Treatment of late-stage AIDS patients using mesenchymal stem cells
Official title: A Double-blind, Randomized Placebo-controlled Clinical Trial to Investigate the Safety and Efficacy of Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage
Run by Cell Energy Life Sciences Group Co. LTD · NCT05939167 · Data updated 2026-11-12
This study is testing if mesenchymal stem cells can help improve the health of people with late-stage AIDS compared to those receiving a placebo.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Cell Energy Life Sciences Group Co. LTD Industry-sponsored |
| Locations | 4 sites (Beijing and 3 other locations) |
| Status | Recruiting |
| Started | December 10, 2023 |
| Main results expected | July 10, 2027 |
| Study ends | July 10, 2028 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT05939167 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are HIV-infected individuals aged 18-65 with a CD4+ T count less than 350 cells/µL and no serious AIDS-related events.
✕Probably not a fit
Patients with active infections such as HBV, HCV, or serious organ complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of mesenchymal stem cell (MSC) treatment in patients with late-stage AIDS. It is a prospective, double-blind, randomized placebo-controlled trial that will involve administering MSCs to participants and comparing the outcomes with those receiving a saline placebo. The study will focus on measuring changes in CD4+ T lymphocyte counts and other immunological markers, as well as monitoring for any adverse effects. The goal is to better understand the therapeutic potential of MSCs in this patient population.
Why it matters
Potential benefit: If successful, this treatment could improve immune function and overall health outcomes for late-stage AIDS patients.
How similar studies have gone: Previous studies have shown promising results with MSC treatment in HIV-infected patients, but this specific application for late-stage AIDS is less understood.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Confirmed HIV infection, aged 18-65, both genders 2. CD4+T count less than 500 cells/ul at baseline. 3. No serious AIDS related events. 3. could understand and sign the informed consent form and comply with the requirements of this study. 4\. agree not to participate in other studies and not to receive other immunotherapies during the period of participation in this study Exclusion Criteria: 1. have HBV/HCV/HDV/HEV infection, and the virological test is positive. 2. The viral load for CMV and EBV is more than 1000 copies/ML. 3. have HIV-2 infection. 4. have serious complications in organs including renal, circulatory, respiratory, digestive, endocrine, neural and immunological diseases and tumors. 5. received treatment of hormones or other immunosuppressive drugs for a long time. 6. with serious AIDS related or unrelated events. 7. received immunosuppressive drugs or systemic cytotoxic drugs for more than 3 months before recruiting 8. have poor compliance during treatment. 9. drug addiction within 6 months, or the urine drug test is positive 10. participate in other clinical trials currently 11. pregnant, breastfeeding, or have fertility requirements. 12. unable or unwilling to provide informed consents, or unable to comply with research requirements. 13. Other serious situations that may hinder clinical trials.
Where it's running
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Beijing 302 Hospital
Beijing, China Recruiting -
Beijing YouAn Hospital
Beijing, China Recruiting -
Shenzhen Third People's Hospital
Shenzhen, China Recruiting -
The Fifth Hospital of Shijiazhuang
Shijiazhuang, China Recruiting
Study contacts
- Principal investigator: Fu-Sheng Wang, Doctor — Beijing 302 Hospital
- Study coordinator: Fu-Sheng Wang, Doctor
- Email: fswang302@163.com
- Phone: 8610-13671005510
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.