Friday, November 21, 2008

Nose Cells May Heal Spinal Cord Injuries

People paralysed by spinal cord injuries could soon be "repaired" using cells from their own noses, say Otago University researchers.


The Health Ministry's ethics committee has just approved an application by the Spinal Cord Society to open the way for a clinical trial involving 12 patients, which could start next year.

The society's president, Noela Vallis, said there was no shortage of volunteers ready to take part.

"Some have already gone overseas out of a sense of frustration that they can't access it [the experimental treatment] here," Mrs Vallis said.

About 5000 Kiwis are in wheelchairs as a result of accidents - the highest rate of any country in the developed world.

Research director Jim Faed, who heads the the Spinal Cord Society's lab at Otago University, has spent five years developing laboratory methods for growing cells potentially useful for spinal cord injury repair.

His team is focusing on two promising cell types: one is a kind of adult stem cell produced by a patient's own bone marrow.

However, researchers are likely to begin trials using olfactory (scent receptor) cells from the patient's nose, injecting them into damaged spinal cord.

"The olfactory tissue in the nose is unique because it is the only place in the body where there is constant replacement of nerve cells throughout life," Dr Faed said.

"There is growing medical opinion that these cells can help overcome the blocks that prevent nerve cells regenerating after damage to the spinal cord."

The nasal tissue acts like "nurse cells", providing growth factor hormone to nerve cells, enabling them to make "meaningful connections".

Internationally, several research groups have done animal trials using the cells, but there has been only one human trial - in Portugal in 2006. The Otago group is in contact with Portuguese neuropathologist Carlos Lima, who pioneered that trial.

Dr Faed said some participants experienced side-effects, but they were "few and manageable" and none had been fatal.

Positive benefits for patients included return of some muscle function and sensation in parts of the body which previously had no feeling.

Dr Faed said the Dunedin lab hoped to get full approval for the trial before Christmas, and would then begin recruiting patients. The first 12 could start treatment next year.

Mrs Vallis - who founded the society after her late husband was paralysed in an accident - said the group aimed to raise $1 million to fund the trial, in addition to the $300,000 it finds every year to run the lab. "We should be at the forefront of developing this medical treatment, given the number of our citizens in wheelchairs."

Feilding man Iain Scott, a quadriplegic since dislocating his neck while playing rugby 19 years ago, said the possibility of the treatment was "huge" and gave hope to people with spinal cord injuries. "If nothing happens, at least you had a go ... you don't want to die wondering."

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Promising Therapies for Spinal Cord Injuries

A quarter of a million Americans are currently living with spinal cord injuries, according to the National Institute of Neurological Disorders and Stroke.

Although most people know this type of injury can be a devastating diagnosis, not everyone knows there are many different types of spinal cord injuries. The location of the injury along the spinal cord determines what parts of the body are affected. Different types of spinal cord injuries include:
  • Cervical Spinal Cord Injury: Affects vertebrae C1-C8 and causes paralysis or weakness in both arms and legs. This is also known as quadriplegia or tetraplegia.
  • Thoracic Spinal Cord Injury: Affects vertebrae T1-T12. These injuries can cause paralysis or weakness of the legs along with loss of physical sensation, bowel, bladder and sexual function.
  • Lumbar Spinal Cord Injury: Affects vertebrae L1-L5 and result in weakness or paralysis of the legs. This is also known as paraplegia.
  • Sacral Spinal Cord Injury: Affects vertebrae S1-S5. Sacral level injuries mainly cause loss of bowel and bladder function as well as sexual dysfunction. They can also cause weakness of paralysis of the hips and legs.
Injuries can also be complete or incomplete. Complete injuries are indicated by a total lack of sensory and motor function below the level of injury, whereas incomplete injuries are marked by some remaining sensation and movement (Source: Paralysis Resource Center).

With spinal cord injuries, the speed and quality of medical attention can dictate how the patient will live the rest of his or her life. Immediate treatment can include medications, immobilization and surgery.

One of the most important drugs used to treat spinal cord injuries is methylprednisolone, an adrenal corticosteroid that protects against further damage if administered within eight hours of injury. However, this drug may pose a risk of harmful side effects.

Clinical trials of a compound called GM-1 ganglioside show it may be another drug that can protect against secondary damage in these types of injuries. The compound is also showing promise in improving recovery during rehabilitation, a process that all victims of spinal cord injury have to undergo -- sometimes for years.

Another promising therapy for spinal cord injury involves an electronic chip implanted in the brain. Studies in rats show the animals could move a prosthetic arm using only their thoughts.

Researchers from the University of Florida implanted an electronic chip into rats' brains. A computer decoded the chip, and over time, the computer learned to adapt to the rats' needs. When a rat thought about moving, the computer responded by moving a robotic arm.

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Monday, April 07, 2008

Experimental Russian Stem Cell Treatments Credited for Woman's Progress

Experimental Russian stem cell treatments for spinal injury credited for woman's progress


Notice: The following excerpts are taken from the Grand Rapids Press. A link the the entire article is listed below, and is well worth the time to read.
When Kadi DeHaan took her first steps in December, two years after a car accident forced her into a wheelchair, she did it in typical Kadi style: low-key, nonchalant and with a confident grin.


Apparently, she knew all along she would walk away from her pink and black wheelchair and her customized leg braces, despite a spinal cord injury at chest level and a grim prognosis that she would never walk again.

It happened after two years of intensive therapy and six trips to Russia, where her stem cells were harvested and then injected into her spinal cord to restore nerves.

Kadi's progress is "very much a unique and wonderful thing," said physical therapist Sandy Burns, director of the Center for Spinal Cord Injury Recovery in Rockford, a clinic affiliated with the Detroit Medical Center.

No one can say for sure if nearly two years of experimental treatments or hours upon hours of physical therapy -- a trio of three-hour sessions every week -- led Kadi to where she is today.

Probably both, said Burns, whose clients sometimes head to Russia or Portugal or China for treatments that aren't approved in the U.S. and generally aren't covered by insurance.

The physical therapy is a very important component, "but it's definitely Russia," that put Kadi back on her own two feet, Kadi's mom, Bonnie, insisted. "There are just too many coincidences. Kadi knows that what she's got she got from Russia."

After fundraising dollars ran out more than a year ago, Kadi's parents took out a loan to pay for the trips to Russia. The three-year protocol recommended by Moscow doctors will cost in excess of $150,000.

At the time, Kadi had just a bit of feeling in her feet and could walk only with lots of help from custom-built leg braces and a walker.

Since then, she's given up the braces and is "tons stronger" and "a lot more independent," she said. She's a full-time student at Davenport University who quaffs Mountain Dew and confesses to sending text messages during class.

"I've seen a lot of changes. I've seen motor return, sensory return, everything," Kadi said.

She's so convinced of the gains made at the NeuroVita Clinic that she's planning her seventh trip there in August. Quite a change of attitude after she declared the first trip "the worst three weeks of my life."

Burns, who is quick to say her clinic does not endorse any of the alternative treatments, acknowledged that the stem cell injections do seem to make a difference, at least for Kadi.

"Folks that have gone there have, I think, consistently reported that they are noticing changes. They are feeling more," Burns said.

She tempers her optimism with the reality of what she sees every day: some of her clients will never accomplish half as much as Kadi has. Progress often depends upon the severity of the spinal injury, not just the region of the spine that was damaged.

That's why Burns doesn't make predictions about what her clients will eventually accomplish. But of course, she hopes Kadi continues to make great strides.




The Neurovita Clinic


Where: Moscow, Russia
What: Treats spinal cord injuries, degenerative disorders and some cancers with patient's own stem cells, which are harvested, grown and re-injected. Clinic moved away from use of embryonic stem cells because of compatibility issues.
Insurance: Because treatment is experimental and not performed here, U.S. insurance policies don't cover it.
Website: neurovita.ru/eng_index.html

The NeuroVita clinic was founded by neurologist Andrey S. Bryukhovetskiy in 2002. It's located on the campus of the Russian State Medical University and can accommodate 35 patients.

