after the last surgery. That therapy has received orphan status designation from the FDA, which confers certain advantages, such as a more streamlined process.

Though other companies have looked into this treatment, Neuralstem is the only one with an FDA-approved spinal cord injury trial using stem cells.

Geron Corp. in California had been conducting stem cell spinal cord injury trials in the U.S. but ended up shutting down that portion of its business in November 2011 and later sold it. StemCells is conducting trials in Switzerland.

Neuralstem officials said they hope success with this treatment allows for applications in chronic stroke motor disorder and multiple sclerosis.

“People should take hope,” Garr said.

Karl Johe, Neuralstem’s chairman and chief scientific officer, said the biotech’s data from other studies justify the new trial and the company’s confidence.

“In addition to the pre-clinical animal data, we have conducted 18 successful surgeries using the same cells and surgical device in our ALS trial,” Johe said in a statement. “That trial has demonstrated that the surgical route of administration and the cells are safe and well-tolerated and that the cells survive long-term in the patients. The successes of our human clinical experience, combined with the compelling data from the preclinical spinal cord injury animal studies gives us confidence that we are prepared to move into this additional indication for NSI-566.”

lrobbins@gazette.net

Explanation: The original version omitted a word from this quote by Richard Garr: “Cells are surviving, grafting and doing what we would expect they would do.”

Posted on

ALS patient is living his second miracle

http://www.crainsdetroit.com/article/20121130/BLOG007/121139991/als-patient-is-living-his-second-miracle

ALS patient is living his second miracle

Follow-up stem-cell operation has more amazing results

November 30, 2012

ALS patient is living his second miracle

Follow-up stem-cell operation has more amazing results

Emory University Hospital
Doctors inject stem cells into ALS patient

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Ted Harada is living his second miracle right now, savoring every minute of every hour of it for as long as it lasts. His strength is back up, there’s a spring in his step, he’s got a strong grip back in his hands, and the symptoms of his ALS once again are in retreat to the ongoing surprise of his doctors and to the delight of his family.

Once again, Harada is easily going up the stairs to tuck his kids in at night and give them a kiss, instead of struggling up a step at a time, having to hold onto the handrail for support. Once again, he knows — or is as close to knowing as you can with such a disease — that he is part of something that will eventually change the death-sentence prognosis that until now has been a certainty as soon as there is a diagnosis with the dreaded words no one wants to hear: amyotrophic lateral sclerosis — Lou Gehrig’s disease.

“The first time, it’s easy to say it was an outlier. Luck. But I’ve been helped twice. Twice, and you can throw luck out the window. They’ve got to figure out, now, what’s going on with me,” he says. “We’ve got to turn Lou Gehrig’s disease into Lou Gehrig’s chronic illness.”

Some background: I interviewed Harada by phone in early October for a package of stories Crain’s ran Oct. 29 about successful Phase 1 human trials that University of Michigan and Emory University physicians and researchers had recently concluded in Atlanta, injecting stem cells into the spinal column of ALS patients.

Because Phase 1 trials are designed to test safety before any approval from the Food and Drug Administration to move on to Phase 2 trials, which test efficacy, researchers are cautious. They generally decline much comment for fear about running afoul of the bureaucrats.

But patients themselves are free to talk to anyone they want, and Harada was eager to tell his tale.

Ted Harada

 

Harada, 40, is a former manager at FedEx who first noticed symptoms of ALS in 2009 while playing Marco Polo with his kids in the family swimming pool.

On March 9, 2011, he got an injection of 500,000 stem cells — the cells were derived by Rockville, Md.-based Neuralstem Inc. after a patient donated spinal-cord tissue in 2002 — as part of an 18-operation, 15-patient trial that last 2½ years.

The operations were conducted by Emory University Hospital physician Dr. Nicholas Boulis. The trial was designed, in part, by Dr. Eva Feldman, director of the A. Alfred Taubman Medical Research Institute at UM and director of the ALS clinic at the University of Michigan Health System. Boulis is a former colleague of hers at UM.

Harada was one of three patients who got two rounds of injections, the second this past Aug. 22. Researchers monitored all patients for side effects, of course, and the trials proved to be remarkably safe. The results were presented by Feldman in October at the annual meeting of the American Neurological Association in Boston.

