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| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
| Shenzhen Third People's Hospital | OTHER |
| Fifth Hospital of Shijiazhuang City | OTHER |
| Beijing YouAn Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo control | Placebo Comparator | use saline |
|
| mesenchymal stem cells standard treatment | Experimental | transplant mesenchymal stem cells for 3 times |
|
| mesenchymal stem cells enhanced treatment | Experimental | transplant mesenchymal stem cells for 6 times |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cell | Drug | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
4. agree not to participate in other studies and not to receive other immunotherapies during the period of participation in this study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fu-Sheng Wang, Doctor | Contact | 8610-13671005510 | fswang302@163.com | |
| Robert Chunhua Zhao, Doctor | Contact | 8610-13701289612 | zhaochunhua@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fu-Sheng Wang, Doctor | Beijing 302 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing 302 Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| OTHER |
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|
|
| saline | Other | saline is used as placebo in the placebo comparator group |
|
| Beijing YouAn Hospital | Recruiting | Beijing | China |
|
| Shenzhen Third People's Hospital | Recruiting | Shenzhen | China |
|
| The Fifth Hospital of Shijiazhuang | Recruiting | Shijiazhuang | China |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D017670 |
| Sodium Compounds |