The clinic dabbled in embryonic stem cell treatments but now uses only autologous material -- that which is obtained from the patient -- because there are no problems with compatibility, not to mention politics and religion, according to the Web site.

About 11 of every 100 patients with spinal cord injuries walk again after the stem cell treatments, Bryukhovetskiy told them.

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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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Wednesday, November 07, 2007

New Clinical Trials Could Open "Golden Era" In Spinal Cord Injury

New experimental therapies are being -- or soon may be -- tested in clinical trials that could open the doors to a "golden era" for research to improve the treatments of people with spinal cord injuries, brain injuries, stroke, and other severe movement disorders, scientists say.

"The studies highlighted here reflect decades of basic science research that have led to some measure of understanding the events taking place in traumatic neural injury and disease, and how these events can be modulated to improve function," says Aileen Anderson, PhD, of the University of California, Irvine.

"As a result of this work, we have the exciting opportunity to begin testing these pathways in the clinical setting in an attempt to minimize the progression of damage and, in some cases, perhaps repair it," says Anderson.

The new therapies include an experimental, custom-made antibody to NOGO-A, one of several inhibitory proteins for nerve fiber growth that are produced naturally in the human spinal cord and brain. It soon will be evaluated as a therapy for patients who are newly paralyzed from spinal cord injury.

This Phase I clinical trial, conducted by the European Network of Spinal Cord Injury Centers, follows extensive laboratory research on NOGO-A, as well as animal tests of the experimental monoclonal antibody's effectiveness in neutralizing the inhibitory protein.

NOGO-A is one of several proteins whose existence in the adult body helps to explain our limited ability to grow new brain and spinal cord tissue in response to injury or disease, says Martin Schwab, PhD, of the Brain Research Institute at the University of Zurich in Switzerland. These inhibitory proteins, which are silent during embryonic and fetal development and even during the first few months of an infant's life, vigorously limit the inherent ability of adult brain and spinal cord neurons to regrow fibers that have been cut by injury.

"As a result, neurons as well as their axons retain a low growth potential following brain trauma or spinal cord injury," Schwab says. Axons transmit from neurons the electrical impulses that underlie our ability to move our arms and legs.

To restore fiber-growing ability to the brain and spinal cord, Schwab first prevented NOGO-A from fulfilling its function as an inhibitor of fiber growth and regeneration in laboratory animals. He showed that the anti-NOGO-A antibody allowed fiber tracts of the rats' damaged spinal cords to regenerate partially, thereby restoring some motor function.

"Animals treated with such reagents showed molecular changes which strongly suggest that the growth machinery of the nerve cells is turned on, similar to the situation during development," Schwab says. Anatomical studies showed that the antibody treatment induced long-distance regeneration and the formation of new circuits.

"Nerve fiber tracts that were not directly affected by the injury also sprouted after treatment," Schwab says. These physical changes restored some of the animals' leg movement, a "remarkable behavioral recovery," he adds. "Many animals showed almost full recovery in sensory as well as motor tests." The untreated, or control, animals in the study remained severely impaired.

"The coming few years will show whether the step from bench to bedside can be successfully achieved in spinal cord injury and central nervous system trauma without the danger of serious side effects or complications," Schwab says.

In another presentation, Michael Fehlings, MD, PhD, of the Toronto Western Hospital and University of Toronto described several current or planned clinical trials for treating spinal cord injury. Immediate treatment may not only reverse the initial damage to the spinal cord but also may minimize secondary injury, potentially sparing the patient additional neurological problems, Fehlings says.

The prospective clinical study, titled STASCIS, which is evaluating the role and timing of early decompressive surgery in patients with cervical spinal cord injury, has to date enrolled more than 240 patients. The study, he says, is based on the premise that within hours of a spinal cord injury, a patient should be undergoing surgery that will reduce pressure on the cord in order to limit damage to it and surrounding tissues. Initial evaluations of the clinical trial data have indicated that immediate surgery is safe and feasible and, by reducing the pressure on a compressed spinal cord, may encourage the recovery of function.

