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Patient, doctors encouraged by ALS trial

By Miriam Falco, CNN

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http://www.cnn.com/2011/09/28/health/early-als-trial-results-encouraging/index.html?hpt=he_c2

(CNN) — A little more than two years ago, Ted Harada felt his left leg weakening, and he found himself quickly running out of breath. Doctors first thought he had asthma, but in May 2010 they told him he probably had ALS, or Lou Gehrig’s disease.

In August 2010, doctors confirmed Harada, then 38, had the fatal disease, and he knew it was progressing.

“Every month they [doctors] could see deterioration,” Harada said.

ALS patients lose muscle function in the lungs until they can no longer breathe. Most people with ALS die from respiratory failure within three to five years of first symptoms, according to the National Institute of Health. The disease causes nerves to wither and the lungs to stop working. About 10% of ALS patients live 10 years or longer.

Harada joined a clinical trial at Emory University in Atlanta, where doctors were injecting neural stem cells — the precursors to nerve cells — into the lower spinal cord of ALS patients.

Before the procedure, Harada walked with a cane and would get winded just by walking to the mailbox. He had to quit his job as a manager for a shredding company. He was so tired he couldn’t play with his three children. He was too weak to pick up his youngest child. He couldn’t even open a Ziploc bag.

Harada hoped the treatment would help, but he didn’t expect it to. However, two weeks after getting the stem cell injections in March, he says he started to feel better.

“It’s been nothing short of miraculous,” he says. “I cannot begin to explain the difference it has made.”

He hasn’t touched his cane in months, he says, and his breathing has improved.

“I was afraid I would wake up and the improvements would be gone,” Harada said.

Dr. Jonathan Glass, who is overseeing the clinical trial at Emory, and Dr. Nicholas Boulis, who invented the surgical procedure used to inject the stem cells, explained to patients that participation in the trial would not cure or even benefit them personally, but it would help doctors learn more about how to treat ALS in the future.

The first phase of any clinical trial is to prove that a treatment won’t injure patients, not that the treatment works, said Dr. Eva Feldman, who designed the clinical trial at Emory.

The first part of the ALS study, sponsored by the Maryland-based biotech company Neuralstem, is designed to show that the surgical procedure to inject the stem cells into the spine is safe, and that the patients’ bodies won’t reject them. According to researchers, the cells did not harm any of the 12 patients in the Emory study, nor did they accelerate the progression of their ALS.

“I need to temper my excitement because it’s a very small patient population,” said Feldman, president of the American Neurological Association. But the facts are not discouraging. She presented early data from the study Monday at the neurological group’s annual meeting in San Diego.

“We have cautious optimism that a few of the patients may have slowed in their progression of lower extremity weakness, and one patient may have improved,” her report said.

Of the 12 patients in the trial, two have died.

John Cornick’s disease had progressed further than Harada’s by the time he received the stem cell injections in 2010. He was already in a wheelchair, and he knew participating in the clinical trial wouldn’t cure him. But he told CNN in April 2010 that the only way doctors were going to figure out how to cure ALS was to have people willing to participate in clinical trials.

“For me it just seemed like the right thing to do,” he said.

Cornick died of ALS in May. Another patient in the study, a 39-year old man, died of a heart attack.

Feldman said the conditions of eight of the remaining 10 patients have not changed. Based on these results, she and her team in Georgia are asking the Food and Drug Administration to allow them to move to the next part of the trial: Injecting stem cells higher on the spine – into the cervical spinal cord, which is in the neck.

Harada is optimistic that research like this will give other patients hope and lead to treatments in the future. He realizes he hasn’t been cured, but it’s like his clock has been set back, he says. He feels like he did when symptoms first started to appear in 2009.

“I know I still have ALS. I am so grateful for this gift regardless of how long or short it lasts,” he said.

“I can go through most days without thinking I have ALS.”

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Stem cell treatment goes from lab to operating room

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By Miriam Falco, CNN Medical News Managing Editor
May 4, 2010 8:10 a.m. EDT

http://www.cnn.com/2010/HEALTH/05/04/stem.cells.lou.gehrigs/index.html

Atlanta, Georgia — Imagine having your back cut open, part of your spine removed, a stabilizing device that resembles a mini oil rig mounted on your back, the outer membrane of your spinal cord sliced open and experimental stem cells injected into it — all for the advancement of science because it’s not expected to benefit you.

John Cornick, 51, did just that earlier this month as part of a groundbreaking clinical trial.

Almost a year ago, Cornick was told he had ALS — better known as Lou Gehrig’s disease. The diagnosis left him “fairly devastated,” he says.

He knew the prospects were grim because there is no cure.

But John wasn’t giving up so quickly, nor was his wife, Gina.

“I knew he was a fighter from the beginning and he really wanted to do something,” Gina Cornick says. She found information about a clinical trial on online and immediately signed him up, even though she had no idea where it was being held.

ALS destroys the nerve cells in the brain and spine which control muscle movement. When the brain can no longer tell muscles to move, they eventually die, depriving the patient of the ability to move arms and legs and eventually breathe.

The goal of this phase 1 trial is to determine whether fetal stem cells can safely be injected into the spinal cord. Ultimately, researchers hope to show that these cells may slow or halt the progression of the fatal disease.

But for now, the only goal is establishing safety.

Clinical trial

The Cornicks live in North Carolina, just a few hours from Atlanta, Georgia’s Emory University, the site of the trial. It is the first FDA-approved clinical trial to inject fetal stem cells directly into the spinal cord of an adult.

Dr. Jonathan Glass, director of Emory’s ALS center, is overseeing the trial. Cornick and two previous patients in the trial are heroes, says Glass, because at this point, the trial will likely produce only information, not results.

“In reality what do these patients have? Time, families and their life and we’re putting all of these at risk,” says Glass.

Dr. Lucie Bruijn, science director of the ALS Association, says the progress being made in this clinical trial is exciting. “We’ve been able to move it forward … from animal testing now into actual patients.” The treatment had not been tried in humans before.

Glass hopes this trial will lead to a new form of treatment for people with ALS. “We’re testing multiple things: We’re testing the safety of the surgery; we’re testing the cells; we’re testing immunosuppressants[because scientists do not know whether the body will reject the cells].” They are also testing how well Cornick handles this major surgical procedure, says Glass.

“After we’re finished with the first 12 or 18 patients we will know whether this is surgery that patients can tolerate.”

As he was prepped for surgery, Cornick was hopeful but realistic. “Well, of course you’d like to get up and walk … but I know that’s not going to happen.”

Stem cells

The stem cells used in the surgery are shipped overnight from Maryland, where Neuralstem, the company funding the trial, is based. The stem cells’ source is donated tissue from the spinal cord of an 8-week old aborted fetus, which was donated to the company. The company has developed a method that enables growth of millions of stem cells from this single source of human nerve stem cells.

Before the surgery can begin, a technician at Emory has to verify that a majority of stem cells made it to Atlanta alive. At least 70 percent have to be viable. In this case three samples under the microscope showed 85 percent of the cells arrived alive.

Lead researcher Dr. Eva Feldman, a neurologist at the University of Michigan, designed the trial just four years ago. After a lot of animal testing, her team determined that using fetal nerve stems rather than human embryonic or adult stem cells (such as bone marrow stem cells) was most effective, she says.

Stem cells have the ability to turn into different cells in the body. However, human embryonic stem cells, which come from 4- or 5-day-old embryos, also been found to sometimes turn into cancer cells. Fetal stem cells, such as those used in this trial, are a few weeks older and have already taken on a specific identity — in this case nerve cells.

Feldman says the fetal stem cells used in this trial did not become any of the unwanted cell types. “That’s very, very important,” she says.

Surgery

Animal testing also proved very useful when it came to figuring out how to actually inject the stem cells. Emory University’s neurosurgeon Dr. Nicholas Boulis invented the device that holds the needle that injects the stem cells. The goal is to inject the cells without injuring the spine and causing even more paralysis. He practiced on 100 pigs before attempting the procedure on a human.

Boulis says it’s critical that the injection be done in a very slow and controlled way.

“If you inject quickly, you’re going to create pressure at the head of the needle and that can cause damage,” Boulis says. That pressure can also inflate an area in the spinal cord which could cause the stem cells to seep back out of the cord when the needle is pulled out, he says. “So by pumping [cells] in slowly you have more security that you are not going to have reflux and you’re not going to have damage.”

Dr. Jeffrey Rothstein, who heads the ALS research center at Johns Hopkins University and is not connected to this trial, said work on this method is a big achievement. “This is purely about how to surgically deliver cellular therapy to spinal cord,” he says. “It’s never been done before.”

