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Researchers at the School of Medicine have partnered with Adaptimmune, Ltd. for the first-ever study to use HIV-positive patients’ own modified immune cells to specifically target and attack infected cells.

Adaptimmune, an offshoot of Oxford University, developed the altered immune cells by modifying t-cells, which seek out and destroy infected cells, so that they bind more effectively to the molecular fingerprint of cells infected by HIV.

Pathology and Laboratory Medicine Professor Carl June and Pablo Tebas, director of Penn Med’s Adult AIDS Clinical Trials Unit, will run the study, a phase I clinical trial.

Researchers will take five to 10 billion immune cells from patients in a process similar to platelet donation, grow them in culture until they have close to one quintillion cells, modify them and re-introduce them into the patients’ bodies, according to Bruce Levine, associate professor of Pathology and Laboratory Medicine.

According to Levine, the Med School is uniquely qualified to conduct trials of this sort because of its access to patients through the Hospital of the University of Pennsylvania and its experience in scaling up production as a treatment moves through the clinical trial process.

Phase I trials typically recruit five to 20 patients to examine the safety and feasibility of the treatment. If the genetically engineered t-cells prove safe, the researchers will use a phase II trial to refine the design of the treatment, and a phase III trial with several thousand patients to check the effectiveness of the t-cells against the best HIV/AIDS treatments currently available.

A drug or procedure in Phase I Clinical trials is far from being ready for market. Most treatments take 15 to 20 years to reach widespread release. As a post-baccalaureate at Penn Med in 1985, Levine worked on a chickenpox vaccine in Phase I trials. Merck released the vaccine in 1995.

“It takes a long attention span because these clinical trials take years to develop, years to conduct and then years to analyze,” Levine said. “What is continually gratifying and exciting is to be here and conduct these kinds of trials.”

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