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临床试验/NCT00212407
NCT00212407终止早期 1 期

New York Blood Center National Cord Blood Program

New York Blood Center1 个研究点 分布在 1 个国家目标入组 4,476 人开始时间: 1993年2月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
终止
入组人数
4,476
试验地点
1
主要终点
Treatment Related Mortality

研究概览

简要总结

Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor. The outcome of transplantation is obtained to assess cord blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.

详细描述

Umbilical cord blood donated to the New York Blood Center's National Cord Blood Program is collect, tested, processed, cryoprotected and frozen in liquid nitrogen for possible future transplantation to anyone who needs it. The Program has operated under a FDA IND exemption since 1996 and is licensed as a tissue bank by the New York State Department of Health.

Candidates for transplant are patients who disease requires bone marrow transplantation but who do not have a suitable related bone marrow donor. Most patients are those with high risk of refractory leukemia, lymphoma, myelodysplasia, severe aplastic anemia and certain genetic hematologic, immunologic and metabolic diseases.

Patients are treated at bone marrow transplant centers in the United States and in other countries with active marrow transplant programs. Because the NYBC Program operates under IND, patients must sign an informed consent for cord blood transplantation.

Transplant centers report on the transplant procedure (including immediate complications) and on transplant outcome at 3, 6 and 12 months post-transplant and annually thereafter. Data report to the New York Blood Center includes information about the patient's disease and pre-transplant conditioning regimen and post-transplant endpoints, primarily myeloid and platelet engraftment, transplant related mortality, overall survival, acute and chronic graft vs. host disease, relapse and other post-transplant complications such as infectious disease. The outcome data is used to assess safety and efficacy and will be used to apply for a license from the FDA.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Candidates for bone marrow transplantation

排除标准

  • 未提供

结局指标

主要结局

Treatment Related Mortality

时间窗: released prior to 12-1-2012

Engraftment

时间窗: released prior to 12-1-2012

Survival

时间窗: released prior to 12-1-2012

次要结局

  • Relapse(released prior to 12-1-2012)
  • Graft vs. Host Disease(released prior to 12-1-2012)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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