After the spinal cord was exposed, the injections began. Cornick got five — each one contains about 100,000 stem cells.

The four-and-a-half hour surgery went smoothly, Boulis, says. “There were no surprises.”

Post-surgery

A day after surgery, Cornick was lying flat in a hospital bed, chatting and laughing with some friends from North Carolina.

One week after surgery, he says he felt amazingly well and was still hopeful the cells would do some good for him.

Two weeks later Cornick’s stitches were removed and he was able to drive home. But he will be making frequent visits back to Atlanta as Glass and his team continue to monitor him.

Neuralstem’s Chief Scientific Officer Karl Johe says after the trial’s safety board reviews all existing data, including Cornick’s results, a fourth patient can be treated with the stem cells.

“Patients Four, Five and Six will receive twice as many [stem cell] injections,” Johe says. They will get five more injections on the other side of the spinal cord compared with Cornicks’s surgery.

Cornick expects the researchers will follow his progress for a long time. He says he understands the need for people to be willing to participate in experimental research like this.

“For me it just seemed like the right thing to do. I almost felt I had an obligation to do this,” he says. “To help other people and myself.”

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UM researcher to test stem cell treatment for Alzheimer’s

8:00 pm, May 2, 2010

Results from ALS trials spur optimism
By Ryan Beene And Tom Henderson

http://www.crainsdetroit.com/article/20100502/FREE/305029968/1069

Buoyed by early results of stem cell-based trials on patients with Lou Gehrig’s disease, Eva Feldman, M.D., co-director of the A. Alfred Taubman Medical Research Institute at the University of Michigan Medical School, is now taking aim at a far bigger target: Alzheimer’s disease.

In late April, Feldman began raising $1.5 million from private donors to fund animal trials for a stem cell-based treatment of Alzheimer’s, a progressive degenerative disease that severely impacts brain function and afflicts more than 5.3 million people in the U.S. It is the seventh-leading cause of death in the nation.

Animal trials are required before Feldman can begin Phase I U.S. Food and Drug Administration trials for Alzheimer’s on humans. Tests on both safety and efficacy are done first on small rodents and then, if successful, on larger mammals.

Feldman said she hopes to apply for approval in 2013 for human Alzheimer’s trials and begin them in 2014.

The investigation into an Alzheimer’s treatment piggybacks on current Phase I human trials for patients with Lou Gehrig’s disease led by Feldman that are under way at Emory University Hospital in Atlanta.

The trials test the safety of injecting neural progenitor cells, essentially stem cells that have developed beyond the embryonic phase and are predisposed to becoming nerve cells, into the spinal cords of patients with Lou Gehrig’s disease.

Feldman will continue to serve as principal investigator on that trial — the first FDA-approved trial using stem cells on Lou Gehrig’s patients in the U.S. — as she and her team begin work on Alzheimer’s trials.

Eighteen Lou Gehrig’s patients will be tested in all. The disease, known formally as amyotrophic lateral sclerosis, or ALS, afflicts as many as 30,000 patients in the U.S.

Feldman sped up her timetable for taking on Alzheimer’s after seeing promising early results with three Lou Gehrig’s patients. The first patient was injected on Jan. 19. The third operation, on April 14, was filmed by CNN.

Feldman said she is prohibited from discussing whether patients report such results as increases in strength or sensation. But there have been no ill effects from the three surgeries.

Each patient is injected at five spots on the spinal cord, with about 100,000 cells per injection.

Feldman said she is excited about expanding stem cell trials to Alzheimer’s because of the far larger pool of would-be patients.

The nerves and tissues also are narrowed due to fast delivery cialis http://foea.org/wp-content/uploads/2014/12/FEA-2012-ANNUAL-REPORT-PDF.pdf growing age. It is a serious health concern, which can ruin your generic cialis Visit Website sexual life. 2. However, almost viagra free pill all of them have some limitation of recurrence and certain side effects to affect the female fertility to some degree. By reducing acid production in stomach this not only helps cialis generika 20mg in enlargement of the penis but also treats for lesser ejections and other related erectile issues. “Alzheimer’s is going to be easier to do than ALS,” said Feldman.

She said that the brain can be injected with far more stem cells than the spinal cord, promising greater and faster benefits, and she said the surgery is far less invasive. Instead of needing to remove bone from the back, a tiny hole is cut into the skull in a relatively safe, easy procedure.

