Groundbreaking Gene Therapy Study Gets The Go-Ahead By The FDA
Posted Dec 22 2012 12:00am
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 http://www.clinicaltrials.gov/ct2
This is the Los Angeles investigator. San Francisco also has a site but it has been fully enrolled