Panel OKs Baboon Marrow Transplant for AIDS Patient

A Food and Drug Administration advisory panel Friday gave permission for a controversial experiment to infuse a San Francisco AIDS activist with bone marrow obtained from a baboon in a last-gasp effort to save his life.

Some experts warned the panel that the experiment--the first animal-to-human bone marrow transplant--was more likely to hasten activist Jeff Getty’s death than to prevent it. But researchers from UC San Francisco and the University of Pittsburgh argued that the HIV-resistant baboon blood would attack the virus in Getty’s blood and prolong his life.

Getty has been infected with HIV for 14 years; his condition has been deteriorating and physicians predict he has less than a year to live. His tearful mother and sister pleaded with the panel in Bethesda, Md., on Friday to allow the experiment.

“Don’t take this hope away from him,” pleaded his mother, Susan Getty. “Unless you do something now, he will be dead.”

Although the panel approved the experiment, the FDA itself must give its consent, a process that could take another two weeks. Dr. Steven Deeks of UC San Francisco said he must also take a revised protocol back to the university’s Institutional Review Board for approval, and that could take four to six weeks. The earliest the therapy could occur would be late September, he said.

Nonetheless, he said he was “relieved and a bit surprised” that the panel had given its approval. “We’ve been through a two-year process and taken this through half a dozen regulatory boards. I was becoming more and more pessimistic.”

The transplant had originally been scheduled for April, but the FDA intervened to order two days of hearings that were held this week before the panel issued its approval.

“This is wonderful,” Getty’s sister Kim said as she raced to phone the news to her brother in San Francisco.

The technique to be used on Getty was developed by Dr. Suzanne Ildstad of the University of Pittsburgh, who recognized that HIV does not infect the cells of baboons, which are closely related to humans.

But the key to her approach is the discovery of a blood cell, which she calls a facilitator cell, that makes a cross-species bone marrow transplant possible.

For reasons that scientists do not yet understand, infusing a mixture of baboon facilitator cells and stem cells--the primitive blood cells manufactured in bone marrow that are the progenitors of all other blood cells--into a recipient prevents graft-versus-host disease, the normally fatal reaction in which the transplanted immune cells attack the recipient.

Ildstad conceded to the panel that the approach had been tested only in mice to date, and argued that a human test is necessary to validate it.

Critics, however, fear that graft-versus-host disease will appear in humans receiving the treatment. “This will probably hasten [Getty’s] death, not prevent it,” Dr. Hugh Auchincloss Jr. of Massachusetts General Hospital told the panel.

Critics also worry that any viruses in the baboon blood may either infect humans directly or combine with a human virus to produce a new and potentially deadly infectious agent. They note, for example, that the influenza virus is most likely transferred to humans from pigs and that HIV itself is probably a monkey virus that was somehow transferred to humans.

The two baboons scheduled to be donors for Getty’s therapy are known to be infected with five viruses, and the panel recommended that the team search for uninfected animals. Getty, 38, and his doctors will be tested regularly for disease.

Nonetheless, Getty is eager to proceed. “I am going to die anyway,” he said. “Let’s get on with finding some answers about this disease. If this saves me, then I got lucky.”

Said his sister Jennifer: “This is what he really wants to do--to push the science forward for this disease.”

Times wire services contributed to this story.