NCT05872659

Brief Summary

The goal of this clinical trial is to explore the effect of mesenchymal stem cell therapy on immune non-responder patients. The main questions it aims to answer are:

  1. 1.Efficacy of human umbilical cord mesenchymal stem cells combined with antiviral therapy in the treatment of AIDS patients with immune non-response.
  2. 2.Safety of human umbilical cord mesenchymal stem cells combined with antiviral therapy in AIDS patients with immune non-response.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2023

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 11, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

April 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

May 24, 2023

Status Verified

April 1, 2023

Enrollment Period

2.6 years

First QC Date

April 11, 2023

Last Update Submit

May 14, 2023

Conditions

AIDS VirusDisorder of Immune Reconstitution

Keywords

HIVmesenchymal stem cellImmune Non-responderCD4AIDSImmune reconstitution

Outcome Measures

Primary Outcomes (1)

  • Change in CD4+T cell counts

    the total CD4+T cell counts compared with CD4 T cell counts at baseline

    Change from Baseline at 12 months

Secondary Outcomes (3)

  • change in CD4/CD8

    Change from Baseline at 12 months

  • change in RNA viral load

    Change from Baseline at 12 months

  • The incidence of opportunistic infections

    12 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

Participants will receive continuous antiviral therapy and saline placebo (iv, 100 mL) treatment on Day 0，Day30，Day60 and followed up for 48 weeks.

Other: normal saline

Treatment group

EXPERIMENTAL

Participants will receive continuous antiviral therapy and Mesenchymal stem cells (1\*10\^6/kg subject weight, iv, 100 mL) treatment on Day 0，Day30，Day60 and followed up for 48 weeks.

Biological: Mesenchymal stem cells

Interventions

normal salineOTHER

iv at D0, D30, D60

Control group
Mesenchymal stem cellsBIOLOGICAL

iv at D0, D30, D60

Treatment group

Eligibility Criteria

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

You may qualify if:

  • Confirmed HIV infection.
  • ≥18 years old, gender unlimited.
  • ≥12 months of continuous antiviral therapy and at least 2 viral loads (3 months or more apart) \< 50 Copies/mL at screening.
  • The antiviral regimen was not changed in the 12 months prior to enrollment.
  • CD4+T lymphocyte count \< 200 μL-1 in patients receiving antiviral therapy for more than 1 year and less than 2 years or \< 350 μL-1 in patients receiving antiviral therapy for ≥ 2 years.
  • Understand and sign the informed consent.

You may not qualify if:

  • Infection with other viruses: HBV-DNA positive, HCV RNA positive, anti-Hav IgM, anti-HDV IgM and anti-HEV IgM positive and ALT \>80 IU/L, anti-TP positive.
  • Active and uncontrollable infection.
  • Malignant tumor or tumor history.
  • Complicated with abnormal function of heart, liver, lung, kidney and other major organs.
  • When the laboratory test satisfies any item (WBC \< 3.5\*10\^9/L; PLT \< 80\*10\^9/L; HGB \< 100 g/L).
  • Drug dependent.
  • Pregnant and lactating women.
  • Severe allergic constitution, or known allergy to the study drug and its components;
  • Accepting immunosuppressants or other immunomodulators (including thymosin) or systemic cytotoxic agents within 6 months prior to screening.
  • Participated in other clinical studies within 3 months prior to this study.
  • patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Public Health Clinical Center

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Saline Solution

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)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Chenfan liu

    Shandong Public Health Clinical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenfan Liu

CONTACT

178629588101780966676@qq.com

Study Design

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

Study Record Dates

First Submitted

April 11, 2023

First Posted

May 24, 2023

Study Start

April 16, 2023

Primary Completion

November 15, 2025

Study Completion

November 15, 2025

Last Updated

May 24, 2023

Record last verified: 2023-04

Locations

CN(1)