The Bay Area Reporter - July 25, 1995
John Kimball ACT UP/Golden Gate Writer's Pool

Say you have AIDS and fewer than 50 CD4 cells. You discover that someone who has been repeatedly exposed to HIV has never become infected. You think that if you could get some of their immune system stem cells you could gain this resistance. There's just one catch - the "someone" with these resistant cells is not a person, but a baboon. What do you do?

If you are Jeff Getty, AIDS activist and member of ACT UP/Golden Gate, you do everything in your power to become "Baboon Man."

Getty is no stranger to new medicine. In 1994 he took part in a study of allogeneic lymphocyte transfer (ALT) that involved receiving transfusions of white blood cells from his sister, in an effort to stimulate his immune system. Aside from encouraging rises in his own CD8 levels, Getty's body also cleared any trace of cryptococchus, an unexpected benefit of the procedure.

Xenogeneic transfer is not a new concept. Human to other species (including baboons) transfers and transplants have been going on for years, as have a limited number of non-human to human transplants. But what is different is the type of material being transferred.

This is not a heart or a liver that can be removed if the host has a complete graft rejection: these are stem cells that live and work in the bone marrow producing the immune cells to identify and remove harmful foreign antigens that get into the body.

If the procedure works the baboon stem cells may produce HIV-resistant CD4 cells that will work to clear Getty's system of HIV and HIV-infected cells. A long shot? Absolutely. But it makes sense. Science knows baboon CD4 cells are resistant to HIV in the test tube, and also knows that baboons themselves are resistant to infection by HIV. The next logical step is exactly what Getty, Dr. Suzanne Ilstad of the University of Pittsburgh, and Drs. Michael Deeks and Paul Volberding of SFGH are proposing: the introduction of baboon stem cells into the body of a person infected with HIV.

The proposed treatment regimen is relatively simple. First Getty will undergo two bone marrow biopsies. He then will be subjected to sub-lethal doses of radiation to suppress his own embattled immune function and the ablation of his remaining CD4 and CD8 cells. At that point baboon stem cells will be injected into Getty. If all goes as planned, within two to three weeks Getty will start to see some bone marrow function, and at four to six weeks baboon progeny cells - CD4 and CD8 cells naturally resistant to HIV being produced by Getty's body. Getty himself sees the procedure as "all natural gene therapy." If the study produces the desired results, a small pilot study involving four people may be undertaken.

Getty realizes there are major risks involved. After irradiating his immune system he could be subject to rampant opportunistic infections. There could be severe Graft (baboon) to Host (Getty) disease, whereby the graft would kill the host. Or Getty could experience an explosion of HIV production that could overwhelm his system and cause death. Getty also knows that even if the transfer works, there is a definite window of time before his system will reject the graft. At last year's Immune Restoration Think Tank, sponsored by Project Inform, Getty talked to researchers about xenogeneic transfers. Their major concern was the chances for a lasting dual immune system. The question is how long will the window be - two days? Two months? Two years? At this point in his life, Getty is willing to accept most anything that can offer him time.

An 18-month-long road

Getty started looking at the protocol 18 months ago. He watched as the proposal was cleared by the Biosafety Committee at UCSF and various other Institutional Review Boards charged with reviewing new medical science. Everything was going as planned with hopes that Getty would get his first injection in June, until the FDA stepped in on April 27 of this year. The government labeled this as an experimental procedure under their jurisdiction, and decreed that an Investigational New Drug (or IND) application be filed. This meant an immediate delay of three to four months just to get a hearing.

The FDA scheduled a hearing before their Biologic Modifier Response Advisory Committee on July 14 in Washington, DC. Because of his inability to travel, Getty could not attend the meeting that would determine his fate, but family members and other AIDS activists attended on his behalf. Matthew Sharp of ACT UP/Golden Gate was one of those in attendance. He commented on the charged atmosphere of the hearing, noting that everyone in the room knew that they were on the cutting edge of something very important. Even with their own reservations, committee members were aware of the tremendous implications of this research. This promising procedure could be used not just for AIDS, but also for diabetes, leukemia, even cancer. The potential is enormous.

However, even with a unanimous recommendation from the Advisory Committee to go forward, the FDA could still reject the proposed study. Getty feels that the FDA will give its approval: the question is when. If it does not come in a month's time, Getty says that will be the time to take further action. As he said, "Several individuals have volunteered for gene therapy and other novel, dangerous research. This is no different, but its been sensationalized because of the baboons."

Jeff Getty celebrated his 38th birthday on the day of the advisory committee's hearing. He plans on being here to celebrate his 39th birthday. When asked why he is risking his life to try this unique therapy, Getty said there are two reasons, "First, I want to see science pushed forward. And second, I'm rolling the dice for that small chance that this might help me."

At this stage of the game called AIDS, that chance is xenogeneic transfer.
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