NCT05939167

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
25mo left

Started Dec 2023

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Dec 2023Jul 2028

First Submitted

Initial submission to the registry

May 15, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 10, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2028

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

3.6 years

First QC Date

May 15, 2023

Last Update Submit

August 7, 2025

Conditions

AIDS

Outcome Measures

Primary Outcomes (2)

  • Number of participants with side effects in MSCs treatment groups

    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

    at week 12, 24 and 48, evaluate CD4+ T cell counts and compare with baseline

    48 weeks

Secondary Outcomes (1)

  • HIV RNA viral load

    48 weeks

Study Arms (3)

placebo control

PLACEBO COMPARATOR

use saline

Other: saline

mesenchymal stem cells standard treatment

EXPERIMENTAL

transplant mesenchymal stem cells for 3 times

Drug: mesenchymal stem cell

mesenchymal stem cells enhanced treatment

EXPERIMENTAL

transplant mesenchymal stem cells for 6 times

Interventions

mesenchymal stem cellDRUG

Mesenchymal stem cell dose is 0.75-1.0Ă—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).

Also known as: umbilical cord derived MSCs
mesenchymal stem cells standard treatment
salineOTHER

saline is used as placebo in the placebo comparator group

placebo control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing 302 Hospital

Beijing, China

RECRUITING

Beijing YouAn Hospital

Beijing, China

RECRUITING

Shenzhen Third People's Hospital

Shenzhen, China

RECRUITING

The Fifth Hospital of Shijiazhuang

Shijiazhuang, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Fu-Sheng Wang, Doctor

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu-Sheng Wang, Doctor

CONTACT

8610-13671005510fswang302@163.com

Robert Chunhua Zhao, Doctor

CONTACT

8610-13701289612zhaochunhua@vip.163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

July 11, 2023

Study Start

December 10, 2023

Primary Completion (Estimated)

July 10, 2027

Study Completion (Estimated)

July 10, 2028

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)