Researchers also do a variety of tests on patients to look for signs of efficacy, too, to give them an idea of what they might expect should they get to Phase 2. Some patients showed little or no improvement. Others had modest gains.

Harada was off the charts.

When I interviewed Harada, he was feeling punk from fighting off a lingering staph infection and thought he was starting to see an improvement in symptoms as a result of the injection of cells Aug. 22. Because of the infection, it was hard to tell, and researchers at Emory hadn’t begun doing follow-up tests with him.

University of Michigan
Eva Feldman

 

But there was no equivocation about the miracle that had happened after Harada’s first injection.

Two weeks after the operation, Harada thought he was feeling stronger, that there had been an improvement in his overall health. But he was afraid he was imagining things. That it was wishful thinking. Or a placebo effect.

Before the operation, Harada could barely limp with the help of canes or handrails up the steps to say goodnight to his kids at his home in McDonough, Ga. If he sat in a chair and his wife put the least bit of resistance on the top of his knee, he couldn’t budge his leg off the ground.

Harada didn’t wait for the doctors to test him.

“I asked my wife to come over and give me a test,” he told me in October.

She braced her hand against the top of his knee, as she had done many times. This time, though, his foot didn’t stay planted on the ground. It went up in the air.

They tried it, again. She pushed harder. He lifted his leg. A third time, his wife really pressing down her hand.

He lifted his leg.

She pushed down with two hands. He lifted his leg. “It was shock. ‘Is this real? This isn’t supposed to happen,’ ” Harada recounted to me.

He called the folks at Emory to tell them the news. He doesn’t blame them for what happened next. They tried to temper his enthusiasm. They explained the power of placebo effects.

“I know what a placebo effect is. I’m not crazy. This isn’t a placebo effect,” Harada responded.

“If anyone was more surprised than me, it might have been my doctors,” he told me.

Subsequent tests showed emphatically that what was going on — the mechanism of which is still not understood — was clearly not a placebo. Across a range of tests, there was demonstrative, clear, seemingly miraculous improvement.

“Every night I went to bed worried I’d wake up and it would be gone, that I’d have made the whole thing up,” he said. And every day for two or three months, not only did he wake up and hadn’t made the whole thing up, he woke up stronger than when he went to bed.

“I continued to improve in quantum leaps,” he said.

About a year after the operation, Harada began to notice a gradual decline, a decline that continued until his second operation — though he was still stronger when he went into the second operation than he had been going into the first.

When I talked to him in October, Harada was pretty sure he was feeling a little better but was tempering his expectations. “It would have been greedy to expect such good results, again,” he said.

Today, though, his staph infection has been cleared up, and there’s empirical evidence another miracle is taking place.

“I’m definitely getting stronger, there’s no doubt. Tests are showing beyond a doubt I’ve gained strength again,” Harada said. “I have more energy. My legs don’t get tired as quickly as they did. My hands have gotten stronger, again.”

By Oct. 20, Harada was feeling strong enough that he took part in a 2.5-mile fundraising ALS walk in Atlanta.

“If the walk had been in July, I wouldn’t have attempted it,” he said. “After a third of a mile, I would have been done. I would have sat down and said, ‘Someone come pick me up in a car.’ ”

Harada did the 2.5 miles, no problem, still going strong when he hit the finish line.

Harada said one researcher told him after putting him through his tests on a visit earlier this month that, in Harada’s words: ” ‘If I hadn’t seen it with my own eyes, I wouldn’t believe it. If I was at another hospital and reading reports about you, I’d say it had to be B.S.’

“I’ve been blessed beyond belief,” he said.

Harada still has ALS. He still knows the likely prognosis is death. For him. But based on what has happened to him, there’s hope the prognosis of death won’t always accompany the diagnosis. Not now, not that there’s clearly some possible mechanism for improvement, something researchers need to understand and refine.

Feldman is awaiting approval from the FDA for a Phase 1B trial that she hopes will begin soon in Ann Arbor. It involves injecting three patients with 1 million stem cells, double the dose of the first trials.

If there are no ill effects from doubling the amount of stem cells, a Phase 2 study of 32 patients could begin next summer.

It’s worth repeating Harada’s words: “We’ve got to turn Lou Gehrig’s disease into Lou Gehrig’s chronic illness.”

