Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage
NCT ID: NCT05939167
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2023-12-10
2028-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo control
use saline
saline
saline is used as placebo in the placebo comparator group
mesenchymal stem cells standard treatment
transplant mesenchymal stem cells for 3 times
mesenchymal 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).
mesenchymal stem cells enhanced treatment
transplant mesenchymal stem cells for 6 times
No interventions assigned to this group
Interventions
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mesenchymal 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).
saline
saline is used as placebo in the placebo comparator group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Beijing 302 Hospital
OTHER
Shenzhen Third People's Hospital
OTHER
Fifth Hospital of Shijiazhuang City
OTHER
Beijing YouAn Hospital
OTHER
Cell Energy Life Sciences Group Co. LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Fu-Sheng Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing 302 Hospital
Locations
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Beijing 302 Hospital
Beijing, , China
Beijing YouAn Hospital
Beijing, , China
Shenzhen Third People's Hospital
Shenzhen, , China
The Fifth Hospital of Shijiazhuang
Shijiazhuang, , China
Countries
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Central Contacts
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Facility Contacts
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Li-Jun Sun, Doctor
Role: primary
Fu-Xiang Wang, Doctor
Role: primary
Er-Hei Dai, Doctor
Role: primary
Other Identifiers
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2022YFC2304403
Identifier Type: -
Identifier Source: org_study_id
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