The transition from Lou Gehrig’s to Alzheimer’s disease is a natural one because the treatment potentially addresses the same problem. The neural progenitor stem cells work by surrounding specific large nerve cells that are sick and halting further degeneration caused by the disease, Feldman said.

“In the spinal cord, these nerve cells produce the nerve tissue fibers that extend through the muscles of our body, and in the brain, the same type of nerve cell facilitates thinking processes,” Feldman said.

“The kind of stem cells we’re using have a particular proclivity to rescue cholinergic neurons, and it’s cholinergic neurons that degenerate and become diseased in Lou Gehrig’s disease and Alzheimer’s disease.”

The surgeon in the current trials is Dr. Nicholas Boulis, an associate professor at Emory University who was formerly a fellow in Feldman’s research lab at UM.

Boulis specializes in movement disorders, such as Parkinson’s and Huntington’s diseases, and performs about 300 operations a year. He also heads a gene-therapy research lab and is involved in a project that aims to use gene therapy to treat Alzheimer’s.

Boulis said he hopes, if the FDA approves human tests, to do Feldman’s Phase I Alzheimer’s operations, too.

“If Eva thinks we can make progress, I’m her man,” he said.

The Phase I Lou Gehrig’s disease trials are scheduled to finish by the end of June 2011. If they go as hoped, Phase II trials, which assess efficacy, can begin as early as January 2012. Feldman said Phase II trials could add the UM hospital as a test site in addition to Emory.

Investigating a treatment for Alzheimer’s using stem cells is an “interesting approach” and a logical next step to investigate, said Dr. Ken Maiese, professor in the departments of neurology and anatomy and cell biology at Wayne State University Medical School.

“There’s really no good treatment for Alzheimer’s, although there are many trials going on” for drugs that deal with chemicals in the brain related to Alzheimer’s, Maiese said.

But those treat the symptoms, not the underlying issue of rapid brain cell degeneration that is a hallmark of Alzheimer’s.

Maiese cautioned that the science behind a stem cell treatment still has a long way to go, as in any treatment. Going from animal to human trials involves many unknowns.

Feldman said she recently took on a new, young ALS patient, to whom she could, for the first time in her 20 years of treating patients at UM, offer some encouraging words about future treatments.

“For 20 years, there has been little hope I could offer patients. Now there is truly tangible hope. We are truly beginning to try a therapy that can allow us to help halt the progress of this dangerous disease,” she said.

“Patients ask me “what will the future hold?’ I told my new patient, things are extremely hopeful now. The future is very bright. And not just with ALS or Alzheimer’s, but with Parkinson’s and Huntington’s, too.”

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Stem Cell Medical Breakthrough?


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CNN’s Dr. Sanjay Gupta reports on a new stem cell clinical trial that is making history.

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Stream from CNN Here

http://www.cnn.com/video/#/video/health/2010/04/30/gupta.medical.breakthrough.cnn?iref=allsearch

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Aastrom’s Stem Cells Knit Hard-to-Heal Bone Breaks

Aastrom’s Stem Cells Knit Hard-to-Heal Bone Breaks (Update1)

By Rob Waters

Oct. 18 (Bloomberg) — Aastrom Biosciences Inc. said its stem cell treatment repaired fractures in 91 percent of patients with previously hard-to-heal breaks in the long bones of their thighs, shins or arms.

The study tested stem cells developed by Aastrom by inserting them during surgery into the fracture sites of 33 patients with severe bone breaks that had previously failed to join from standard treatments. A year later, the fractures of 30 of the patients had healed, the Ann Arbor, Michigan-based company reported today at a medical meeting in Boston.

“We are treating patients that have not healed in the past and are unlikely to heal in the future with normal procedures,” said Elmar Burchardt, the company’s vice president of medical affairs, in a telephone interview. “It’s a completely new approach for bone treatment and tissue regeneration with the idea of restoring its original architecture.”

Aastrom, one of several U.S. companies working to bring stem cell-based treatments to market, has created a technique for expanding and purifying patients’ own stem cells as a therapy. The company is testing its approach in several orthopedic uses as well as in a disease that restricts blood circulation in limbs. It’s also developing treatments for patients with heart disease and spinal cord injuries.

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The company is furthest along in testing its cells to treat a rare condition called osteonecrosis that damages bone in the hips and other places because of a poor blood supply. The company is now recruiting 120 osteonecrosis patients for the final stage of testing normally required for regulatory approval. It could seek clearance from the U.S. Food and drug Administration as early as 2010, Burchardt said.

