Tuesday, September 01, 2009

New data on Paralysis Could Impact Future Treatment Strategies

Sufficient information on the prevalence of Americans living with paralysis and spinal cord injuries (SCI) has always been hard to come by. Most information cited in educational literature and on many Web sites regarding paralysis and SCI is extremely outdated. This presents numerous hurdles in devising new or evaluating existing policies, programs, and services for people living with these types of disabilities.

In 2004, The Christopher & Dana Reeve Foundation brought together a task force of more than 60 scientists, scholars, health advocates, and experts from the U.S. Centers for Disease Control and Prevention (CDC) and numerous universities, policy centers, and nonprofit health care organizations to identify what was needed to improve the quality of life for people living with paralysis. In order to complete this complex initiative, the Paralysis Task Force first needed to obtain more recent data on the individuals they were trying to assist.

With support from the University of New Mexico?s Center for Development and Disability (CDD) in partnership with the Christopher & Dana Reeve Foundation?s Paralysis Resource Center (PRC), researchers designed and conducted a survey of more than 33,000 households across the country??one of the largest population-based samples of any disability ever conducted. The new data demonstrates that paralysis may be dramatically more widespread than previously thought.

Below are some of the report?s major findings:
  • Approximately 1.9 percent of the U.S. population, or 5,596,000 people reported they were living with some form of paralysis, defined by the study as a central nervous system disorder resulting in difficulty or inability to move the upper or lower extremities. This is about one-third more Americans living with paralysis than previously estimated (4 million).
  • The leading cause of paralysis was stroke (29 percent), followed by spinal cord injury (23 percent) and multiple sclerosis (17 percent).
  • Data indicate that 1,275,000 people in the United States are living with spinal cord injury?more than five times the number of Americans previously estimated in 2007 (255,702).


These findings have major implications for the treatment of spinal cord and paralysis-related diseases?not only for those living with these conditions, but also for their families, caregivers, health care providers, and employers. As the number of people living with paralysis and spinal cord injuries increases, for example, so do the costs associated with treating them. Each year, paralysis and spinal cord injuries cost the health care system billions of dollars. Spinal cord injuries alone cost roughly $40.5 billion annually?a 317 percent increase from costs estimated in 1998 ($9.7 billion),? the report states.

If you have yet to read this important report conducted by the Christopher and Dana Reeve Foundation, you can access the 28-page PDF here.

By NY Disability Examiner Tom Scott

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Tuesday, July 28, 2009

Stem-Cell Breakthrough

It's a chilling thought. In the coming year, 130,000 people worldwide will suffer spinal-cord injuries?in a car crash, perhaps, or a fall. More than 90 percent of them will endure at least partial paralysis. There is no cure. But after a decade of hype and controversy over research on embryonic stem cells?cells that could, among other things, potentially repair injured spinal cords?the world's first clinical trial is about to begin. As early as this month, the first of 10 newly injured Americans, paralyzed from the waist down, will become participants in a study to assess the safety of a conservative, low-dose treatment. If all goes well, researchers will have taken a promising step toward a goal that once would have been considered a miracle?to help the lame walk.

The trial signals a new energy permeating the field of stem-cell research. More than 3,000 scientists recently met in Barcelona for the annual conference of the International Society for Stem Cell Research, compared with just 600 researchers five years ago. Money from major pharmaceutical companies is following the advances. Former U.S. vice president Al Gore, now a partner in the venture-capital firm Kleiner Perkins Caufield & Byers, has thrown his weight behind the research. In April, the firm joined with Highland Capital Partners to invest $20 million in iZumi Bio (now iPierian), a startup firm working on stem-cell therapies.
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Despite the considerable hype surrounding stem cells in recent years, the possibilities now appear to be broader than most people realize. In addition to helping replace damaged cells in patients with diseases like diabetes or Parkinson's, stem cells have the potential to change how we develop drugs and unravel the biology of disease. They may even be used one day to create replacement organs. "There's been a massive injection of optimism into the field," says stem-cell biologist Alan Trounson, president of the California Institute for Regenerative Medicine. "It's remarkable how fast it's progressing."