In another clinical trial, scientists soon will determine whether the Food and Drug Administration-approved medication riluzole protects nerve cells and promotes functional recovery when it is administered after spinal cord injury. Riluzole, now used to treat people with amyotrophic lateral sclerosis (ALS), prevents neurons from releasing too much sodium. In lab animal studies, the drug was neuroprotective.

In other animal model studies, the drug CethrinŽ has been found to lessen post-traumatic neural cell death. To evaluate the safety of this recombinant protein drug and obtain preliminary efficacy data in human patients, Fehlings and colleagues at nine centers in the United States and Canada administered the agent topically to 37 patients with complete cervical and thoracic spinal cord injury. "The drug shows a high degree of safety and promising clinical neurological improvements after one year of follow-up," he says.

"While the results of a single arm, uncontrolled study need to be interpreted cautiously, this level of improvement exceeds rates of spontaneous neurological recovery," Fehlings says. A prospective, randomized placebo-controlled efficacy trial is planned for early 2008.

The Fehlings team has completed studies in lab rodents in which neural stem cells were transplanted following spinal cord injury. The stem cells, programmed to restore the myelin layer around spinal cord nerve fibers, promoted significant neurological recovery. This strategy shows considerable promise for translation into the clinic, Fehlings says.

If it continues beyond a critical time point, the medical practice of treating spinal cord-injured patients with immune suppressive drugs as soon after the injury as possible may hinder rather than promote recovery, according to studies by Michal Schwartz, PhD, of the Weizmann Institute of Science in Rehovot, Israel.

"For many decades, the detection of immune cells in the injured brain or spinal cord was interpreted to represent part of the pathological process that occurs following injury and prevents healing," Schwartz says. "This dogma was so well ingrained that the common practice in Western countries has been to treat patients who experienced spinal cord injury with immune suppressive drugs as early as possible following the injury."

However, Schwartz's laboratory showed that the immune system is required for protection, repair, and renewal of the brain and spinal cord following acute or chronic damage. But, she says, "to achieve beneficial results, immune-cell involvement in repair must be critically controlled in terms of the timing, nature, intensity, and duration of activation."

A beneficial immune response involves not only the activity of immune cells residing in the damaged tissue, but also the timely recruitment of immune cells from the blood. These blood-borne immune cells home to a precise location around the injured site, where they sense the tissue damage and secrete factors needed to induce repair.

"This timely recruitment of immune cells to the site of injury, and their well-controlled activation, is an essential stage in the multistep process of brain and spinal cord repair," Schwartz says. "Curtailing this process by suppressing, rather than modulating, the immune response deprives the tissue of its most powerful physiological repair mechanism."

Schwartz designed and tested several immune-based therapeutic approaches for promoting spinal cord repair. One was a vaccine containing a peptide derived from a protein that resides in the injured tissue and that can boost immune response by activating a particular population of immune cells, the T lymphocytes. T lymphocytes specifically recognize proteins that are associated with the injury.

Pairing the vaccine with an injection of neural stem cells resulted in a synergistic effect on recovery. "Surprisingly, however, the injected stem cells did not themselves give rise to new neurons but rather promoted the formation of new neurons from the tissue's resident stem cells," Schwartz says.

Scientists also have found in work with laboratory animals that when human stem cells are transplanted into the body, they form active synapses with the animal's own neurons for limb movement. After they were implanted, the human stem cells developed into neurons and made local connections with spinal cord motor neurons but they did not project to the animals' peripheral nerve and hind limb muscles, says Vassilis Koliatsos, MD, of Johns Hopkins University.

Koliatsos conducted this study with rodents affected by a genetic form of ALS, which is characterized by the progressive degeneration and death of motor neurons. "These findings demonstrate that grafted human neural stem cells become synaptically incorporated into the motor circuitry of ALS rats," Koliatsos says.