Aastrom rose 4 cents to $1.20 at 6:02 p.m. New York time in extended trading. The stock gained 2 cents to $1.16 at 4:20 p.m. in regular Nasdaq Stock Market composite trading.

The 30 bone-fracture patients who were deemed by the company to have healed all had bone scans that showed “multiple contact points” between pieces of bone that were formerly fragmented, Burchardt said. The patients’ limbs now “are fully weight- bearing and have full range of motion,” he said.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .

 

Posted on

Stem Cell Firms Struggle for Financing

Sep 1 2007 (Vol. 27, No. 15)

Stem Cell Firms Struggle for Financing

Lack of Proper Information, Over-regulation, and Confusion over IP Incites VC Hesitance

Gail Dutton

Venture capitalists say that they are very interested in stem cells but not enough to start funding stem cell companies. Right now, the business case for investment isn’t there. “Great science doesn’t equal great business,” points out Gregory A. Bonfiglio, managing director at Proteus Venture Partners.

Financiers, just past the stinging losses of the dot-com heyday, need a stronger business case nowadays for investments. In fact, it’s not just stem cell companies that are suffering. Venture capital in general is down from more than $100 billion in 2000 to less than $20 billion in 2006, Bonfiglio points out. Investments in all forms of regenerative medicine accounted for about $190 million, or less than 2% of total healthcare funding in 2005.

“VC’s goals beyond a minimum fivefold return are to get a company through two rounds of financing and generate human proof of concept—generally Phase IIA data—or build a broad platform with a strong intellectual property position that could create a lot of pipeline opportunities,” according to Doug Fambrough, Ph.D., partner, Oxford Bioscience Partners.

“I don’t think that exists in the stem cell world,” he says. “People don’t see the broad intellectual property protection that gives companies the freedom to operate and the ability to exclude. Therefore, I wouldn’t invest in a platform but in therapeutic opportunities.”

Stem cell based drugs, Dr. Fambrough adds, must have large potential markets, significant benefits compared to competitors, and the ability to be commercially supplied. A company needs to have its core research completed with proof of concept as well as a strong management team and a sturdy intellectual property position, Bonfiglio continues. Because so many of these ingredients are not yet apparent, Dr. Fambrough says he’s only interested in providing second-round financing.

Literature of Disinformation

There’s a certain bitterness expressed by stem cell company execs toward venture capitalists. The perception is that venture capitalists are risk averse, more so than even microcaps, institutional investors, or hedge funds, according to Richard Garr, J.D., CEO of Neuralstem (www.neuralstem.com). Another exec even went as far as to say that venture capitalists were “brain dead” for not embracing a technology that has the potential to become more important than recombinant therapy.

“Venture capitalists don’t understand the science at all, and they can’t go to their usual suspects for guidance, because they either are aligned with somebody’s technology,” Garr comments, or they are too far removed from the field to comment intelligently. “The private sector, in many areas, is way ahead of the academic sector in the stem cell world.”

Research has been conducted on embryonic stem cells for slightly more than a decade but has been sharply limited in many nations. “A lot more is known about adult stem cells,” Bonfiglio says, as they have been the object of research for the past 40 or more years. “But, they are limited in scope. Embryonic stem cells address any disease in the body. The problem is finding and isolating them.”

Tom Okarma, president and CEO of Geron (www.geron.com), points to the “literature of disinformation.” Some researchers, “are furious about the fact that original stem cell lines are officially fundable and they are not getting funded,” he elaborates. Others criticize the quality of the original lines, muddling the issue for scientists and financiers alike.

According to Okarma, research papers suggest that the original stem cell lines approved for NIH research by President Bush in 2001 were contaminated and thus unfit for clinical trials. Yet, Geron is using two of those original lines successfully. The difference, he says, is that Geron treated the cells under GMP conditions. “The scientific community generally doesn’t understand that. Most academics have no experience producing or qualifying cells for human therapy.”

There’s another fallacy, too. A big question is whether human embryonic stem cells are scalable. Dr. Fambrough thinks not, presenting a repugnant specter of harvesting cells from fetal cadavers. Geron’s Okarma bristles at the notion, dismissing it as a gross inaccuracy. “We’ve done hundreds and hundreds of population-doubling procedures for some of our lines without any changes in the cells. Our lines are 100 percent scalable, are Bush-approved, and two of them are fully qualified for human use.”