Based on what’s happened, and what is happening, with Harada, that no longer seems like wishful thinking.

 

 

 

 

 

 

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Advancing on ALS

Eva Feldman

http://www.crainsdetroit.com/article/20121028/SUB01/310289962/advancing-on-als

October 28, 2012 8:00 PM

Advancing on ALS

Stem cell research nears next phase; trials may come to Ann Arbor
By Tom Henderson

Eva Feldman
Eva Feldman, director of the A. Alfred Taubman Medical Research Institute at the University of Michigan and director of the ALS clinic at the UM Health System

Approval by the U.S. Food and Drug Administration is expected any day for researchers and physicians at the University of Michigan to begin a second round of Phase 1 stem cell trials on patients with amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s disease.

ALS is a disease of the nerve cells in the brain and spinal cord that control voluntary muscle movement. It usually leads to death within three to five years. Currently, there is no cure.

The first round of Phase 1 trials, which lasted 21/2 years and concluded Aug. 22, involved 18 operations that injected stem cells into the spines of 15 patients, three of whom were injected twice. The operations were conducted at Emory University Hospital in Atlanta by Nicholas Boulis, M.D.

Eva Feldman, M.D., director of the A. Alfred Taubman Medical Research Institute at UM and director of the ALS clinic at the University of Michigan Health System, helped design the study. Boulis is one of her former colleagues at UM.

The first study was to test safety only. and it passed with flying colors, according to a report Feldman issued this month at the annual meeting of the American Neurological Association in Boston, held in cooperation with the British Association of Neurologists. Feldman is president of the American group.

Four of the study patients died, three from ALS complications and one from a heart problem. But no safety issues arose from the study itself.

“It went better than I anticipated and could have ever hoped for,” Feldman said of the Phase 1 trial. “There were no adverse affects.”

The Phase 1B trial, which could begin as early as December, will involve injecting just three patients and will be conducted, pending FDA approval to move the trials to Ann Arbor from Atlanta, by Parag Patil, a UM physician.

The first trial involved injections of 500,000 stem cells. This trial will inject at least 1 million cells. The trials use a stem sell line derived at Rockville, Md.-based Neuralstem Inc. after a a patient donated spinal cord tissue in 2002.

If there are no ill effects from doubling the amount of stem cells, a Phase 2 study of 32 patients to test efficacy could start as early as next summer.

“It’s really exciting to bring this back to Michigan,” Feldman said. “The climate now for this is very embracing — not just in the state but in the university, too.”

Feldman was referring to the contentious climate for stem cell research in Michigan that culminated in voters’ approving embryonic stem cell research in 2008. One reason that the first trial was in Atlanta and not Ann Arbor was that all stem cell work got tarred with the same brush, she said.
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Although Feldman’s trials didn’t use embryonic stem cells, it was thought that Atlanta was a better place to start them. “I used to get these letters and emails against what we were doing,” she said, “but that’s stopped.”

Feldman said that while the primary purpose of the Phase 1B trial will be to test safety, it has been designed to test efficacy, too.

One post-surgery test on the three patients will use ultrasound to evaluate the movement of the patients’ diaphragm. Other tests will investigate how forcefully patients can expel their breaths and how much oxygen they can inhale.

“One of the purposes of the injections is to protect the large nerve cells that control breathing,” Feldman said. An inability to breathe is what ultimately kills many ALS patients.

Based on anecdotal evidence of improvements in some patients in the first round of safety tests (see story, Page 11), Feldman expects to see dramatic results in at least some patients — if not in the upcoming three-patient trials, then in the Phase 2 trials to follow.

The exact mechanism behind why stem cells helped rats and pigs in animal studies and now seem to have helped some patients is unclear. Feldman theorizes that the cells turn on repair signals inside the body, act as nursemaids for the damaged cells and slow, if not halt, the progression of the disease.

“This was something that had never been done before, and there was a lot of skepticism in the medical community — and ‘skepticism’ is a pretty polite word,” Feldman said of a procedure to inject stem cells into the spine of patients.

“Now that we’ve taken this idea and not only shown it’s feasible but safe, it’s opened up doors.”

In July, Clive Svendsen, Ph.D., director of the Cedars-Sinai Regenerative Medicine Institute in Los Angeles, was awarded an $18 million grant from the California Stem Cell Agency to do a Phase 2A study of 18 patients patterned after the UM-Emory study, using a stem cell line he derived.

