Tuesday, March 13, 2012

MS Drug the Next Treatment for Spinal Cord Injuries?

A drug found to slow some of the physical problems and reduce the number of flareups of multiple sclerosis (MS) could also show promise for treating spinal cord injuries, according to a new Japanese study.

Researchers from the Jichi Medical University School of Medicine and the Universisty of Tokyo's Graduate School of Medicine found that FTY720, also known as Gilenya, helped mice with spinal cord injuries (SCIs) recover some motor function when they were given the drug immediately after the injuries.

FTY720 acts in a number of ways, the study authors wrote. The drug, provided by its manufacturer, Novartis, for this study, suppresses the immune system, which reduces inflammation that occurs after injuries. Inflammatory effects, they explained, can worsen the damage done by SCIs. The drug also helped the mice's damaged tissue regenerate, among other effects.

"The main biological activity responsible for these actions is believed to be immunological, but our data suggest that nonimmunological role(s) of FTY720 are also important in the treatment of SCI," they wrote.

The drug still needs to be evaluated in larger animals before determining whether it is effective in treating SCIs, but still has promise, the authors added.

Experts not involved with the study, however, are a bit more skeptical. Many interventions work in mice, so determining the utility of Gilenya for SCIs in humans is a long way off, if it happens at all.

"Another issue is that in this study, the drug was given immediately after the SCI, and rarely do we have the opportunity to give a drug immediately after this type of injury in humans," said W. Dalton Dietrich, professor and scientific director of the Miami Project to Cure Paralysis at the University of Miami's Miller School of Medicine. "One big question is if the drug delivery is delayed, will it work?"

Few Early Treatment Options Available

Studies have found that in some people, the steroid drug methylprednisolone has been effective at restoring a little bit of function if given within eight hours of injury.

But other drugs -- mostly experimental -- that clinicians have tried with post-SCI patients have not been particularly effective.

"Acutely, we really don't have any drugs to try to protect the nervous system," said Dr. Bruce Dobkin, director of the Neurologic Rehabilitation and Research Program at UCLA's Geffen School of Medicine. "The most important thing is rehabilitation."

"Right now, during the time right after an injury, we focus on providing good stabilization of the spinal cord, physiological monitoring and early spinal decompression surgery if it's appropriate," Dietrich said.

Despite more and more research into possible treatments for spinal cord injuries over the past decade or so, Dobkin said formerly promising options have not lived up to their hype.

"All the things we've done to try and improve walking haven't turned out to be that great, like robotics, electrical stimulation and other interventions," he said.

Newer therapies include the use of stem cells to rebuild damaged nerve pathways and the use of cooling shortly after spinal cord injuries.

"In more than 30 patients, we tried mild cooling in the emergency room after patients came in with spinal cord injuries, and in those patients, the therapy seems to be safe and to provide some improvement in function," Dietrich said.

Although few effective therapies are out there right now, experts are optimistic.

"It's hopeful that within five or 10 years, we will have a couple of interventions we can use early that will give people more function," Dobkin said.

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Wednesday, March 07, 2012

Surgery less than 24 hours after traumatic cervical spinal cord injury leads to improved outcomes

Researchers at the Rothman Institute at Jefferson have shown that patients who receive surgery less than 24 hours after a traumatic cervical spine injury suffer less neural tissue destruction and improved clinical outcomes. The results of their study, the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS) are available in PLoS One.

"This practice-changing study is the first to show that the timing of surgery after traumatic spinal cord injury (SCI) matters," says Alexander Vaccaro, MD, PhD, professor of Orthopaedics and Neurosurgery at Jefferson Medical College of Thomas Jefferson University and attending surgeon at Thomas Jefferson University Hospital, the largest spinal cord injury center in the country.

The multicenter study recruited 313 patients; 182 of whom underwent surgery less than 24 hours after traumatic cervical SCI and 131 of whom underwent surgery at or after 24 hours post-SCI.

For both groups, the degree of neurologic improvement was measured by change in American Spinal Injury Association's (ASIA's) ASIA Impairment Scale (AIS). A two-grade improvement in AIS scores post-surgery was associated with improved neurologic outcomes. Baseline neurological assessments were performed within 24 hours of injury on all subjects.

A total of 222 patients were followed to six months post-surgery.

In the early surgery group (surgery performed less than 24 hours post-injury), 42.7 percent showed no improvement, 36.6 percent had a one grade improvement, 16.8 percent had a two-grade improvement and 3.1 percent had a three grade improvement. Comparatively, in the late surgery group (surgery performed at 24 hours or more post-injury), 50 percent showed no improvement, 40.7 percent had a one grade improvement and 8.8 percent had a two grade improvement.

"What this tells us is that the odds of a significant (at least two grade) improvement in neurologic status is 2.8 times higher when surgery is performed within 24 hours post-injury. This can be the difference between walking and not for the rest of one's life," says Vaccaro.

