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Gene Therapy Against HIV Not a Proven Cure, Experts Say
Date:3/1/2011

natural immunity to HIV.

"Most of us consider [the Berlin patient] functionally cured, after three-and-a-half years. They can't find any virus," Kolber said.

To determine whether this feat could be safely replicated in other patients, a group of researchers at California-based biotech company Sangamo BioSciences used genetic engineering to create HIV-resistant versions of CD4+ T-cells, the immune system cells that are the prime target of HIV. They did so by first removing some of these cells from six HIV-infected male patients.

The T-cells were then modified using a special gene-editing technique, and billions of the newly tweaked genes were then infused back into the HIV-positive men.

The modified cells lack a key protein receptor -- also known as a "docking station" -- called CCR5, through which HIV invades the T-cells that are major players in the human immune system. A very rare handful of people are naturally missing both copies of the CCR5 gene and have appeared to be completely resistant to HIV.

On Monday, the team announced that, three months later, the new HIV-resistant cells were flourishing within the patients -- meaning that the men's bodies were now making some of their own HIV-resistant cells.

"The procedure is safe (so far) and feasible, in that all patients can be treated (i.e. no manufacturing failures), and thus the phase I protocol has met its objectives and can be deemed 'successful,'" said lead researcher Dr. Carl June, director of translational research at the Abramson Family Cancer Research Institute at the University of Pennsylvania School of Medicine.

"This is the first example of genetic editing to introduce a disease-resistance gene in patients: thus we have a new tool that will permit us to ask if we can eventually replicate the 'Berlin' patient with the patient's own cells, and not require bone marrow transplant from an unrelated donor," June explained. "A series of clinical trials can
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