The study, designed to test both safety and efficacy, will be done at three sites, including six operations by Boulis at Emory.

Svendsen, with Boulis, had begun work on the line in 2003 at the University of Wisconsin before Boulis’ partnership with Feldman. Troubles with that line, which included a drug that was genetically engineered into the stem cells, took years to surmount.

Svendsen’s stem cells are engineered to use a drug called glial-derived neurotrophic factor, a growth factor designed to help protect neurons from the effects of ALS.

Feldman is optimistic that Phase 2 trials on ALS patients will be so successful that she will be able to get funding and gain FDA approval to begin similar stem cell trials on patients with Alzheimer’s disease. She has been working on a grant from the National Institutes of Health to fund an Alzheimer’s study.

“We shouldn’t limit this technology to one disease,” Feldman said.

In part, that’s because there is a far larger population of Alzheimer’s patients than ALS patients, and in part because the brain can be injected with far more stem cells than can the spinal cord.

As a result, trials should be easier to conduct and therapies easier to devise.

Said Feldman: “Alzheimer’s is going to be easier than ALS.”

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Paralyzed Rats Walk Again After Stem Cell Transplant

Technology Review Published by MIT

http://www.technologyreview.com/view/429222/paralyzed-rats-walk-again-after-stem-cell/

The rodent recovery spurs hope that humans could one day benefit from similar treatments.

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

Thursday, September 13, 2012

Rats once paralyzed from complete surgical cuts through their spinal cords can walk again after stem cells were transplanted into the site of the injury, report <http://www.sciencedirect.com/science/article/pii/S0092867412010185> researchers today in the journal Cell. The results suggest that stem cells might work as a treatment for patients even if they have completely severed cords, a potential therapy that has been viewed skeptically by many in the
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Neural stem cells, derived from aborted fetal spinal cord tissue, were
implanted onto each side of the spinal cord injury in the rats along with a supportive matrix and molecular growth factors. The human stem cells grew into the site of injury and extended delicate cellular projections called axons into the rats spinal cord, despite the known growth-inhibiting environment of the injured spinal cord. The rats’ own neurons sent axons into the transplanted material and the rats were able to move all joints of their hind legs.

The cells are produced by a Rockville, Maryland company called Neuralstem <http://www.neuralstem.com/> . The same cells are also being tested in ALS patients (see “New Cells for ALS Patients
<http://www.technologyreview.com/news/428956/new-cells-for-als-patients/> “) where they have shown some promise of stabilizing the progressive disease. Last month, the company announced
<http://investor.neuralstem.com/phoenix.zhtml?c=203908&p=irol-newsArticle&ID=1463178&highlight> that it has asked to FDA to approve a trial to test the cells in spinal cord-injured patients.

Researchers are currently testing neural stem cells from a Newark,
California-based company called StemCells Inc. <http://www.stemcellsinc.com/> , in spinal cord injured patients; two of the three patients have reported the recover of some sensation (see “Human Stem Cells Found to Restore Memory <http://www.technologyreview.com/news/428532/human-stem-cells-found-to-restore-memory/> ” for an overview of the company).

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Advances in regenerative medicine may let patients grow own transplants

Modern medicine:

Advances in regenerative medicine may let patients grow own transplants

http://www.msnbc.msn.com/id/48976348/ns/health-mens_health/

By Maggie Fox

NBC News

A few years ago, Dr. Anthony Atala’s lab at Wake Forest University got good at making ears. They were growing new ears on a scaffold using patient’s cells, because so many soldiers were losing their ears in explosions. Now the Department of Defense has a project that’s closer to Atala’s heart: making new genitals for soldiers who have stepped on bombs.

Other labs are still moving forward with the ear project for the military.  But Atala has special expertise dating back to his days as a pediatric urologist. He’s already grown bladders using a patient’s own cells, and he’s made penises that rabbits were able to put to their proper use, fathering litters of new little bunnies. He hopes to use this expertise to help rebuild the bodies of veterans wounded in Iraq and Afghanistan, as well as men and boys injured in car accidents.

