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COLLECTION AND STORAGE CENTERS FOR CLINICAL RESEARCH

临床研究的收集和储存中心

基本信息

批准号：
6356156
负责人：
JOANNE KURTZBURG
金额：
--
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
1996
资助国家：
美国
起止时间：
1996-09-30 至 2001-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6356156
关键词：
blood banks cell transplantation clinical research graft versus host disease hematopoietic stem cells hematopoietic tissue transplantation histocompatibility homologous transplantation human subject umbilical cord

项目摘要

This study is designed to determine if stem and progenitor cells from umbilical cord blood units (UCBUs) are a clinically acceptable alternative to those from marrow or peripheral blood for unrelated-donor allogeneic transplantation. Questions to be answered about UCBU transplantation include: 1) can children unrelated to the neonate-donors be transplanted with a graft failure rate no greater than 5-10 percent? 2) can adults and larger children (>40 Kg) also be transplanted successfully (all successful matched sib and matched unrelated-donor cord blood transplants to date have been for patients weighing less than 40 Kg)? 3) is graft-vs-host disease (GvHD) usually mild and easily manageable? 4) how much and what kind of HLA disparity can be tolerated? 5) is there enough graft-vs-leukemia (GvL) effect to prevent relapse? 6) what is the course of immune reconstitution? To answer these and other questions about UCBU transplantation will require establishing: a) two to four collection and storage centers (Cord Blood Banks - CBBs) to provide the necessary resource by collecting, processing, cryopreserving and distributing human umbilical cord blood for transplantation to unrelated recipients; b) six to eight Cord Blood Transplant Centers (CBTCs) to follow common protocols for the transplantation of cord blood stem and progenitor cells; and c) a Medical Coordinating Center (MCC) to manage donor searches, facilitate the provision of cord blood units for transplants and collect and analyze data from these transplants. The purpose of this program is to accelerate and oversee clinical research in the rapidly emerging use of umbilical cord blood in place of marrow for transplantation.

这项研究旨在确定干细胞和祖细胞是否来自脐带血单位（UCBU）是临床上可接受的非亲缘供者骨髓或外周血的替代品同种异体移植关于UCBU的问题移植包括：1）与供体无关的儿童移植失败率不超过5%-10%？ 2)成人和较大的儿童（>40公斤）也可以移植吗？成功（所有成功匹配的同胞和匹配的无关供体脐带迄今为止，血液移植的对象是体重低于40岁的患者。公斤）？ 3)移植物抗宿主病（GvHD）通常是轻微的，可管理的？ 4)可以容忍多少和什么样的HLA差异？ 5)是否有足够的移植物抗白血病（GvL）效应来防止复发？ 6)免疫重建的过程是怎样的？为了回答这些问题，关于UCBU移植的其他问题需要确定：a） 2至4个采集和储存中心（脐带血库-CBB），通过采集、加工、冷冻保存，并分发人类脐带血用于移植，不相关的接受者; B）六至八个脐带血移植中心（CBTC）遵循脐带血移植的常见协议干细胞和祖细胞;以及c）医疗协调中心（MCC），管理捐赠者搜寻，促进脐带血单位的提供，并收集和分析这些移植的数据。该计划的目的是加速和监督临床研究迅速兴起的使用脐带血代替骨髓移植。