NFL Group, Company Teaming Up For Brain Drug Test

NFL Group, Company Teaming Up For Brain Drug Test

http://www.npr.org/templates/story/story.php?storyId=178784991

by The Associated Press

April 24, 2013 9:52 AM
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NEW YORK (AP) — A potential treatment for traumatic brain injuries may be tested in retired professional football players, who are the focus of concern over blows to the head.

Neuralstem, Inc., of Rockville, Md., said Wednesday it is working with the National Football League Alumni Association to study the feasibility of such a test, which would need government approval. It would involve a drug that’s now in an early human trial for treating depression. In animal studies, the drug appeared to stimulate creation of brain cells.

Concern has mounted about brain injuries and disease in former NFL players, driven in part by some high-profile suicides. Thousands of former players are suing the league and its teams, saying that for years the NFL did not do enough to protect players from concussions.

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.

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

 

 

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.

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.

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.”

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.

 

 

 

 

 

 

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.”

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).

Stem Cells Help Rats Recover Lower-Body Movement

Genetic Engineering & Biotechnology News |
www.genengnews.com

GENNewsHighlights <http://www.genengnews.com/gen-news-highlights/>

Sep 13, 2012

Stem Cells Help Rats Recover Lower-Body Movement

http://www.genengnews.com/gen-news-highlights/stem-cells-help-rats-recover-l
ower-body-movement/81247315/

A half-dozen paraplegic rats recovered movement in all lower joints after being transplanted with <http://www.genengnews.com/keyword/neuralstem/3100> Neuralstem’s <http://www.genengnews.com/keyword/nsi-566/8579>  NSI-566
spinal cord <http://www.genengnews.com/keyword/stem-cells/304>  stem cells-a result the company said could aid in treating human <http://www.genengnews.com/keyword/spinal-cord-injury/692>  spinal cord injury.

The six were among 12 rats experiencing lower-body paralysis after
undergoing complete spinal transections. The six were assessed over seven
weeks and compared to a control group that had not received transplants.
Neuralstem published results of its spinal cord stem cell transplant in the
journal Cell, in a paper titled “Long-Distance Growth and Connectivity of
Neural Stem Cells After Severe Spinal Cord Injury: Cell-Intrinsic Mechanisms
Overcome Spinal Inhibition.”

According to the study, rats treated with NSI-566 showed significant
locomotor recovery, with most (57%) of the grafted cells turned into
neurons. Also significant, according to the company, was the number of axons
that emerged, extending over 17 spinal segments both above and below the
point of spinal cord lesion. The axons expressed synaptic proteins in the
host gray matter, suggesting they made synaptic contact with host spinal
neurons.

“The fact that these cells induce regeneration of axons and partial recovery
of motor function makes them relevant for testing for the treatment of human
spinal cord injury,” Karl Johe, Ph.D., Neuralstem’s chairman and CSO, said
in a statement.

According to the paper, retransecting the spinal cord immediately above the
graft abolished functional gain, a finding that Neuralstem said indicated
that the regeneration of host axons into the human stem cell graft was
responsible for the functional recovery.

Neuralstem has submitted an application to the FDA for a trial to treat
chronic spinal cord injury with NSI-566. The cells were used in a recently
completed Phase I clinical trial for amyotrophic lateral sclerosis (ALS or
Lou Gehrig’s disease).

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