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First patient to get stem cell therapy comes forward

| Source: washingtonpost.com

In the six months since scientists announced they had infused a drug made from human embryonic stem cells into a partially paralyzed patient’s spine, the identity of the recipient has been shrouded in secrecy.

Recently, rumors began circulating in Internet chat rooms that details about the closely guarded experiment were finally about to be revealed.

Now, a 21-year-old Alabama nursing student who was paralyzed from the chest down in a car crash in September has come forward to identify 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 Wednesday evening. “I’m doing well.”

Atchison, known as T.J. to his family and friends, was a student at the University of South Alabama College of Nursing when his car crashed on Sept. 25, which, Atchison noted, was the birthday of Christopher Reeve, the actor who suffered a devastating spinal cord injury.

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

“I feel really good about everything,” Atchison said. “I’ve got a positive attitude. I’m trying to live life to the fullest right now.”

The experiment is the first carefully designed attempt to study an embryonic stem cell therapy. It is seen by supporters and opponents of embryonic stem cell research as potentially pivotal to the future of the research, which proponents say could revolutionize medicine and critics denounce as immoral.

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

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

“It’s too early to talk about that. We’re just in the early stages right now. It’s not at the stage to really know what’s going on,” he said.

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

“I plan on getting back to school,” he said.

Atchison’s father said that his son has maintained a positive attitude, beginning when he was in the emergency room after the accident, and that he understood how seriously he was injured.

“He said, whatever the Lord leaves him with, he’ll do the best he can 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.

Special teams trained

After many delays, Geron finally persuaded the Food and Drug Administration last July to allow the company to study 10 patients. Geron spent months training special teams of doctors at seven secret sites 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 strict criteria — someone who had been paralyzed from the chest down within the previous two weeks.

Surgeons planned to use specially designed equipment to infuse into the first patient’s spine about 2 million “oligodendrocyte progenitor” cells, which Geron scientists had created in the laboratory from embryonic stem cells obtained from days-old embryos left over from fertility treatments. The hope is that the cells will form a restorative sheath around the damaged spinal cord. In tests in hundreds of rats, partially paralyzed animals regained the ability to move, according to Geron.

Supporters, critics watch

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

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

Spinal cord injuries are also highly unpredictable. Patients often improve on their own, which makes gauging whether the cells had any effect dicey. Some also wonder whether trauma victims who have so recently suffered a life-altering injury might agree to the experiments out of desperation without fully understanding the risks.

Supporters say they are confident that the study had been adequately vetted. The FDA demanded extensive experiments in the laboratory and on animals to provide evidence that the cells hold promise 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, Geron said. Each subject is assigned an independent advocate to ensure that volunteers fully understand their decision.

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

“I just met with my literary agent. We’re trying to figure out what’s in my best interest to talk about right now,” he said.

On her blog, the family friend, Tory Minus of Millry, recounted Atchison’s experience.

“Almost six months ago, my mom called shortly before 8 o’clock on a Saturday morning to tell me that a close family friend named Timothy (or T.J., as most refer to him) was involved in a terrible automobile accident,” Minus wrote. “Mom could barely get the words out. T.J. had suffered a severe injury to his spinal cord and was being air-ambulanced to a regional medical center some 60 miles away.”

By Rob Stein
Research director Madonna Lebling contributed to this report.

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