Gene-Edited stem cells aim to tame HIV
NCT ID NCT02500849
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving HIV patients their own genetically modified stem cells is safe and feasible. The cells are changed to resist HIV, and patients receive a mild chemotherapy drug before infusion. The goal is to see if the modified cells can help control the virus, but this is an early safety trial with only 12 participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2016
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Maximum age 75 years for cohort 1 and 65 years for cohort 2. * HIV-1 R5 seropositive with no evidence of CXCR4-tropic virus. * On cART with undetectable HIV-1 (\<20 gc/ml HIV-1 RNA) for at least 12 months prior to screening evaluations. * CD4+ T-cell counts ≥200 cells/µL and ≤750 cells/µL. * No psychosocial conditions that would hinder study compliance and follow-up. * Absence of clinically significant cardiomyopathy, congestive heart failure. Secondary Eligibility Criteria (for registration): * Complete G-CSF/Plerixafor mobilization of HSPC. * Collect ≥7.5 x 10\^6 CD34+ cells/kg in two aphereses. * The SB-728mR-HSPC product passed all release testing Exclusion Criteria: * Use of AZT or maraviroc in the cART regimen. * History of significant hematologic diseases such as leukemia, myelodysplasia, coagulopathy, and thromboembolism. * Any AIDS-related opportunistic infection occurring within the past year such as tuberculosis, cryptococcosis and for which treatment has been unsuccessful as determined by the Principal Investigator. * AIDS-related syndromes, infectious or otherwise, if perceived to cause excessive risk for morbidity post-HSPC infusion, as determined by the Principal Investigator. * Patients with active HBV or HCV infection, i.e., HBV DNA and HCV RNA in blood, are excluded. Those with inactive, but past infection with HBV (positive HBV surface antigen or HBV surface antibody) or inactive HCV (positive HCV antibody), must have no cirrhosis, as determined by abdominal ultrasound with elastography. * Active CMV retinitis or other active CMV-related organ dysfunction. * CXCR4-tropic virus. * Pregnant or nursing women. * Any history of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent. * Participants may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy. Participation in prior investigational drug or medical device study within the previous 45 days. * Current or history of immunomodulatory agent or steroid use. * Prior therapy with HIV vaccine or gene therapy product. * History of alcohol or substance abuse for the previous 12 months. * Participants with active malignancies. However, participants with skin cancers, namely basal cell or squamous cell carcinoma, and malignancies treated with curative intent having no known active disease present for ≥2 years, may be eligible.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HIV are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Circle CARE Center, LLC
Norwalk, Connecticut, 06850, United States
-
City of Hope Medical Center
Duarte, California, 91010, United States
-
Mills Clinical Research
Los Angeles, California, 90069, United States
-
Quest Clinical Research
San Francisco, California, 94115, United States
-
UCLA CARE Center
Los Angeles, California, 90035, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can 'Queen Mothers' bring HIV testing to the doorstep?
- Scientists map HIV's hiding spots in early infection
- Can local clinics keep more people with HIV in care?
- Can a phone call keep HIV-Positive mothers and babies on track?
- Can a phone app and a health worker ease depression in rural HIV care?
- Can a diabetes and Weight-Loss drug help break cocaine addiction?