AIDS
Conditions
Brief summary
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.
Detailed description
Mesenchymal stem cells (MSCs) possess immunomodulatory, anti-inflammatory, and regenerative properties. The safety and effectiveness of MSCs have been investigated in various clinical trials for the treatment of several disorders, including graft-versushost disease, inflammatory bowel disease, and multiple sclerosis. It has been reported that MSC treatment in HIV-infected patients with immunological nonresponders resulted in a significant increase in circulating CD4+ T lymphocytes and a decrease of the activation of T lymphocytes and soluble inflammation mediator levels without significant adverse effects or loss of viremia control. However, the therapeutic efficacy of MSC treatment for AIDS patients at late stage is not well-understood. This study aims to investigate the safety and efficacy of MSC treatment for AIDS patients at late stage.
Interventions
DRUGmesenchymal stem cell
Mesenchymal stem cell dose is 0.75-1.0×10\*6/kg and is transplanted by intravenous infusion. For the mesenchymal stem cell standard treatment group, the cells are used for three times(at week 0, 2,4 after recruitment) and the mesenchymal stem cell enhanced treatment group, the cells are used for six times(at week 0, 2,4,24,26,28 after recruitment).
OTHERsaline
saline is used as placebo in the placebo comparator group
Sponsors
Beijing 302 Hospital
Shenzhen Third People's Hospital
Fifth Hospital of Shijiazhuang City
Beijing YouAn Hospital
Cell Energy Life Sciences Group Co. LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with side effects in MSCs treatment groups | 48 weeks | Investiagte the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after MSCs infusion. |
| CD4+ T cell counts after MSCs transfusion | 48 weeks | at week 12, 24 and 48, evaluate CD4+ T cell counts and compare with baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV RNA viral load | 48 weeks | At week 12, 24 and 48, test HIV RNA viral load in participants' blood using RT-PCR and compare with baseline. |
Countries
China
Contacts
Primary ContactFu-Sheng Wang, Doctor
Backup ContactRobert Chunhua Zhao, Doctor
Outcome results
None listed