Much of the excitement comes from the development of a new type of stem cells, called "induced pluripotent" stem cells, or iPS. Shinya Yamanaka first concocted the cells in his Kyoto University lab by inserting four genes into fully formed adult skin cells. They began to behave like embryonic stem cells, capable of forming unlimited copies of any of the body's 220 cell types. Because iPS cells can be derived from a patient's own adult cells, they do not carry the risk of rejection by the immune system. Equally important, because iPS cells are not derived from embryos, they skirt a major ethical and religious problem.

The first iPS cells, however, will not be used as replacement tissue for spinal cords and other organs. Because iPS cells have subtle (and potentially dangerous) differences from true embryonic stem cells, many doctors are leery of putting them directly into patients until more research is done. But the cells could be immensely important in helping scientists understand and treat genetically based diseases.

By the time a full-blown disease has emerged, says Harvard stem-cell biologist Konrad Hochedlinger, it's like an airplane that has crashed. You can examine the wreckage for clues, but what you really want is the plane's black boxes?the flight-data and cockpit voice recorders that tell you exactly how electrical systems failed, hardware malfunctioned, and pilots made crucial errors. That's what doctors think iPS cells could provide. By coaxing some iPS cells into becoming the cell types affected in Huntington's disease, type 1 diabetes, or ALS (Lou Gehrig's disease), scientists will be able to watch in the lab as the disease unfolds. They'll be able to understand how the disease starts, which could lead to new ways of blocking it.

Embryonic stem cells are still regarded as the gold standard. That's why there is intense interest in the U.S. spinal-cord-injury trial. Sponsored by Geron Corp. in California, the trial will recruit patients within one to two weeks of their injuries, before scar tissue has formed. Doctors will inject a derivative of stem cells, called progenitor cells, that manufacture myelin, the substance that coats the long, spindly projections on nerve cells, much the same way that insulation coats electrical wires. Damage to cells that make and maintain the myelin sheath, as happens in spinal-cord injuries, prevents nerves from conveying messages from the brain. Although it's not clear yet whether the treatment is effective or safe, the restoration of even partial function would be a huge advance.

Geron's CEO, Dr. Thomas Okarma, thinks that spinal injury is a logical place to begin. Because patients will be completely paralyzed from the waist down, any improvement will be the result of the therapy, not chance. And the spinal cord is an "immune-privileged site," meaning that the attack cells of the immune system cannot get in and destroy the embryo-derived cells. "If the therapy is safe and effective, the potential impact will extend way beyond spinal-cord injury," says Okarma. "It will mark the start of a new era in medical therapeutics."

Other companies aren't waiting for the results. The U.S. pharmaceutical giant Pfizer is pursuing two other embryonic-stem-cell-based therapies, which it hopes to have in clinical trials by 2011. In April the company partnered with University College London to pursue a therapy for macular degeneration, the principal cause of blindness in the elderly. The disease leads to the gradual destruction of the macula, the sensitive central portion of the retina. But Peter Coffey, professor of cellular therapy and visual sciences at UCL, is using embryonic cells to make the same type of support cells that lie just behind the retina, providing it with nutrients. The goal is to implant a disc-shaped layer of the cells behind the retina. Immune rejection should not be a problem, since the eye is also immune-privileged.

Pfizer's other collaboration, with Novocell in California, aims to devise a treatment for some of the 100 million patients worldwide with insulin-dependent diabetes. Novocell is using embryonic stem cells to help regenerate all five of the pancreas's cell types. But there's a hitch. Unlike the eye or the spinal cord, the pancreas has no immune protection. For this, Novocell has devised a clever solution. It encases the stem-cell-derived progenitor cells in a capsule that can be implanted in the body. The pore size of the fabric is large enough to allow oxygen, glucose, and insulin to pass through but small enough to keep out big immune cells. "If problems should develop, the surgeon can easily remove the capsule," says Liz Bui, director of intellectual property for Novocell.

Some researchers aren't interested in just replacing impaired cells. They're using adult stem cells?which exist within organs to help with minor repairs?to grow entire replacement organs and tissues. Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest University in North Carolina, has made human bladders in this way. He starts by taking a small bladder biopsy from the patient and extracting his or her stem cells. After allowing the cells to multiply in the lab for about a month, he spreads them onto a collagen scaffold fashioned in the shape of a bladder. He then incubates the would-be organ in a bioreactor that provides the same temperature, oxygen level, growth factors, and nutrients that would be found in the body. In two weeks, he has a small but functional organ, ready for a patient.