Complications occurred in 24.2 percent of early surgery patients versus 30.5 percent of late surgery patients.

"Previous research has been inconclusive on the issue, with the common thought among most surgeons that you can wait up to five days post-injury and have the same outcomes. We should not practice that way anymore armed with this new information," says Vaccaro.

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Young Aims for Spinal Injury 'Cure'

One of the world's leading researchers into spinal cord injuries says China could hold the key to a cure that he has been searching for since he met late actor Christopher Reeve in the 1990s.

US-based Doctor Wise Young first used the word "cure" in relation to his work after a conversation with Reeve, the Superman hero who became a quadriplegic in an equestrian accident in 1995.

Reeve contacted him looking for help and the two became close friends. The actor died of heart failure in 2004 at the age of 52, having devoted his life to raising awareness about spinal cord injuries and stem-cell research.

But it was a star of a different sort, Chinese gymnast Sang Lan, who set Young on the path he believes has brought a cure closer than ever, thanks to ground-breaking clinical trials of stem-cell therapy he is conducting in China.

"Everybody assumed that I'm doing this in China because I wanted to escape George W. Bush, but that's not the case at all," Young told AFP, recalling the former US president's 2001 decision to effectively stop federal funding of embryonic stem cell research.

"I started the clinical trials in 2005 here in Hong Kong . . . mainly because of a promise that I made to a young woman. Her name is Sang Lan."

Sang crushed her spine during a routine warm-up exercise at the Goodwill Games in New York in 1998. She met Young as she underwent treatment and rehabilitation in the US over the next 12 months.

"Her parents came to me and asked whether or not there would ever be a cure for her, and I said we're working very hard on it," said Young, who was by then one of the leading US experts on spinal cord injuries.

"When she went back to China after doing her rehabilitation in New York she cried and asked how would therapies go from the United States to China.

"In those days China was still relatively poor and backward so she didn't think that any therapy would be coming from China. So I started in 1999 to talk to all the spinal cord doctors in China."

He said the result was China Spinal Cord Injury Net, the world's biggest clinical trial network for spinal cord therapies. Established in Hong Kong in 2005, it is about to expand into Europe, India and the US.

"We're testing umbilical cord blood-cell transplants into the spinal cord combined with lithium treatments," said Young, professor in neuroscience at Rutgers University, New Jersey.

At about 20 centres in China, Hong Kong and Taiwan, stem cells are injected into patients' damaged spines to help regenerate nerves, while lithium is used to promote the growth of the nerve fibres.

Each component of the combination therapy needs to be tested separately before they are brought together in the third and final phase, due to take place in the coming years if all goes well.

The results so far have been promising, although it's "still too early" to draw conclusions about recovery of movement, Young said.

"What we can comfortably say right now is that the procedure seems to be quite safe. Nobody has lost any function," he said.

"We don't expect people to be jumping out of bed and running marathons after this. Regeneration is a slow process."

The trials also involve intensive walking exercises for some of the severely injured participants at the Army General Hospital in Kunming, south-western China.

In two sessions of three hours each, six days a week, the patients "sculpt" their nerve fibres into shape, Young said. He likened it to running a marathon every day. By comparison, Reeve did about two hours of exercise daily.

"The families are there cheering them on. There's a mass effect," said Young in his tiny office in central Hong Kong, where he was born into a business family in 1950.

"They are joshing with each other, saying, 'I'm going to beat you today'. There's that kind of atmosphere that allows you to do it six hours a day, and once it becomes a routine you keep going."

One of the tragic and little-known side effects of the country's booming economy is the rise in car crashes and construction site accidents, leading to soaring numbers of spinal injuries.

China's rate of chronic spinal cord injuries has increased more than 10-fold since 1995, and another 80,000 people are added to the list every year, according to Young.

Growing demand for therapies has led some unscrupulous Chinese researchers to offer stem-cell treatments at high prices, without any clinical proof that their methods are effective.

But Young said such problems existed everywhere. For him, the real story about China is how it has gone from the backwater of Sang Lan's day to a country at the cutting edge of spinal cord research.

Chinese Government spending on biomedical research is at least on a par with the US, and the legal framework governing its clinical standards is second to none, the doctor said.

"It's turned 180 degrees from the time Sang Lan was asking how will therapies get to China. Now Americans want to go to China," Young said.

"This is not what I would have said to Sang Lan back in 1998 but it is possible that the cure for spinal cord injury will actually come from China."

Young does not use the word "cure" lightly.

"Before I met (Reeve) I was very reluctant to use the word cure," he said.

"It's very scary to use because when you use the word cure you're committing yourself to a goal that most scientists feel uncomfortable with.

"We're not going to be able to make the body exactly the same as it was before the injury.

"What we should do is get (patients) to a point where you can't tell that they have been injured, and I think that is an achievable goal."

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