Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939167
• Other study ID #: 2022YFC2304403
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 10, 2023
• Est. completion date: July 10, 2026

Study information

• Verified date: January 2024
• Source: Cell Energy Life Sciences Group Co. LTD
• Contact: Fu-Sheng Wang, Doctor
• Phone: 8610-13671005510
• Email: fswang302[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 10, 2026
• Est. primary completion date: July 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

2. CD4+T count less than 350 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.

Related Conditions & MeSH terms

• AIDS

Intervention

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

Locations

Country	Name	City	State
China	Beijing 302 Hospital	Beijing
China	Beijing YouAn Hospital	Beijing
China	Shenzhen Third People's Hospital	Shenzhen
China	The Fifth Hospital of Shijiazhuang	Shijiazhuang

Sponsors (5)

Lead Sponsor	Collaborator
Cell Energy Life Sciences Group Co. LTD	Beijing 302 Hospital, Beijing YouAn Hospital, Fifth Hospital of Shijiazhuang City, Shenzhen Third People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	HIV RNA viral load	At week 12, 24 and 48, test HIV RNA viral load in participants' blood using RT-PCR and compare with baseline.	48 weeks