Treatment of late-stage AIDS patients using mesenchymal stem cells

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

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
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Cell Energy Life Sciences Group Co. LTD (Industry-sponsored)
• Locations: 4 sites (Beijing and 3 other locations)
• Trial ID: NCT05939167 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with active infections such as HBV, HCV, or serious organ complications may not benefit from this study.

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 performed: Previous studies have shown promising results with MSC treatment in HIV-infected patients, but this specific application for late-stage AIDS is less understood.

Eligibility 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 this trial is running

Beijing and 3 other locations

• 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

Conditions AIDS