In the early 2000s, Atala completed the procedure on seven children with spina bifida, who never developed fully functional bladders. He has now followed these patients for eight years to make sure there are no drastic failures or side effects. And he has moved on to other possible replacement parts. "We're working on 22 tissues and organs, including kidneys, heart valves, and cartilage," he says.

Because any new therapy is inherently risky, researchers are careful about creating false hopes that cures are just around the corner. Therapies that succeed in the idealized world of the lab can fail in real life or take decades to put into practice. As doctors and regulators begin to consider treating patients, they still have basic questions. Will the cells survive for long in the body? Will they integrate to form functioning tissue? Will the benefits outweigh risks that may become apparent only decades from now? Scientists are daring to hope, though, that after a decade of hype, real progress is imminent. Millions of patients worldwide could one day be the beneficiaries.

By Anne Underwood | NEWSWEEK

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Friday, November 21, 2008

Nanotechnology for Spinal Cord Injury

A cure for spinal injuries that leave people paralyzed, currently incurable, is being developed by Researchers at Northwestern University in Chicago. They are looking into using new nanotechnology that could enable them to completely heal cut and severed spinal cords allowing the previously paralyzed to walk again.

Spinal cord injury often leads to permanent paralysis and loss of sensation below the site of the injury due to damaged nerve fibers which can?t regenerate. These nerve fibers (axons) have the capacity to grow but don?t because they are blocked by scar tissue that have developed around the injury. Northwestern University researchers have shown that a new nano-engineered gel inhibits the formation of scar tissue at the injury site and enables the severed spinal cord fibers to regenerate and grow.

The gel is injected as a liquid into the spinal cord and self -assembles into a scaffold that supports the new nerve fibers as they grow up and down the spinal cord, penetrating the site of the injury. When the gel was injected into mice with a spinal cord injury, after six weeks the animals had a greatly enhanced ability to use their hind legs and walk.

However it was stressed that the results were preliminary and there is no magic bullet and it may not necessarily work on humans, but it helps a new technology to develop treatments for spinal injuries.

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Monday, October 27, 2008

Researchers Developing Therapy to Treat Paralysis

A team of researchers at Case Western Reserve University in Cleveland, Ohio are developing a new therapy that will help paralysis victims regain control of their muscles.

Functional Electrical Stimulation uses electric currents to stimulate muscles that no longer receive messages from the brain.

"When someone has a spinal cord injury, it's like they cut an electrical wire," Brian Heidenreich, associate professor of psychology, said. "The neurons that control muscles in the spinal cord are still there, but they don't get any messages from the brain."

Strokes may also damage or limit interaction between the brain and the muscles.

"Strokes wipe out the motor cortex, which controls motor movement in the body," Heidenreich said.

Organizations like the Food and Drug Administration, the State of Ohio and the National Institute of Health provide funding for FES research.

"The majority of the research programs at the Cleveland FES Center focus on spinal cord injury (SCI) and stroke," Mary Buckett, Cleveland FES researcher, said. "SCI programs at the FES Center vary and range from high level tetraplegia to incomplete paraplegia."

The actual treatment is an implanted prosthesis that restores communication between the brain and the muscles.

Researchers can also make the frontal lobe - the part of the brain that controls learning and thought - perform the tasks of the motor cortex with an FES device.

"It is possible to get brain regions to take over functions that weren't theirs originally," Heidenreich said.

Other FES programs focus on illnesses like Multiple Sclerosis and Osteoporosis. The programs are located in countries like Argentina, Canada, Australia, Poland, Japan and Italy.

A majority of the volunteers at the Cleveland center, Buckett said, have already sought traditional therapies. For them, FES treatment is seen as an additional opportunity to regain the ability to stand, apply make-up or write. In MS patients, FES therapy can reduce hand tremors by 50 percent.

The therapy may also restore basic bladder, breathing and hearing functions and eliminate the occurrence of urinary tract infections, loss of bone density and muscular atrophy.

Buckett, a former architect, explained in an FES Center document that her implant allows her to live as she did before she became paralyzed.

"I am less dependent on ? people to take notes in class for me or manipulate books and papers on my shelves and desk," she said.

"It has been amazing to witness individuals regaining function and independence," Buckett said. "To see someone stand from their wheelchair with pride and confidence and shake hands whilebeing introduced is a wonderful thing."

FES therapy still needs to go through additional testing, research, technological advances and FDA approval before researchers submit it for widespread use.

"This study is clearly a step toward making a device _that allows movement by people with paralysis, but it's one in a series that may achieve that goal," Heidenreich said.

By: Joanna Pelletier

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Thursday, February 07, 2008

Could a Spinal "Bypass" Reverse Paralysis?

A breakthrough in spinal surgery yesterday offered hope to victims of paralysis.

The technique, which has been tested on rats, involves bypassing damaged tissue in the spine.

This allows signals to travel across injured areas, New Scientist reports.

Dr John Martin and his colleagues at Columbia University in New York have so far tested the procedure only on rodents. They selected a motor nerve branching from the healthy cord above the injury and cut it away from the abdominal muscle to which it is normally attached.

They then stretched the free end across the injured section of spinal cord and used a protein "glue" to fix it.

Two weeks later the team found that the graft had sprouted new extensions which had begun to form connections - or synapses - with the motor nerves in the isolated lower spine.

Zapping the spinal cord above the injury made the lower limbs of the rats twitch - showing motor signals had started once again to pass along the entire length of the spine.

The researchers say removing the nerve from the abdominal muscle did not appear to cause any major side effects and suggest this is because nearby nerves pick up the slack.

Fellow neuroscientist Dr Reggie Edgerton, of California University, said the approach had considerable clinical potential but added that it was too early to tell whether it would work in humans.

Dr Marie Filbin of the City University of New York cautioned that it may not be possible to "reprogramme" a nerve that normally connects to an abdominal muscle to transmit the sophisticated signals needed to produce fine, controlled movements.

But Dr Martin, who presented his study at the New York State Spinal Cord Injury Research Program Symposium, said: "What we want to do is plug in new connections to bypass the damaged region."

He believes that - with a little surgical assistance - spinal cord nerves above an injury could be capable of making such connections with nerves lower down the spine.

He said: "We know the nerves can make new connections to muscle so we asked whether it's possible for them to also connect with spinal cord neurons isolated through injury."

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Tuesday, May 01, 2007

Doctors Try New Injection To Fight Paralysis

There are currently no effective therapies for spinal cord injuries. But a protein injection may help some patients walk again.

Two years ago, Michelle Robinson was on her way home from work when she was hit by a car.

"All I remember is hearing a loud screeching noise and I remember going, flying up in the air," Michelle said.

The accident left the 42-year-old mother paralyzed. Now she hopes an experimental drug will put her back on her feet.

"It appears that this actually does improve their prognosis," said James Harrop, a neurosurgeon.

Harrop is testing the novel drug called Cethrin to treat spinal cord injuries.

"It's a paste or a jelly that you sort of just spread onto the spinal cord with a little applicator, like a syringe," he said.

Doctors apply the protein during standard decompression surgery to stabilize the spine. The idea is to stop nerve cell death that includes days to weeks after the injury occurs.

"Inside the cell, there?s a nucleus which is controlling sort of this, the auto-regulator of the cell and what it?s doing is it?s telling the cell we don?t want you to function anymore," Harrop said.
Cethrin is designed to interfere with that message by seeping through the spinal cord membrane to cells at the injury site.

"It goes into the cell and it says 'wait a minute'. I don't want you guys going down that path anyways, I want you to stop and I want you to start repairing the cell," Harrop said.

Early trials show the protein therapy is safe. And the results are promising. Michelle says she is both excited and hopeful the new therapy will work for her.

"I say those words because Dr. Harrop told me that he was very hopeful that, you know, maybe one day I would be able to walk again, so I'm very hopeful also."

Doctors caution that Cethrin, also called BA210, is not a magic bullet. But in the study, 31 percent of patients regained some function after being injected with the drug. The study is still enrolling patients. About 253,000 Americans are living with a spinal cord injury. Roughly 11,000 new cases occur every year.

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