Atala is one of the pioneers of regenerative medicine. But the field has
taken off in a big way, attracting biotechnology companies, the U.S.
military and academic labs, which are working to literally make the blind see and the lame walk again. They’re perfecting spray-on skin and to mass-produce new body parts using bioprinters based on the jet printers attached to your home computer.

“Right now, the way these organs are made is creating them one by one. By bringing the bioprinting in, we can scale it up,” says Atala, whose lab has contracts with the four-year-old Armed Forces Institute of Regenerative Medicine (AFIRM), biotechnology companies and private foundations.

All of this technology is years away from the doctor’s office. The most
advanced treatments have just begun the very earliest stages of human testing. But all evidence points to the tantalizing prospect of
grow-your-own organs and possibly even limbs within a decade or so, and some approaches, such as muscle transplants and spray-on skin, are helping a lucky few now.

Atala’s lab in 2006 made the first full organ ever grown and implanted into a human – the bladder – and the rabbit penises were the first solid organs. A new bid from AFIRM caught his eye. It called for experts in rebuilding the lower abdomen, the genitals, the pelvic area and the bladder.

These injuries are among the least talked-about but among the most horrible affecting war veterans. The improvised explosive devices, or IEDs, planted by insurgents across Iraq and Afghanistan blow off feet, legs and arms, and they can especially damage the pelvic areas that are difficult to protect with body armor.

Atala’s lab is also working to make kidneys, muscle implants, and even to find ways to get fingers to regenerate on their own. (It has to do with waking up some very powerful DNA that goes to sleep soon after a fetus develops). AFIRM’s mission is to align labs like Atala’s with others around the country, getting them to collaborate on projects rather than compete.  AFIRM currently funds around 50 research labs, including leaders such as the University of Pittsburgh Medical Center, Rutgers University, the Cleveland Clinic and Rice University.

“We don’t really feel that other groups are competition at all,” Atala says “Our interest is really to get these technologies into patients. We consider the disease the competition.”

Spray-on skin One area of intense competition – or collaboration – is in spraying on new skin. AFIRM is funding several projects testing a product that uses a patient’s own skin cells, so that rejection is not an issue. Old-fashioned skin grafts may close a wound or a burn, but they don’t heal prettily.  ReCell is a product, more of a process really, that uses a small plug of a patient’s own skin, broken down into a soup using enzymes. Cells known as keratinocytes, which give skin its structure, and the melanocytes, which give color, are pulled out, mixed into a liquid suspension and then sprayed over the damaged area.

It’s a thin layer but the cells quickly multiply and, if the process is done right, form an even layer of new skin within days. The result is much more natural-looking than a graft.

Skin is easier to heal because it’s a relatively simple organ and on the
surface of the body. Limbs are more complicated – they are made up of bone, muscle, nerves, connective tissue and also skin.

Labs are taking a more traditional approach in trying to restore limbs, by transplanting them. But even there regenerative medicine can play a role.  This is where stem cell research comes in. Stem cells are the body’s master cells, and there are several kinds. People have stem cells known as adult stem cells all through their bodies, and they are already partly “educated” to become blood, muscle, bone or nerve cells.

These cells divide and multiply to produce muscle, bones and blood, and they also secrete compounds that help existing tissue and cells regenerate. Some of the projects on AFIRM’s wish list include calls for labs that can combine techniques used to build new body parts with the use of stem cells to help them generate and integrate with the rest of the body.

More powerful cells come from embryos that have barely begun to develop. An entire human body, the collection of muscle, bone, brain, blood, nerves and organs, all develops from the ball of just a few cells that forms days after fertilization. Each one of these cells, known as human embryonic stem cells, contains all the coding needed to make every cell type in the body.
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Helping the blind see In January, scientists at Advanced Cell Technology, a company based in Massachusetts, reported they had used some of these human embryonic stem cells to partially restore vision in two legally blind patients. First they “trained” the cells by incubating them in a nourishing soup of chemicals designed to make them differentiate into retinal cells. The stem cells, infused directly into the eye, regenerated cells known as retinal pigment epithelium cells.

One patient said she can thread needles again and another has been able to resume shopping on her own. ACT has since gotten permission to treat more patients with higher doses of the cells, now that they have at least been shown not to cause any harm. They’re going after patients with degenerative eye diseases such as age-related macular degeneration and Stargardt disease.  In both conditions the cells in the retina gradually die and patients go slowly and irreversibly blind.