The exact role of these new synapses, which are specialized junctions through which neurons signal each other, is not yet defined. Koliatsos says that they may serve to communicate physiological signals pertaining to limb movement or, more likely, to transfer nourishing chemicals from neural stem cells to the degenerating or vulnerable motor neurons of the host ALS animal.

The transplanted human stem cells produced an abundance of two key nourishing chemicals for motor neurons: glial cell-derived neurotrophic factor and brain-derived neurotrophic factor (BDNF), which, Koliatsos says, "may be the main factor behind the therapeutic effect of neural stem cell grafts."

In the latest study, the implanted human neural stem cells, obtained from a 2-month-old human fetal spinal cord, were transplanted into the spinal cord of ALS rats when they were 9 weeks old.

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Friday, September 21, 2007

Drug Can Help Patients Heal From Spinal Cord Injuries

According to the Spinal Cord Injury Information Network, there are about 11,000 new spinal cord injuries each year. Car accidents have been responsible for nearly 50 percent of spinal cord injuries since 2000, and falls have been the second most common cause of spinal cord injuries. Currently, about 253,000 Americans are living with a spinal cord injury.

Dr. Michael Fehlings from Toronto Western Hospital is studying a new drug to treat spinal cord injuries soon after they happen. The drug, called Cethrin, is applied during surgery to the injury site in a fibrin glue type of material. Cethrin is a recombinant protein that is made through artificial DNA technology. The protein inhibits Rho, a key pathway that triggers cell death and increases damage after a spinal cord injury.

"You apply [Cethrin] directly to the damaged spinal cord and then the medication penetrates the damaged spinal cord," Fehlings said.

Cethrin is still under study, but early results look promising. Results from a one-year study of the drug in 37 patients were presented in April, 2007 at the annual meeting of the American Association of Neurological Surgeons in Washington, D.C. All patients in the study had "A" grade injuries, which are the most serious. Injuries are graded from A to E, with A being the most serious and E being the least serious.

Patients received Cethrin an average of 53 hours after their injury occurred. After six months, 28 percent of patients improved by one or more grades. Five patients improved to a "C" grade, and two improved to a "D" grade.Typically, there is some recovery that occurs after an injury, but the rates of recovery are quite low, in the range of 5 percent to 10 percent.

"In this trial, fully a third of patients showed significant recovery, and almost 20 percent of the patients showed a major degree of recovery. In my own clinical experience, this type of recovery is very unusual," Fehlings said.

Fehlings says the drug is not a cure for spinal cord injuries, but it could have a major impact on patients' lives.

"They might be able to now grip a jar or to drink, or they might be able to transfer themselves, whereas before they might not have had trunk control. In some patients, it might even mean that they could recover the ability to walk," he said.

At least five institutions in the United States and three in Canada are studying Cethrin's role in spinal cord injuries.

By: Ivanhoe Broadcast News

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Thursday, June 28, 2007

Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury

Patients Experienced Increased Mobility After Treatment; Preliminary Results Involving 25 Patients Presented at International Society for Cellular Therapy?s Annual Meeting in Sydney

PrimeCell? Therapeutics LLC announced that it provided research support and pre-clinical studies for a clinical trial to assess the safety, feasibility and efficacy of implanting autologous bone marrow stem cells into spinal cord injury (SCI) patients.

Dr. Luis Geffner presented a preliminary report at the 13th Annual Meeting of the International Society for Cellular Therapy, held here June 24-27. From May 2006 to January 2007, 25 patients with SCI were treated at Luis Vernaza Hospital in Guayaquil, Ecuador. They were treated with autologous bone marrow stem cells ? meaning the cells were extracted from the patients' own bone marrow.

Fifteen patients (60 percent) could stand up, ten patients (40 percent) could walk on the parallels with braces, seven (28 percent) could walk without braces, and four (16 percent) could walk with crutches. Patients demonstrated improvements in sensitivity, motility, bladder sensation, even controlling sphincters, erection and ejaculation. No adverse event was observed.

