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Recruiting NCT05939167

Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

Phase I / Phase II Interventional AIDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mesenchymal stem cell, saline.
Who it may be relevant to
Registry conditions: AIDS. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

  • 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 saline
    saline is used as placebo in the placebo comparator group

Primary outcome measures

  • Number of participants with side effects in MSCs treatment groups [Time frame: 48 weeks]
  • CD4+ T cell counts after MSCs transfusion [Time frame: 48 weeks]
Secondary outcome measures (1)
  • HIV RNA viral load [Time frame: 48 weeks]

Eligibility criteria

Inclusion criteria

  • Confirmed HIV infection, aged 18-65, both genders
  • CD4+T count less than 500 cells/ul at baseline.
  • 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

  • have HBV/HCV/HDV/HEV infection, and the virological test is positive.
  • The viral load for CMV and EBV is more than 1000 copies/ML.
  • have HIV-2 infection.
  • have serious complications in organs including renal, circulatory, respiratory, digestive, endocrine, neural and immunological diseases and tumors.
  • received treatment of hormones or other immunosuppressive drugs for a long time.
  • with serious AIDS related or unrelated events.
  • received immunosuppressive drugs or systemic cytotoxic drugs for more than 3 months before recruiting
  • have poor compliance during treatment.
  • drug addiction within 6 months, or the urine drug test is positive
  • participate in other clinical trials currently
  • pregnant, breastfeeding, or have fertility requirements.
  • unable or unwilling to provide informed consents, or unable to comply with research requirements.
  • Other serious situations that may hinder clinical trials.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 4 centers
  • Beijing 302 Hospital — Beijing
  • Beijing YouAn Hospital — Beijing
  • Shenzhen Third People's Hospital — Shenzhen
  • The Fifth Hospital of Shijiazhuang — Shijiazhuang

Identifiers

NCT: NCT05939167 · 2022YFC2304403

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