They’ve treated 11 more patients, says ACT’s chief medical officer Dr.
Robert Lanza. “In all the patients we have been seeing a very real
biological signal,” Lanza told NBC News. “We have been very pleased because we are talking about very advanced stage patients, and there’s really no treatment for them.”

The experiments, known as clinical trials, are strictly regulated. In the
early stages of human testing, where ACT is now with stem cells, Stage 1 trials recruit only volunteers with advanced, severe disease who have little to lose. The tests are not aimed at showing whether the treatment works, but to ensure that it doesn’t do any harm. Showing efficacy is a big bonus.

“We are far enough along now that we can go into patients with better
vision. That is where we think we will see a very dramatic improvement,” said Lanza.

It doesn’t always go this well. ACT was neck and neck with another company called Geron to be the first to test human embryonic stem cells in people. Geron got there first in 2010, infusing the cells into a young man injured in a car accident, as well as three others. The hope was to regenerate their severed spinal cords. Again, these first patients were treated experimentally only to show the approach was safe and no one dared hope they’d actually improve. And none of them did. Geron dropped its stem cell program in November 2011, saying it wanted to focus on cancer drugs instead.

Lanza said the eyes are a great place to test new treatments because
researchers can literally look in there and see what’s happening. The
spine’s a little harder, but other labs are trying to help there, too.

‘I was afraid it would be a dream’ Ted Harada had a second infusion of stem cells last month. The 40-year-old former Fedex employee has Lou Gehrig’s disease, medically known as amyotrophic lateral sclerosis or ALS. It attacks nerves called motor neurons, gradually and inexorably paralyzing its victims. It’s always fatal as patients lose every bit of their ability to move, even to breathe. There’s no treatment and no cure.

Harada is hopeful enough to have tried the highly experimental treatment not once but twice. It’s painful – surgeons have to cut open his spine and infuse the stem cells right into his spinal fluid. But the last time Harada was treated, he went from walking with a cane to running with his kids – a transformation that made him an instant television celebrity.

“The results I saw were nothing short of miraculous,” says Harada, who lives in Georgia and who got treated at Emory University. “Within two weeks I started feeling my legs getting better. I was afraid it would be a dream and I would wake up and it would be gone again.”

And the effects did gradually wear off, Harada says. “All of a sudden I
started noticing fatigue in my legs,” he told NBC News. “I started noticing trembling, shaking in my legs. If you do a lot of weight lifting you know that rubbery feeling your legs get when they are spent?” That’s how he felt.

In August, Harada got a second infusion of stem cells, which are made by a company called Neuralstem, this time in his neck. “There were a lot of reasons to think this could not safely be done. The spinal cord itself is very precious real estate,” says Dr. Eva Feldman, a neurologist at the University of Michigan who is working on the ALS trial. “You are putting a needle into the spinal cord.”

Feldman admits that researchers on the trial don’t fully understand what the cells are doing. In animals, she says, they form new connections with damaged motor neuron cells in the spine. “They essentially nurture the sick cells into health,” she said. They secrete compounds known as growth factors that nourish the cells in the spinal cord. “They go in there and clean it up so that the whole environment looks less inflammatory … We are not letting the fact that we don’t fully understand how they work prevent us from using
them.”

Harada thinks he may already be feeling something but admits it might be wishful thinking. Trained nurses will measure his muscle strength to see if the new treatment has helped. “I am determined and relentless for them to utilize me as their guinea pig to figure out what is helping me and they can translate this into helping all the other cases of ALS,” says Harada. “I don’t want to provide false hope.”

That’s one thing that worries Dr. Paul Knoepfler, a professor of medicine at the University of California Davis. “There are a lot of clinics sprouting up, offering people stem cell treatment for anything that might be ailing you,” Knoepfler said in a telephone interview. “Some of these pop up in a strip mall, even. They might charge $20,000.”

Yet few, if any, have any real medical credibility, says Knoepfler. “For the most part, the science just isn’t there and yet people are talking about spending a whole chunk of their life savings and the clinic could be totally bogus,” he said.

“We are worried not only for specific patients, but it may tarnish the whole field generally if we have patients getting hurt or even killed by so-called stem cell treatments.”

(c) 2012 NBCNews.com Reprints

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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.