"These preliminary results, while encouraging, must be interpreted cautiously and prudently, and we must continue work examining the benefits of surgically implanted autologous bone marrow stem cells to patients with spinal cord injuries," said Geffner, director of the stem cell program at the Junta de Beneficencia de Guayaquil. He emphasized that this work was done with the help and support of the Junta de Beneficencia, Benemerita Sociedad de Lucha Contra el Cancer (SOLCA), and with the research support and pre-clinical studies performed by stem cell biologist and senior author Francisco Silva and his team at PrimeCell Therapeutics, based in Irvine, Calif.

The study included in vitro (laboratory tests), pre-clinical (animal) and clinical (human) data.

"There is evidence demonstrating significant improvement in the quality of life of patients receiving the treatment, including spinal cord regeneration and additional clinical improvements following these stem cell transplants,? said Silva, vice president of research and development for PrimeCell Therapeutics. ?More research is needed, of course, but this is very encouraging. Our ultimate goal, as always, is not just research ? but research that will lead to timely viable therapies."

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Saturday, March 10, 2007

Scientists plan China, HK, Taiwan Stem Cell Trial

Scientists are preparing for a large clinical trial in 2008 which aims to use stem cells to help 400 patients with spinal cord injuries in Hong Kong, mainland China and Taiwan grow new cells and nerve fibers.

Stem cells from umbilical cord blood will be injected into the spinal cords of the participants, who will also be given lithium to help stimulate cell regeneration, said Wise Young, a leading neuroscientist and spinal cord injury researcher.

"What we'd like to do is study a broad range of patients, not just (those with) complete (spinal cord injuries)," said Young, professor at Rutgers' department of cellbiology and neuroscience. Rutgers is the state university in New Jersey in the U.S.

Researchers are now giving lithium to 20 patients in Hong Kong in the phase 1 safety and feasibility trial. Lithium is a chemical element that is believed to boost cell regeneration.
In preparation for the large 2008 trial, which will involve 400 patients in 14 mainland Chinese cities, Hong Kong and Taipei, doctors in all three places recently agreed on the method to deliver stem cells into spinal cords, said Young, who is also a visiting professor at the University of Hong Kong.

Stem cells extracted from matching umbilical cord blood taken from public blood banks will be injected into the spinal cords of the subjects, who will also be given lithium.

The procedure should hopefully help subjects grow new nerve fibers and "bridges" -- structures that allow the new fibers to reconnect with other parts of the spinal cord.

"Our main outcome measure will be neurological motor and sensory scores," Young said in an interview with selected media. "We want to see whether the patients recover sensation. It has three measures: touch, pain which is assessed by pin-prick, and the third is strength of 10 standardized muscles."

The trial, the biggest in the field in Asia, comes as China is devoting significant resources into stem cell research.

Its attitude and achievements have drawn U.S.-based scientists like Young to conduct research there due to opposition to embryonic stem cell research in the United States.

Opponents of embryonic stem cell research, including President George W. Bush, say it is unethical to experiment on human embryos, even those never destined to become a baby.
Stem cells are the body's master cells, found throughout the tissue and blood. Whether from the adult or from embryos, they may be used to find treatments and cures for serious diseases such as cancer and diabetes.

Embryonic stem cells are considered potentially the most powerful but are also the most controversial, and federal law greatly restricts the use of taxpayer money to pay for experiments using them.

"Scientists in the U.S. are so upset at the stopping of (embryonic) stem cell research, but this would be a great opportunity for Asia, great opportunity for China ... because there are so many researchers working in this field," Young said, adding that Hong Kong had a special position in all of this.

"Hong Kong is in a special position for science because it has credibility. Many people don't trust what is going on inside China," he said, noting also that Hong Kong badly needed government support and funding.

Private donors are funding the US$26 million spinal cord clinical trial.

By Tan Ee Lyn HONG KONG, Reuters

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