Five-Week, Multi-center, Phase I Clinical Trial to Evaluate Safety of Homeo-GH After Intra Venus Administration for the Treatment of Graft Versus Host Disease Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- To evaluate number of paticipants with adverse events
研究概览
简要总结
Official Title: Five-Week, Multi-center, Phase I Clinical Trial to Evaluate Safety of Homeo-GH after Intra Venus Administration for the Treatment of Graft versus Host Disease Patients
Sponsor: HomeoTherapy Co.,Ltd
Study Design: Single Group, Open Label, 5 Week, Safety Study
This study is designed to evaluate the safety of ex-vivo cultured adult human clonal mesenchymal stem cells (cMSC) derived from human bone marrow in subjects experiencing acute or chronic graft-versus-host disease (GVHD).
Study Type: Interventional
详细描述
Allogeneic MSCs being used in current human clinical trials are nonclonal, i.e., such MSCs may have other types of cells in the final stem cell product. Some concerns exist about the heterogeneity of these nonclonal MSCs that are isolated and expanded by the conventional density-gradient centrifugation method. Recently, we developed a new protocol, called the subfractionation culturing method (SCM), to generate single-cell-derived clonal MSC (cMSC) lines from whole bone marrow aspirate without employing any centrifugation step for mononuclear cells and enzyme treatment process. This method allowed us to rapidly establish single-cell-derived human clonal MSC (hcMSC) lines from raw bone marrow aspirates and to establish a library of these hcMSC lines (Song et al., 2008).
The goal of this study is to evaluate the safety of allogeneic cMSCs established by the SCM and manufactured in GMP facility. This phase I clinical trial is a multicenter, single dose study of cMSC (1 x 10e6 cMSCs/Kg recipient's bodyweight). Clonal MSCs will be infused to acute or chronic GVHD patients via an intravenous injection. Every patients will receive the same treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained from patient
- •Patients with ages greater than 18 years
- •Neutrophill count > 1,000 cells/mm3
- •Adequated cardiac function with no evidence of cardiac disease
- •Patients who had complete remission after bone marrow transplantation
- •Patients who can sign an informed consent form by him- or her-self or legal representative
排除标准
- •Patients with unstable transplant after bone marrow transplantation
- •Patients with unstable vital sign
- •Patients with positive penicillin skin test
- •Patients who had transplantation to treat solid tumor
- •Patients with bacterial, viral or fungal infection not being controlled by the adequate treatment (more than moderate infection)
- •Patients who, in the investigator's point of view, are not in proper state for the treatment
结局指标
主要结局
To evaluate number of paticipants with adverse events
时间窗: Within the first 5 week
Aderse Events were record relationship with Investigational Product * Not related * Unlikely * Possible * Probable * High probable The severity of adverse events were graded refer to CTCAE (Common Terminology Criteria for Adverse Events) Ver.4.0
次要结局
- GVHD clinical response(Within the first 5 week)