No Consensus on IP Status

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Impact of U.S. Regulation

The myriad of conflicts within the field is the direct result of the 2001 restriction on stem cell lines approved for federally funded research in the U.S., according to Okarma. “We need more science,” Okarma insists. “The field is in a state of confusion.” Since 2001, he says, the NIH has invested $2.8 billion in adult stem cell research and only $130 million on embryonic stem cell work. Consequently, individual companies have done the heavy lifting.

Firms are thus focusing on adult stem cells, effectively lessening the body of knowledge on their embryonic counterparts and the stem cell field in general. The latter will result in longer approval processes as lead candidates approach the FDA and other regulatory bodies in preparation for clinical trials.

To replace those peer-reviewed studies, companies will have to perform additional large investigations themselves. For example, big Phase III evaluations will be needed to correlate surrogate endpoints with clinical improvement. Such trials are on a scale that only big pharma can bear, if they are willing to buy in, Dr. Fambrough says. So, to attract venture capital, a lot of elements need to come together, including a clinical development path a small company can handle, he adds.

“The key to attracting funding is to be close to the clinic with a good IP position,” Garr emphasizes, “and it would be very difficult now to come up with something close to the clinic that is not already in one of the existing companys’ areas.”

Those who believe you have to make individualized therapies for each patient won’t get funded because that approach isn’t scalable, Okarma emphasizes. Yet, Tengion (www.tengion.com), a tissue engineering company founded in 2003, raised $50 million in a Series B financing in June 2006 for a total of $112 million. It began Phase II trials for a bladder construct last January using a patient’s progenitor cells that aren’t yet fully differentiated.

Financial Options

The financing plan for Neuralstem, according to Garr, has been very simple. “Avoid the VCs.” Founded in 1996, it has relied on private placements and grant work to advance its work in fetal-derived stem cells. Currently, Neuralstem is in the process of migrating from the OTC Bulletin Board to the American Stock Exchange and expects to begin its first human trial in 2008.

Garr says there’s an elitist attitude among VC firms. “If you are not hooked up with Harvard or Stanford, they don’t take you seriously.” That’s true for the NIH, too, Bonfiglio adds. “The NIH is focused more on stature within the academic community. DARPA, however, is more interested in the technology.”

Funding prospects may improve, although it will take some time. The prevailing sentiment is that the next U.S. presidential administration will lift the ban on stem cell research. “The political drive seems to be there,” Dr. Fambrough says. Garr predicts that the U.S. Senate has enough votes to overturn the ban, but the U.S. House of Representatives will hold firm. Yet, he says, “It’s a question of when, not if.” He also says that there is the strong possibility that a bill overturning the ban will be attached this year to must-sign legislation, like the Department of Health and Human Services funding bill.

Exit Strategies

As firms enter Phase II trials, they are beginning to consider their next financial moves. Traditionally, when Phase II is completed, venture capitalists are ready to exit. As one strategy, Bonfiglio mentions mergers as a potentially attractive option, as they provide cash upfront and stock in a liquid company. “Average merger and acquisition returns are now 2.5 times higher than IPOs. Other options include a reverse merger with a public shell company or a private investment in a public entity.”

Listing the stock on the London Stock Exchanges’ Alternative Investment Market (AIM) is another opportunity, he says. Admission to AIM takes three to six months and is less regulated than NASDAQ, as Sarbanes-Oxley and SEC regulations are not involved. AIM also has smaller costs and fees, a lower threshold for listing, and a broad international mix of companies.

When it comes to funding, a good location indirectly helps. Naturally, companies in locations with a strong pharmaceutical industry, human capital, and support infrastructure have an advantage. Beyond that, some countries like Singapore and some U.S. states like California are funding stem cell initiatives.

If the other infrastructure is lacking, however, the funding can be largely irrelevant in producing viable results. “The money hasn’t really materialized,” Fambrough concludes.

Posted on

Aastrom Will Test Stem Cells in Patients With Diseased Limbs

Aastrom Will Test Stem Cells in Patients With Diseased Limbs

By Rob Waters

April 30 (Bloomberg) — Aastrom Biosciences Inc. will begin a clinical study using people’s own stem cells to improve the poor blood circulation that has damaged their legs, a condition known as critical limb ischemia.

U.S. regulators have given the company permission to begin trials, based on results from a small pilot study in Germany that suggested the treatment was safe, said Elmar Burchardt, vice president of medical affairs at the Ann Arbor, Michigan, company.

