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NCT Number: NCT05939167

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.

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Key information

Conditions

AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing 302 Hospital, Beijing, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

Mesenchymal stem cell

Drug

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

Saline

Other

saline is used as placebo in the placebo comparator group

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fu-Sheng Wang, Doctor

CONTACT

[email protected]

8610-13671005510

Robert Chunhua Zhao, Doctor

CONTACT

[email protected]

8610-13701289612

Sponsors and collaborators

Lead sponsor

Cell Energy Life Sciences Group Co. LTD

Industry

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jul 11, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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