Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

NCT ID: NCT05939167

Last Updated: 2025-08-12

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-10

Study Completion Date

2028-07-10

Brief Summary

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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

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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.

Conditions

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AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo control

use saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

saline is used as placebo in the placebo comparator group

mesenchymal stem cells standard treatment

transplant mesenchymal stem cells for 3 times

Group Type EXPERIMENTAL

mesenchymal stem cell

Intervention Type 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).

mesenchymal stem cells enhanced treatment

transplant mesenchymal stem cells for 6 times

Group Type EXPERIMENTAL

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).

Intervention Type DRUG

saline

saline is used as placebo in the placebo comparator group

Intervention Type OTHER

Other Intervention Names

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umbilical cord derived MSCs

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing 302 Hospital

OTHER

Sponsor Role collaborator

Shenzhen Third People's Hospital

OTHER

Sponsor Role collaborator

Fifth Hospital of Shijiazhuang City

OTHER

Sponsor Role collaborator

Beijing YouAn Hospital

OTHER

Sponsor Role collaborator

Cell Energy Life Sciences Group Co. LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Beijing YouAn Hospital

Beijing, , China

Site Status RECRUITING

Shenzhen Third People's Hospital

Shenzhen, , China

Site Status RECRUITING

The Fifth Hospital of Shijiazhuang

Shijiazhuang, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fu-Sheng Wang, Doctor

Role: CONTACT

8610-13671005510

Robert Chunhua Zhao, Doctor

Role: CONTACT

8610-13701289612

Facility Contacts

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Fu-Sheng Wang, Doctor

Role: primary

8610-13671005510

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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