Clinical trial NCT05939167: Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: AIDS
Lead sponsor: Cell Energy Life Sciences Group Co. LTD
Sponsor class: INDUSTRY
Collaborators: name: Beijing 302 Hospital
name: Shenzhen Third People's Hospital
name: Fifth Hospital of Shijiazhuang City
name: Beijing YouAn Hospital
First posted: 2023-07-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Confirmed HIV infection, aged 18-65, both genders
2. CD4+T count less than 350 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.

Primary outcomes:
measure: Number of participants with side effects in MSCs treatment groups
timeFrame: 48 weeks
measure: CD4+ T cell counts after MSCs transfusion
timeFrame: 48 weeks
Secondary outcomes:
measure: HIV RNA viral load
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing 302 Hospital
city: Beijing
country: China
facility: Beijing YouAn Hospital
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
city: Shijiazhuang
country: China
facility: The Fifth Hospital of Shijiazhuang
Study officials:
affiliation: Beijing 302 Hospital
name: Fu-Sheng Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: