Mesenchymal Stem Cells for Immune Non-responder Patients With HIV Infection
NCT05872659 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-05-24
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. Efficacy of human umbilical cord mesenchymal stem cells combined with antiviral therapy in the treatment of AIDS patients with immune non-response.
2. Safety of human umbilical cord mesenchymal stem cells combined with antiviral therapy in AIDS patients with immune non-response.
Participants will receive CD4,CD4/CD8, and RNA viral load tests and will be randomly assigned to either saline or mesenchymal stem cell therapy.
Investigators will evaluate the safety and efficacy of mesenchymal stem cell therapy based on examination results.
Conditions
- AIDS Virus
- Disorder of Immune Reconstitution
Interventions
- OTHER
-
normal saline
iv at D0, D30, D60
- BIOLOGICAL
-
Mesenchymal stem cells
iv at D0, D30, D60
Sponsors & Collaborators
-
Shandong Public Health Clinical Center
collaborator OTHER_GOV -
Shandong Qilu Cell Therapy Engineering Technology Co., Ltd
lead INDUSTRY
Principal Investigators
-
Chenfan liu · Shandong Public Health Clinical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-16
- Primary Completion
- 2025-11-15
- Completion
- 2025-11-15
Countries
- China
Study Locations
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