About 900,000 Americans suffer from limb ischemia, which can impair the body’s ability to heal wounds and leads to 100,000 amputations each year, according to the U.S. Centers for Disease Control and Prevention. The condition is the most serious form of peripheral artery disease, which occurs when blocked arteries impede the flow of blood to the legs. It affects about 10 million people in the U.S.

“These are critically ill patients,” said Burchardt, in a phone interview. “Their wounds are not closing and they have a very high risk of having to undergo an amputation.”

The trial will include 120 patients at 20 centers around the U.S. Doctors will take bone marrow cells from the patient’s hips and send them to Aastrom, which will process them to increase the number of stem cells while keeping them from turning into other cell types.

Bone marrow is one of the places in the body where so- called adult stem cells are found. These cells have the ability to turn into cartilage, bone and blood and are part of the body’s own system for repairing injury and disease.

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In half the patients, the amplified cells will then be injected at multiple points in their legs, above and below the knee. The other patients will go through the same procedure but won’t get real stem cells.

“The idea is you cover a large area with injections, stimulate vessel growth and improve blood flow in the limb,” Burchardt said.

Eight patients went through this procedure in the German study, Burchardt said. About half have passed the one-year mark, and all of those showed signs that their wounds were healing. None of the eight patients experienced any adverse effects, he said.

If successful, results from the larger U.S. study “may apply to all ischemic diseases,” said Anthony Comerota, director of the Jobst Vascular Center in Toledo, Ohio, in a statement e-mailed by Aastrom. He is the study’s lead investigator.

The study could thus help validate the idea of using stem cells to treat heart disease. The first results from the new study won’t be available until patients have been treated for a year.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .

Last Updated: April 30, 2007 07:01 EDT

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Stem cells delay paralyzing disease

Stem cells delay paralyzing disease
Mon Oct 16, 2006 3:08 PM ET

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) – Human fetal stem cells can graft onto the spines of rats and delay some of the paralyzing symptoms of motor neuron disease, commonly known as Lou Gehrig’s disease, U.S. researchers reported on Monday.

The new cells were resistant to the disease, also known as amyotrophic lateral sclerosis or ALS, the researchers said.

A company associated with the researchers is incubating batches of the human cells, taken from an aborted fetus, and hopes to market them as a treatment for several sorts of paralyzing conditions.

“We were extremely surprised to see that the grafted stem cells were not negatively affected by the degenerating cells around them, as many feared introducing healthy cells into a diseased environment would only kill them,” said Dr. Vassilis Koliatsos of Johns Hopkins University, who helped lead the study.

The researchers, who published their findings in the journal Transplantation, used specially bred rats that always develop symptoms of ALS and die. Like people with the disease, they gradually become paralyzed until they suffocate when breathing muscles stop working.

There is no cure for ALS and the causes are not clear. But the Johns Hopkins team wanted to see if grafting new cells into the body might help preserve some muscle function.

They used cells taken from an 8-week-old fetus, which had been donated by the mother after an abortion. Stem cells are partially developed but can give rise to a variety of different tissues if put into the right environment.

The cells from the aborted fetus are not the same as embryonic stem cells, currently at the center of a political debate in the United States. Fetal stem cells are intermediate between embryonic stem cells and so-called adult stem cells.

 
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They are somewhat more malleable than adult stem cells but not as plastic as embryonic stem cells.

In this case, the researchers took the cells from the developing spine. These cells are already destined to become nervous system tissue and do not elicit an immune rejection by the body, said Karl Johe, chairman and chief scientific officer of Neuralstem Inc. in Rockville, Maryland.

NO CURE

The researchers only transplanted cells into the lower spinal cords of the rats, in part because the animals are so tiny and the job is tricky, said Johe. Because the upper spinal cord controls the upper half of the body including breathing, there was no chance of curing the rats.

“They do develop symptoms and also they still die, but the onset is more slowly developing and the longevity is extended,” Johe said in a telephone interview.

They injected the human fetal stem cells into adult rats not yet showing symptoms and also killed some of the stem cells and injected them into other rats to act as a control.

On average, the rats treated with live stem cells started losing weight — one of the first symptoms of disease — after 59 days and they lived for 86 days. In contrast, the rats given the sham treatment started to lose weight at 52 days and only lived for 75 days.

While all the rats grew steadily weaker, the treated rats maintained their ability to crawl up a slope for much longer than untreated rats.

