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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.

Keep in mind following things while overnight generic viagra buying a drug or medicine from online pharmacy shop. Some men cialis pill cost are incapable of holding on for more time due to stress and mental depressions. You canadian viagra samples can never trust anyone but yourself in this world. online cialis pharmacy So what options are available for these courses? Why Take Adult Drivers Ed Online Adult drivers education courses online. Neuralstem shares on the New York Stock Exchange, which were trading at $1.18 on Friday, spiked 15.3 percent early Monday to $1.36, before falling to $1.28 later in the day.

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.”

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* Don Wright Interview by Dr. Sanjay Gupta

KOSIK: And every week, Dr. Sanjay Gupta brings us incredible stories of recovery and survival from around the world. In today’s “Human Factor,” our chief medical correspondent reports on a 71-year-old who’s continued his dream of running marathons while fighting a dangerous form of cancer, one where patients are rarely cured.

http://www.cnn.com/video/#/video/health/2013/01/09/human-factor-don-wright.cnn

SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT: Don Wright’s career spanned engineering, being a company vice president, and the law. At age 62, he discovered a new passion — marathons. Nine year ago, days after running his first 26-mile race, he got some devastating news.

DON WRIGHT, MARATHON RUNNER/CANCER PATIENT: I had gone to the doctor a couple of times for pain in my back. It was multiple myeloma.

GUPTA: This is a cancer of the blood where the white blood cells invade the bone marrow causing pain, usually in the back or the ribs. Patients are rarely cured. But Wright refused to let that slow him down, even qualifying for the Boston marathon.

WRIGHT: We got this devastating diagnosis, and we just — my family and I, we just kept on going. You know, there wasn’t any reason to stop and be sorry, you know. We kept running marathons.

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WRIGHT: It feels wonderful, I’ll tell you. A philosophy of life that I have is live one day at a time and make it a masterpiece, and that was a masterpiece.

GUPTA: Wright wasn’t sure he could fulfill his dream because the median survival for his cancer is just five years. Prognosis does vary depending on age and stage of the disease. He’s had a number of treatments that have failed. But for the last four-and-a-half years, Wright’s taken an experimental drug, one pill at night, that’s worked. It’s kept the cancer at bay.

WRIGHT: It doesn’t cure the cancer, but it keeps it stable so it’s not hurting me. And I can still run. And I can still enjoy life, and I’m riding that for all it’s worth.

GUPTA: His advice to others facing what seemed like insurmountable odds, take charge of your own destiny and never give up hope.

Dr. Sanjay Gupta, CNN, reporting.

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* A Minnesota man who has incurable cancer hits a big milestone

http://www.kvue.com/news/182916671.html

by WCNC

kvue.com

Posted on December 10, 2012 at 8:43 PM
Updated Tuesday, Dec 11 at 7:18 AM

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A Minnesota man who has incurable cancer hits a big milestone.

Seventy-one-year-old Don Wright reached his goal of running marathons in all 50 states. He hit 50 this Sunday in Honolulu.

“My family and I have been running marathons in every state, and that’s been our goal, and we’ve run marathons now in 49 of the 50 states,” Wright said before the race on Sunday, “The diagnosis for my cancer was a three to five-year median survival. It feels like when I’m running along in a marathon, I’m just sticking my finger right in that cancer’s eye.”

Wright has a type of blood cancer.

He says he’s been able to control his battle thanks to a drug that’s being used in clinical trials.

And, he says he’ll keep running as long as he can.

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* Cancer survivor runs his 50th marathon in the 50th state

http://www.hawaiinewsnow.com/story/20292980/cancer-survivor-runs-his-50th-marathon-in-the-50th-state

Cancer survivor runs his 50th marathon in the 50th state

Posted: Dec 07, 2012 10:42 PM EST Updated: Dec 08, 2012 1:43 AM EST

By Teri Okita – bio | email

HONOLULU (HawaiiNewsNow) –

Come Sunday morning, organizers are expecting more than 31,000 runners at the Honolulu marathon. In that crowd, a Minnesota man will, appropriately, be running his 50th marathon in the 50th state.

But Hawaii News Now found out: there’s much more to his story.

Don Wright has had plenty of practice crossing the finish line. This Sunday, he’ll have run a 26.2 mile marathon in every state in the nation.

“That’s pretty. I can’t wait ’til I’m running under that!” says Wright – as he looks at the finish line sign that’s not even hung up yet.

