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The procedure was performed on patient Jeff Getty on Thursday, December 14 at 8:37 pm. Getty's condition following the infusion is good, and he is resting comfortably.
"Jeff tolerated the infusion very well, but the hard part is still ahead," said Steven Deeks, MD, one of the physician-researchers caring for Getty. "Jeff's own immune system will likely get weaker over the next few weeks before it gets stronger. The baboon's immune system, which is not going to replace Jeff's immune system, will probably not start helping for another three to six weeks."
The experimental procedure was attempted because baboons have been found to be resistant to HIV-1, the primary AIDS virus. If, as is hoped, the baboon cells join with the patient's bone marrow cells, the researchers believe that the patient's augmented bone marrow will then produce HIV-resistant CD4+ T cells. Theoretically, this would increase the patient's ability to ward off the opportunistic infections that can be fatal to AIDS patients.
The infusion took place at the UCSF-affiliated San Francisco General Hospital in the General Clinical Research Center (GCRC). Jeff Getty is an AIDS activist who has been the leading candidate for the trial since the Food and Drug Administration (FDA) approved the protocol in August 1995.
This is the first time a bone marrow cell infusion from one species to another--often called a xenotransplant--has been attempted using the specific scientific approach that has been approved for this study, the researchers said.
The physician-researchers who conducted the clinical study are Steven Deeks, MD, UCSF assistant professor of medicine in the UCSF AIDS Program at SFGH; Paul A. Volberding, MD, UCSF professor of medicine and director of the UCSF AIDS Program at SFGH; and Suzanne T. Ildstad, MD, professor of surgery, University of Pittsburgh.
The University of Pittsburgh team working with Ildstad are Marian Michaels, MD, MPH, assistant professor of pediatrics; Yolanda Colson, MD, PhD, assistant professor of surgery; and Christina Kaufman, PhD, assistant professor of surgery. Deeks is the primary physician providing clinical care for the patient. Ildstad processed the baboon bone marrow and prepared it for infusion. Morris Schambelan, MD, UCSF professor of medicine, has been involved in the study as chief of the GCRC.
It is Ildstad's work which makes this clinical trial a "first-of-its-kind." The xenotransplant was not an infusion of all the baboon bone marrow, rather it was a "cocktail" of only two types of cells, called stem cells and facilitating cells. It is hoped the baboon stem cells will improve the immune system and the facilitating cells will help the body accept the foreign tissue.
Ildstad and her Pittsburgh team were the first to identify the facilitating cell which, for a reason that is unclear to the researchers, allows stem cells to engraft in foreign environments, including other species, without the adverse reaction called graft-versus-host disease. "In the past when researchers tried to transplant stem cells into genetically different recipients they were universally rejected by the host," said Ildstad.
In her previous work, Ildstad was successful in transferring these cells from monkey to monkey, baboon to monkey and human to baboon, with the result that the stem cells engrafted.
"Even though there have been many exciting recent advances in HIV treatment, like new antiretrovirals, patients with advanced AIDS have few options and no options at all for restoring their immune function. We recognize that this clinical trial is highly experimental," said Deeks, "but we are hopeful that we have a chance to succeed and we should learn a great deal about HIV and the immune system."
Deeks and his colleagues emphasized that, even if the infusion is successful and the baboon cells "take," the patient will not be cured of HIV or AIDS. "The patient will remain HIV-infected for life," Deeks said.
The procedure did not require surgery, the researchers said, but rather was similar to a blood transfusion. The bone marrow cells from the baboon were processed by Ildstad and her Pittsburgh team in collaboration with colleagues at the UCSF Transplantation Research Laboratory which is directed by Nancy Ascher, MD, PhD, UCSF chief of transplant services. The cells were then infused into a vein in the patient's arm. The infusion procedure took approximately 30 minutes.
The infusion was not a classic bone marrow transplant, Deeks explained. In a classic transplant, the bone marrow of the recipient is destroyed in order to receive the donor marrow. In this clinical study, the object is to augment the patient's bone marrow, not replace it. The patient received low dose chemotherapy and radiation to make space in his bone marrow for the new cells.
"We did not have to destroy his immune system in order for the procedure to work. Therefore, he should not be profoundly at risk for infections," Deeks said. Getty is receiving aggressive antiretroviral treatments to help reduce the risks of the effects of the conditioning on his compromised immune system, Deeks said.
While it is difficult to predict whether the baboon cells will engraft in this trial and whether, if they do, the result will be an improved immune function, Deeks and his colleagues are confident that they can get stem cells and facilitator cells to engraft across species.
"We know we can do this because Dr. Ildstad has achieved it by taking human cells and infusing them into baboons. She has had these human cells engraft, in fact, in a dozen baboons. Now we are at the next obvious step--to go from the baboon to the human," Deeks said.
"The experiment is risky and may fail," said Volberding, whose leadership helped develop the protocol. "But, it has the potential to teach us much about the biology of HIV infection and its treatment."
"My doctors want to go forward with an experiment that may not save my life, but could well lead to a treatment that will save thousands of others," Getty said. "We can't let fears of theoretical risks stop research."
"Hopefully, this study will send the message that we, as clinicians and scientists, are frustrated by the slow progress being made in this disease," Deeks said. "It's time to start taking more risks."
NOTE TO EDITORS: Reporters who wish to receive condition reports on Jeff Getty should call a special information line which will have an updated message recorded twice daily. This line will not take messages. The number is 415/476-4082, extension 84123. The physicians will not be available for interviews over the weekend of December 16th and 17th.
CONTACT: UCSF Alice Trinkl, 415/476-3804
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