NCT05939167

Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Cell Energy Life Sciences Group Co. LTD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• AIDS

Interventions

Type	Name	Description
DRUG	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).
OTHER	saline	saline is used as placebo in the placebo comparator group

Timeline

• Start date: 2023-12-10
• Primary completion: 2027-07-10
• Completion: 2028-07-10
• First posted: 2023-07-11
• Last updated: 2025-08-12

Locations

4 sites across 1 country: China