Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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AIDS

Intervention / Treatment
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* Drug: mesenchymal stem cell
* Other: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed HIV infection, aged 18-65, both genders CD4+T count less than 200 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. 4. agree not to participate in other studies and not to receive other immunotherapies during the period of participation in this study Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo control<br>use saline | Other: saline<br>* saline is used as placebo in the placebo comparator group<br>|
| Experimental: mesenchymal stem cells standard treatment<br>transplant mesenchymal stem cells for 3 times | Drug: mesenchymal stem cell<br>* 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).<br>* Other names: umbilical cord derived MSCs;|
| Experimental: mesenchymal stem cells enhanced treatment<br>transplant mesenchymal stem cells for 6 times | Drug: mesenchymal stem cell<br>* 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).<br>* Other names: umbilical cord derived MSCs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |