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Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

Sponsor
Cell Energy Life Sciences Group Co. LTD (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05939167
Collaborator
Beijing 302 Hospital (Other), Shenzhen Third People's Hospital (Other), Fifth Hospital of Shijiazhuang City (Other), Beijing YouAn Hospital (Other)
120
Enrollment
4
Locations
3
Arms
36
Anticipated Duration (Months)
30
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: mesenchymal stem cell
  • Other: saline
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jul 10, 2023
Anticipated Primary Completion Date :
Jul 10, 2025
Anticipated Study Completion Date :
Jul 10, 2026

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo control

use saline

Other: saline
saline is used as placebo in the placebo comparator group
Experimental: mesenchymal stem cells standard treatment

transplant mesenchymal stem cells for 3 times

Drug: 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).
Other Names:
  • umbilical cord derived MSCs

    		•
    Experimental: mesenchymal stem cells enhanced treatment

    transplant mesenchymal stem cells for 6 times

    Drug: 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).
    Other Names:
  • umbilical cord derived MSCs

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Confirmed HIV infection, aged 18-65, both genders

    2. CD4+T count less than 200 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing 302 Hospital Beijing China
    2 Beijing YouAn Hospital Beijing China
    3 Shenzhen Third People's Hospital Shenzhen China
    4 The Fifth Hospital of Shijiazhuang Shijiazhuang China

    Sponsors and Collaborators

    • Cell Energy Life Sciences Group Co. LTD
    • Beijing 302 Hospital
    • Shenzhen Third People's Hospital
    • Fifth Hospital of Shijiazhuang City
    • Beijing YouAn Hospital

    Investigators

    • Principal Investigator: Fu-Sheng Wang, Doctor, Beijing 302 Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cell Energy Life Sciences Group Co. LTD
    ClinicalTrials.gov Identifier:
    NCT05939167
    Other Study ID Numbers:
    • 2022YFC2304403
    First Posted:
    Jul 11, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 11, 2023