After the rats died the researchers examined their spines and saw that 70 percent of the transplanted cells had developed into nerve cells.

Johe said the company was growing and nurturing the cells and hoped to create many batches of purified cells that could be used for transplants for a range of patients with spinal cord diseases or injuries.

“If we see in a year … really significant effects (in rats) then I think we could be ready for a (human) clinical trial in another year after that,” Johe said

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Human Stem Cells Help Rats to Fend Off Lou Gehrig’s Disease

Human Stem Cells Help Rats to Fend Off Lou Gehrig’s Disease

By Rob Waters

Oct. 15 (Bloomberg) — Neural stem cells transplanted into the spinal cords of rats from a human fetus slowed onset of a form of Lou Gehrig’s disease, a condition that attacks the nerve circuits that control movement.

Researchers placed the cells in rats genetically engineered to develop a form of the disease, also know as amyotrophic lateral sclerosis or ALS. The rodents with the cells were slower to show symptoms such as weight loss and diminished strength, and lived about 11 days longer over a 30-month life span.

The finding suggests stem cells can be grafted into damaged nervous systems for a clinical benefit, contradicting the belief of many scientists. It may also eventually offer hope to about 5,600 people in the U.S. who are diagnosed yearly with ALS, which is almost always fatal.

“The dogma was that the spinal cord can not make neurons, or allow engrafted cells to become neurons,” said Vassilis Koliatsos, the Johns Hopkins School of Medicine neurologist who led the study, in an Oct. 12 telephone interview. “The assumption was also that because this is a toxic environment where motor neurons are dying, the cells would die.”

These assumptions “are increasingly proven wrong” by this research and other recent studies, he said. Koliatsos’s study was published today in the journal Transplantation.

The transplanted cells, which developed into neurons, or nerve cells, formed connections to existing neurons that had been damaged by the disease and were able to convey information through electrical signals and deliver proteins to help nourish the sick cells, Koliatsos said.

Neuralstem Inc.

The researchers used a line of neural stem cells developed by Neuralstem Inc., a closely held biotechnology company based in Rockville, Maryland. The company developed the line from fetal tissue donated by a woman who underwent an elective abortion at 8 weeks.

The stem cells, taken from an area near the developing spinal cord of the fetus, have the theoretical ability to develop or differentiate into any of three cell types found in the nervous system. The cells were kept alive in culture and chemically manipulated to keep them from differentiating.

The researchers exposed the spinal cords of the rats and used a tiny micropipette to inject cells. Rats in one group were given about 400,000 living neural stem cells; another control group was injected with dead cells.

The rats that got the live cells began losing weight at about 59 days on average, a week later than the rats in the control group. When made to walk an uphill plank as a strength test, the cell-treated rats performed better over a longer period of time. They also lived to about 86 days, 11 days longer than the control rats.

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When the rats were examined after their deaths, the researchers found that more than 70 percent of the transplanted stem cells had developed into nerve cells, and that many grew endings that connected to other cells, allowing them to transfer nerve impulses that direct muscular action and movement.

“These cells became neurons and they also made connections to sick neurons,” he said. “If you make connections to sick neurons, you close the circuit, you give them information.”

The connections allowed needed proteins and growth factors produced by the new neurons to pass to the damaged cells. This may help solve a problem that has vexed researchers. When scientists have delivered these proteins and growth factors, also known as trophic factors, using drugs, they reached unwanted targets and caused side effects, Koliatsos said.

`Delivers the Goods’

“You use the stem cell as a very complex biological structure or machine that manufactures and sends these trophic factors where they ought to be given,” he said. “It delivers the goods right on target.”

In this experiment, stem cells were injected in the portion of the spinal cord that controls the lower body. The next step, which Koliatsos has already begun working on, is to deliver the cells to the part of the spinal cord that controls upper body motion, including chest wall expansion and breathing.

“We need to do that, see if it’s well tolerated and see if we can extend their survival longer,” Koliatsos said. After that, he said, he’ll start thinking about how to study this type of treatment in people.

About 30,000 Americans have Lou Gehrig’s disease, according to the ALS Association. The disease begins with weakness in the arms and legs, and progresses to paralysis as motor neurons are damaged.

The study was funded by the National Institutes of Health, the Muscular Dystrophy Association and the university’s Robert Packard Center for ALS Research.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .

Last Updated: October 15, 2006 00:58 EDT

 

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