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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- CD4+ T cell counts after MSCs transfusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV infection, aged 18-65, both genders
- •CD4+T count less than 500 cells/ul at baseline.
- •No serious AIDS related events.
- •could understand and sign the informed consent form and comply with the requirements of this study.
- •agree not to participate in other studies and not to receive other immunotherapies during the period of participation in this study
排除标准
- •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.
研究组 & 干预措施
placebo control
use saline
干预措施: saline (Other)
mesenchymal stem cells standard treatment
transplant mesenchymal stem cells for 3 times
干预措施: mesenchymal stem cell (Drug)
结局指标
主要结局
CD4+ T cell counts after MSCs transfusion
时间窗: 48 weeks
at week 12, 24 and 48, evaluate CD4+ T cell counts and compare with baseline
Number of participants with side effects in MSCs treatment groups
时间窗: 48 weeks
Investiagte the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after MSCs infusion.
次要结局
- HIV RNA viral load(48 weeks)