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临床试验/JPRN-UMIN000024291
JPRN-UMIN000024291已完成1 期

Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells - Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells

Department of Hematology and Oncology, Nagoya University Graduate School of Medicine0 个研究点目标入组 6 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
6

研究概览

简要总结

Five adult patients received MSC-CBT, and no adverse events related to intra-BM injection of MSCs were observed. All patients achieved neutrophil, reticulocyte, and platelet recoveries, with median times to recoveries of 21, 35, and 38 days, respectively. Grade II-IV acute GVHD did not develop in MSC-CBT patients. No patients developed chronic GVHD. At 1 year after transplantation, all MSC-CBT patients survived without relapse.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1. Positive for HIV-Ab 2. Administration of gemtuzumab ozogamicin within 6 months 3. In pregnancy or breast-feeding 4. Uncontrolled psychiatric disorder 5. Uncontrolled infectious disease 6. Allergy to drugs for transplant preconditioning or GVHD prophylaxis 7. Re-transplantation within 1 year from the preceding transplantation 8. Doctor's decision

研究者

发起方
Department of Hematology and Oncology, Nagoya University Graduate School of Medicine

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