Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

January 10, 2024 updated by: Cell Energy Life Sciences Group Co. LTD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fu-Sheng Wang, Doctor
  • Phone Number: 8610-13671005510
  • Email: fswang302@163.com

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing YouAn Hospital
        • Contact:
          • Li-Jun Sun, Doctor
      • Beijing, China
        • Recruiting
        • Beijing 302 Hospital
        • Contact:
        • Principal Investigator:
          • Fu-Sheng Wang, Doctor
      • Shenzhen, China
        • Recruiting
        • Shenzhen Third People's Hospital
        • Contact:
          • Fu-Xiang Wang, Doctor
      • Shijiazhuang, China
        • Recruiting
        • The Fifth Hospital of Shijiazhuang
        • Contact:
          • Er-Hei Dai, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with side effects in MSCs treatment groups
Time Frame: 48 weeks
Investiagte the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after MSCs infusion.
48 weeks
CD4+ T cell counts after MSCs transfusion
Time Frame: 48 weeks
at week 12, 24 and 48, evaluate CD4+ T cell counts and compare with baseline
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV RNA viral load
Time Frame: 48 weeks
At week 12, 24 and 48, test HIV RNA viral load in participants' blood using RT-PCR and compare with baseline.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cell Energy Life Sciences Group Co. LTD

Collaborators

Beijing YouAn Hospital
Beijing 302 Hospital
Shenzhen Third People's Hospital
Fifth Hospital of Shijiazhuang City

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2023

Primary Completion (Estimated)

July 10, 2025

Study Completion (Estimated)

July 10, 2026

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

July 2, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2022YFC2304403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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