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Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage
Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

NCT05939167

RecruitingPhase 1, Phase 2

Sponsor: Cell Energy Life Sciences Group Co. LTD

Conditions: AIDS

Interventions: mesenchymal stem cell, saline

Countries: China

The goal of this study is to conduct a prospective, double-blind, randomized placebo-controlled clinical trial to investigate the safety and efficacy of mesenchymal stem cells treatment for AIDS patients at late stage.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (4)
  • Beijing, China
  • Beijing, China
  • Shenzhen, China
  • Shijiazhuang, China