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Gene-Edited stem cells aim to tame HIV

NCT ID NCT02500849

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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