Groundbreaking Gene Therapy Study Gets The Go-Ahead By The FDA

Calimmune, a small biotechnology company, is  giving people a low dose chemo agent (as conditioning) and then infusing them with stem cells  that have been modified to inhibit the CCR5 receptor and to contain their own built-in HIV fusion inhibitor peptide, thereby blocking two sites that are essential for HIV infection.  

The study is enrolling only for HIV+ people who have an R5 virus and who are not taking HIV medications due to their own choice (side effects, etc) for at least 6 weeks. Over 500 CD4 cells required.  Very promising approach  by Calimmune!

An Adaptive Phase I/II Study of the Safety of CD4+ T Lymphocytes and CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct, With and Without Conditioning With Busulfan in HIV-1 Infected Adults Previously Exposed to ART

This is the Los Angeles investigator. San Francisco also has a site but it has been fully enrolled

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