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| Name | Class |
|---|---|
| Shandong Public Health Clinical Center | OTHER_GOV |
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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:
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.
Highly active antiretroviral therapy (HAART) is an effective means to inhibit virus replication, increase the number of CD4+T lymphocytes and reduce mortality in HIV-infected people. However, it has been found that around 10% - 40% of patients have not achieved ideal immune function reconstruction under the condition of good viral load control and are referred to as"inadequate immunological responders" or "immune non-responders" (INRs).
A series of intervention measures have been proposed for patients with immune non-response, including growth hormone therapy, immunosuppressive therapy, cytokine therapy, traditional Chinese medicine therapy, etc., but there is no specific and effective treatment in clinical practice.
Mesenchymal stem cells (MSCs) are pluripotent stem cells with high self-renewal ability and multi-directional differentiation potential derived from mesoderm. MSCs have considerable therapeutic effects due to their migration, differentiation, immune-modulation, and regeneration abilities. The immunomodulatory effect of mesenchymal stem cells can inhibit the excessive immune activation in patients. At the same time, the paracrine effect of mesenchymal stem cells can also regulate the disordered microenvironment and promote the repair of damaged cells and tissues.
This is a randomised, placebo-controlled, clinical trial to evaluate the safety and feasibility of a 3-doses treatment regimen with MSCs (1 million cells/Kg MSCs, months 0-1-2) in HIV infected adults with immune non-response. Subjects are block randomised (1:1) to receive either MSCs (n=10), or placebo (n=10), as the control treatment. Changes in CD4+Tcount and CD4/8,adverse events, opportunistic infection signs are evaluated as determinants of safety and efficacy of MSCs. Study endpoints are measured along a follow-up period of 12 months, that includes 7 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Participants will receive continuous antiviral therapy and saline placebo (iv, 100 mL) treatment on Day 0,Day30,Day60 and followed up for 48 weeks. |
|
| Treatment group | Experimental | Participants will receive continuous antiviral therapy and Mesenchymal stem cells (1*10^6/kg subject weight, iv, 100 mL) treatment on Day 0,Day30,Day60 and followed up for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline | Other | iv at D0, D30, D60 |
| |
| Mesenchymal stem cells |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CD4+T cell counts | the total CD4+T cell counts compared with CD4 T cell counts at baseline | Change from Baseline at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in CD4/CD8 | the value of CD4/CD8 compared with CD4/CD8 value at baseline | Change from Baseline at 12 months |
| change in RNA viral load | the RNA viral load compared with RNA viral load at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenfan Liu | Contact | 17862958810 | 1780966676@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Chenfan liu | Shandong Public Health Clinical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Public Health Clinical Center | Recruiting | Jinan | Shandong | 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 |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Biological |
iv at D0, D30, D60 |
|
| Change from Baseline at 12 months |
| The incidence of opportunistic infections | Incidence of opportunistic infections throughout the study period | 12 months |
| 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 |