(BETA) News Briefs: FDA Approves Baboon Bone Marrow Transplant for AIDS Patient

(BETA) News Briefs: FDA Approves Baboon Bone Marrow Transplant for AIDS Patient

Bulletin of Experimental Treatments for AIDS, No. 26 September 1995
Ronald Baker, PhD

After 2 days of public testimony from scientists and AIDS activists, FDA's Biological Response Modifiers Advisory Committee recommended on July 14 to allow AIDS patient and ACT UP/Golden Gate activist Jeff Getty to receive a bone marrow transplant from a baboon. The panel voted unanimously (with one abstention) that Getty and his physicians should decide whether or not to proceed with the ground-breaking transplant, as long as Getty is well-informed about the risks. FDA has accepted the recommendation, and in late July gave researchers at the University of California in San Francisco (UCSF) permission to proceed with the highly experimental procedure.

HIV-1 cannot infect baboon immune cells, and the hope is that the bone marrow transplant will restore Getty's severely-damaged immune system. Although many transplant experts believe that the chances for success of the cross-species transplant are small, others see the experiment as an opportunity for progress that could eventually prolong the lives of people with a variety of human diseases. Some scientists testified that non-human viruses or other pathogens that actively or latently infect the baboon might infect Getty and those with whom he later comes in sexual contact. "If you don't want to risk the public health, then don't do it," said virologist Jonathan Allan of the Southwest Foundation for Biological Research in San Antonio, TX.

Suzanne Ildstad, MD, of the University of Pittsburgh said her research team has screened dozens of baboons at a cost of over $100,000 to locate disease-free baboons, but none are completely virus-free. Ildstad said she doesn't think they can find better animal candidates. Steven Deeks, MD, of UCSF, who will perform the operation, told reporters the transplant could take place in October 1995.

FDA says it will continue to evaluate cross-species cellular transplant proposals, but will allow local Institutional Review Boards (IRB) to decide on the merits of proposals for organ xenotransplants, using guidelines the agency is currently developing. These new guidelines should be published before the end of 1995.

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