Our Agency funds clinical trials testing promising stem cell or gene therapies for currently incurable diseases or disorders to help patients with unmet medical needs. For basic information about stem cell trials, visit our Clinical Trials 101 page. For a list of clinical trials related to HIV/AIDS click here.
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Current Clinical Trials
Anti-HIV duoCAR-T cell therapy for HIV infection
Anti-HIV duoCAR-T cell therapy for HIV infection
The University of California San Francisco (UCSF) is conducting a clinical trial that modifies a patient’s own immune cells in order to treat and potentially cure HIV.
Current treatment of HIV involves the use of long-term antiretroviral therapy (ART). However, many people are not able to access and adhere to long-term ART.
The team will take a patient’s blood and extract T cells, a type of immune cell. The T cells are then genetically modified to express two different chimeric antigen receptors (CAR), which enable the newly created duoCAR-T cells to recognize and destroy HIV infected cells. The modified T cells are then reintroduced back into the patient.
The goal of this one time therapy is to act as a long-term control of HIV with patients no longer needing to take ART, in effect a form of HIV cure. This approach would also address the needs of those who are not able to respond to current approaches, which is estimated to be 50% of those affected by HIV globally.
Sponsor:
University of California, San Francisco
Phase 1 Clinical research program for functional cure of HIV with EBT-101, in-vivo gene therapy
Phase 1 Clinical research program for functional cure of HIV with EBT-101, in-vivo gene therapy
Objective of the study is to conduct first-in-human (FIH) Phase 1/2a study. EBT-101 is a CRISPR-Cas9 endonuclease advanced therapeutic that selectively targets HIV-1 proviral DNA for its excision from integrated genome sites using two guide RNAs (dgRNA). Treatment is intended to enable sufficient reduction of the proviral population to achieve sustained HIV virologic suppression without the need for chronic antiretroviral therapy.
Sponsor:
Excision BioTherapeutics
HIV-related Lymphoma, HIV/AIDS
Stem Cell Gene Therapy for HIV Mediated by Lentivector Transduced, Pre-selected CD34+ Cells in AIDS lymphoma patients
A team at UC Davis is taking a patient’s blood forming stem cells and inserting three anti-HIV genes into them and then returning them to the individual to help rebuild their immune system. The anti-HIV genes are then passed on to all new immune system cells, which makes them resistant to HIV. Because AIDS-related lymphoma is linked to the constant immune cell stimulation caused by HIV infection, getting rid of the virus should prevent return of the cancer. More information
Sponsor:
AIDS Malignancy Consortium