NCT00823316已完成1 期
Phase 1/2 Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells Infusion for Promotion of Engraftment and Prevention of an Graft Rejection and Graft-versus-Host Disease After Unrelated Hematopoietic Stem Cell Transplantation.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- - Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and prevention of graft rejection and Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for children with acute leukemia.
详细描述
- Hematopoietic stem cell transplantation (HSCT) is a procedure in which progenitor cells capable of reconstituting normal bone marrow function are administered to a patient. This procedure has been used to treat adults and children with life-threatening hematological malignancies and congenital immunodeficiency disorders.
- In HSCT, therapeutic goal is an elimination of disease and enrichment of regenerating capacity to achieve engraftments resulting in continued generation of functional blood elements from the engrafted living cells. Transplantation of unrelated hematopoietic stem cells originating either from adult bone marrow or from peripheral blood often leads to graft-versus host-disease (GvHD), opportunistic infections and graft failure after transplantation.
- In HSCT, MSC have been used as a therapy for GvHD and other complications. The aim of MSC infusions in HSCT is to use the cells' immunomodulatory effects to promote engraftment and to reduce the immunological reactions giving rise to GvHD.
- There is a growing interest in co-transplantation of MSC and HSC to improve the donor outcome in the unrelated HSCT condition.
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
- None
入排标准
- 年龄范围
- 2 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 2~19 years old with plan to have unrelated hematopoietic stem cell transplantation with acute leukemia
- •Patient never has an experience of hematopoietic stem cell transplantation
- •Patient must have an acute leukemia with a complete remission.
- •Patients must have an ECOG 0~
- •No moderate or sever organ dysfunction : Ejection fraction > 45%; Creatinine <2.0 mg/ml; Serum bilirubin < 2 mg/ml; AST/ALT < 200 IU/L.
- •Patient must not have an transplantation with different source of hematopoietic stem cell such as bone marrow and cord blood.
- •Patient must not have an infection needed an administration of non-oral antibiotics.
- •No active severe infection derived form virus or fungus.
- •Each patient / patient's guardian must sign written informed consent.
排除标准
- •Patient has previously received hematopoietic stem cell transplantation.
- •Patient plans to have a related hematopoietic stem cell transplantation.
- •Patient has a severe internal disease.
- •Patient has enrolled another clinical trial study within last 4 weeks.
研究组 & 干预措施
2
Experimental
at a dose of 5x1,000,000 hMSC/kg
干预措施: Human umbilical cord blood-derived mesenchymal stem cells (Biological)
1
Experimental
at a dose of 1x1,000,000 hMSC/kg
干预措施: Human umbilical cord blood-derived mesenchymal stem cells (Biological)
结局指标
主要结局
- Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate
时间窗: 28 and 100 days
次要结局
- - AGVHD grade(100 days)
研究者
研究点 (1)
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