At age 71, not many people can say they’ve finished one marathon – let alone 50. It’s pretty impressive for a guy who just picked up running decade ago.

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Age is the least of his challenges. The St. Paul-area man was diagnosed with multiple myeloma – a blood cancer that affects cells in bone marrow. He was given about five years to live – that was nine years ago.

Running became his path to survival.

“It gives me a chance to make a point that people who have cancer can still have active, vital lives,” he says.

When Wright crosses the finish line on Sunday, he figures he will have logged 12,000, maybe 13,000, miles training and running these marathons.

Do the math. That’s like running from one coast to another – Los Angeles to New York – almost five times! His last marathon was just five weeks ago, and in 2011, he ran more than one marathon a month.

“He’s a runner, not a myeloma victim,” says his wife, 73 year old, Ardis. The Wrights and their daughter often race with together.

He’s stabilized on an investigative cancer drug called pomalidomide and needs no infusions or transplants. “We’re free because all he has is that little pill bottle, and he takes one pill every night and we can go,” says Ardis.

And go they do – successfully on the run from cancer.

Copyright 2012 Hawaii News Now. All rights reserved.

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* Man with incurable cancer looks to complete quest to run marathons in all 50 states

Man with incurable cancer looks to complete quest to run marathons in all 50 states

Reported by: Olena Heu

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Click here to read the full article and see the video

One of the participants in Sunday’s Honolulu Marathon has overcome many obstacles to get here. The Minnesota resident was diagnosed with an incurable cancer.

Don Wright, 71, says he loves to run.

“I feel like I am floating past the scenery and just gliding along watching it go by,” Wright said.

Nearly 10 years ago, just days after Don’s first marathon, he was diagnosed with myeloma, which is a cancer of the blood.

“The diagnosis for my cancer was a three-to-five year median survival,” Wright said.

Inspired not to let the disease keep him down, the Minnesota resident decided to keep running.

“My family and I have been running marathons in every state. That’s been our goal and now we’ve run marathons in 49 of the 50 states,” Wright said.

When he completes the Honolulu Marathon on Sunday Don will achieve his goal of running 50 marathons in all 50 states…in the 50th state.

“It feels like when I am running along in a marathon like I have just stuck my finger right in that cancer’s eye,” Wright said.

Don runs with the hope of raising funds and awareness for The Tackle Cancer Foundation and has been able to control his battle with cancer thanks to a drug currently being used in clinical trials for his condition.

“That has kept it stable for five years and I actually feel very good,” Wright said.

Will this be his last marathon?

“This will never, no, no I will keep running marathons until I can’t, and that’s hopefully a long way off,” Wright said.

Click HERE to view Wright’s running blog.

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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.”

Posted on

* 50-state marathon runner stops in N.M.

50-state marathon runner stops in N.M.

http://www.koat.com/news/new-mexico/albuquerque/Marathon-Man/-/9153728/17072524/-/4xbrdv/-/index.html

Despite incurable cancer, man runs in dozens of marathons
Published 10:02 AM MDT Oct 21, 2012
ALBUQUERQUE, N.M. –
A Minnesota man diagnosed with an incurable form of cancer is on the run of his life as tries to run 50 marathons in 50 states.

Action 7 News reporter Tanya Mendis spoke with Don Wright on Sunday about his drive to keep running no matter what.

Wright said he was diagnosed with myeloma at 62. Nine years later, the 71-year-old has run marathons in 48 states.

Wright said he hopes to make New Mexico his 49th state.

“When I run, to be honest, I feel like I’m poking that cancer right in the eye,” Wright said.

So far he has run 69 marathons in 48 states.
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“I’d like people to be healthy and think healthy and if I’m an inspiration, that’s all the better,” Wright said.

He said he wouldn’t been able to run more than a few miles, if not for a special trial cancer drug he began four years ago.

“Which for me has turned out to be a miracle drug. It keeps the cancer stable, it doesn’t cure the cancer but it keeps it at a level where the cancer doesn’t hurt me,” Wright said.

He said he might not ever fully escape his cancer but he’s giving it the race of his life.

“The cancer numbers went down to about one-third of what they were to where it’s safe,” Wright said.

Wright did admit that he’s a little old to be running five or six days a week but he doesn’t plan to stop running marathons.

Wright will take part in the Duke City Marathon on Monday.
He said he plans on running his 50th and final state in Hawaii in December.

After that, he might try Canada.

Posted on

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).