COLLECTION AND STORAGE CENTER FOR CLINICAL RESEARCH

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)是临床上可以接受的 非亲缘献血者骨髓或外周血的替代 异体移植。关于UCBU需要回答的问题 移植包括：1)与新生儿捐献者无关的孩子是否可以 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(所有配型成功的同胞和配型无关的供者脐带 到目前为止，血液移植适用于体重不到40岁的患者。 移植物抗宿主病(GvHD)通常是轻微且容易的吗？ 可处理？4)可以容忍多大程度的、什么样的人类白细胞抗原差异？ 5)是否有足够的移植物抗白血病(GVL)效应来防止复发？ 6)免疫重建的过程是什么？为了回答这些问题并 关于脐带血移植的其他问题将需要确定：a) 2至4个收集和储存中心(脐带血库-CBB)至 通过收集、加工、冷冻保存提供必要的资源 并将人脐带血分配给移植 无血缘关系的受者；b)六至八个脐带血移植中心 (CBTC)将遵循脐带血移植的通用方案 干细胞和祖细胞；以及c)医疗协调中心(MCC)，以 管理捐献者搜索，促进提供脐带血单位 并收集和分析来自这些移植的数据。 该计划的目的是加速和监督临床 快速崛起的脐带血替代脐血的研究 供移植的骨髓。

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.