пятница, 2 марта 2012 г.

First patient to have experimental stem cell therapy comes forward

In the six months since scientists announced they had infused adrug made from human embryonic stem cells into a partially paralyzedpatient's spine, the identity of the recipient has been shrouded insecrecy.

Recently, rumors began circulating in Internet chat rooms thatdetails about the closely guarded experiment were finally about tobe revealed.

Now, a 21-year-old Alabama nursing student who was paralyzed fromthe chest down in a car crash in September has come forward toidentify himself as the volunteer.

"I was the first patient," Timothy J. Atchison of Chatom, Ala.,said in a telephone interview with The Washington Post on Wednesdayevening. "I'm doing well."

Atchison, known as T.J. to his family and friends, was a studentat the University of South Alabama College of Nursing when his carcrashed on Sept. 25, which, Atchison noted, was the birthday ofChristopher Reeve, the actor who suffered a devastating spinal cordinjury.

After undergoing emergency treatment at a regional medicalcenter, Atchison was transferred to the Shepherd Center in Atlanta,which specializes in spinal cord injuries, for rehabilitation. Itwas there that he agreed to let doctors inject him with the drug -more than 2 million cells made from stem cells into his spine, hesaid.

"I feel really good about everything," Atchison said. "I've got apositive attitude. I'm trying to live life to the fullest rightnow."

The experiment is the first carefully designed attempt to studyan embryonic stem cell therapy. It is seen by supporters andopponents of embryonic stem cell research as potentially pivotal tothe future of the research, which proponents say could revolutionizemedicine and critics denounce as immoral.

The trial is primarily assessing safety, but doctors are alsotesting whether the cells restore sensation and movement.

Atchison said he has returned to the Shepherd Center three timesfor follow-up testing and was scheduled for at least two more visitsthis year, but he would not discuss whether there was any evidencethe therapy was helping.

"It's too early to talk about that. We're just in the earlystages right now. It's not at the stage to really know what's goingon," he said.

Atchison, who has learned to drive a specially equipped car thatdoes not require the use of his legs, said he was planning to returnto his studies in August.

"I plan on getting back to school," he said.

Atchison's father said that his son has maintained a positiveattitude, beginning when he was in the emergency room after theaccident, and that he understood how seriously he was injured.

"He said, whatever the Lord leaves him with, he'll do the best hecan with it," Atchison's father, Timothy Atchison of Millry, Ala.,said in a telephone interview Monday.

The Shepherd Center and the Geron Corp. of Menlo Park, Calif.,which is sponsoring the study, declined to comment.

After many delays, Geron finally persuaded the Food and DrugAdministration last July to allow the company to study 10 patients.Geron spent months training special teams of doctors at seven secretsites around the country so that they could be ready to act quickly.The teams then had to wait for a patient who met the study's strictcriteria - someone who had been paralyzed from the chest down withinthe previous two weeks.

Surgeons planned to use specially designed equipment to infuseinto the first patient's spine about 2 million "oligodendrocyteprogenitor" cells, which Geron scientists had created in thelaboratory from embryonic stem cells obtained from days-old embryosleft over from fertility treatments. The hope is that the cells willform a restorative sheath around the damaged spinal cord. In testsin hundreds of rats, partially paralyzed animals regained theability to move, according to Geron.

The study is being closely monitored by scientists eager toadvance the research from the laboratory to the clinic, as well asby patients and patient advocates hoping for cures. Although thecells have been tested in animals, and some clinics around the worldclaim to offer therapies using human embryonic stem cells, the trialis the first vetted by the FDA to evaluate the strategy in people.

But in addition to being criticized by those citing moralobjections to research using the cells because human embryos aredestroyed to obtain them, the study has also raised alarm among someproponents of the research. Some argue that the experiment ispremature. Others question whether it is ethical. Many fear that thetrial risks becoming a major step backward if anything goes wrong,such as the cells causing tumors, or if there is no sign that thecells help.

Spinal cord injuries are also highly unpredictable. Patientsoften improve on their own, which makes gauging whether the cellshad any effect dicey. Some also wonder whether trauma victims whohave so recently suffered a life-altering injury might agree to theexperiments out of desperation without fully understanding therisks.

Supporters say they are confident that the study had beenadequately vetted. The FDA demanded extensive experiments in thelaboratory and on animals to provide evidence that the cells holdpromise and are safe to test in people. Even if problems occur,research shows that the cells do not leave the site of the injury,indicating patients would not experience negative effects, Geronsaid. Each subject is assigned an independent advocate to ensurethat volunteers fully understand their decision.

Neither Timothy Atchison nor any of his family members woulddiscuss his decision-making process, saying he was working with afamily friend to tell his story in a book.

"I just met with my literary agent. We're trying to figure outwhat's in my best interest to talk about right now," he said.

On her blog, the family friend, Tory Minus of Millry, recountedAtchison's experience.

"Almost six months ago, my mom called shortly before 8 o'clock ona Saturday morning to tell me that a close family friend namedTimothy (or T.J., as most refer to him) was involved in a terribleautomobile accident," Minus wrote. "Mom could barely get the wordsout. T.J. had suffered a severe injury to his spinal cord and wasbeing air-ambulanced to a regional medical center some 60 milesaway."

Research director Madonna Lebling contributed to this report.

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