Transplantation of G-CSF Stimulated Marrow vs Blood

G-CSF 刺激的骨髓移植与血液移植

• 批准号: 7099848
• 负责人: KIRK R Schultz
• 金额: $ 51.67万
• 依托单位: UNIVERSITY OF BRITISH COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-25 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7099848
• 关键词: Canada; blood; bone marrow; clinical research; clinical trials; homologous transplantation; quality of life; stem cells; transplantation

DESCRIPTION (provided by applicant): Allogeneic Blood and Marrow Transplantation (BMT) is a curative therapy performed on over 15,000 individuals per year, according to the IBMTR, at a cost of approximately $3.5 billion dollars annually. Currently, G-CSF primed peripheral blood is the most commonly used donor source for adult recipients of an allogeneic BMT. The Canadian Blood and Marrow Transplantation Group Clinical Trials Network (CBMTG-CTN), which includes all 23 BMT centers in Canada, was established 11 years ago. Until the establishment of the NHLBI/NCI funded BMT CTN in 2001, the CBMTG-CTN, which includes all BMT patients in Canada, was the largest clinical trials group in North America. The CBMTG-CTN performed a definitive randomized trial in 228 patients and established that related G-CSF stimulated peripheral blood (G-PB) is superior in outcome to unstimulated bone marrow in adult BMT recipients (Couban et al., Blood, 2002). Recently, a small study demonstrated that, as a donor source, G-CSF stimulated BM (G-BM) has a significantly lower rate of graft-versus-host disease than does G-PB and affects long term outcome. A large randomized study is required to definitively establish whether G-BM will give a superior recipient outcome compared to G-PB. Currently, the CBMTG-CTN is the only group capable of performing such a trial, and it has the additional advantages of having performed preliminary trials evaluating G-BM as a donor source. The CBMTG-CTN will also utilize excellent NIH and CIHR funded laboratories to correlate immunological outcomes with this study. The health care system in Canada presents unique opportunities to perform comprehensive quality of life evaluations and economic impact studies in conjunction with this trial. This application represents what will be a pivotal study to establish whether G-BM represents the best donor option for BMT. The immunological studies will be used to develop innovative strategies to improve patient outcomes with graft engineering of G-PB. This study will have a worldwide impact on how BMT is performed in the future.

描述（由申请人提供）：根据IBMTR的数据，同种异体血液和骨髓移植（BMT）是对15,000多人进行的治疗疗法，每年的费用约为35亿美元。目前，G-CSF启动外周血是同种异体BMT的成人接受者最常用的供体来源。加拿大血液和骨髓移植组临床试验网络（CBMTG-CTN），其中包括加拿大所有23个BMT中心。直到2001年成立NHLBI/NCI资助的BMT CTN之前，包括加拿大所有BMT患者在内的CBMTG-CTN是北美最大的临床试验组。 CBMTG-CTN对228名患者进行了确切的随机试验，并确定相关的G-CSF刺激的外周血（G-PB）在成年BMT受体中的结果上优于未刺激的骨髓（Couban等人，Couban等，Blood，Blood，2002）。最近，一项小型研究表明，作为供体来源，G-CSF刺激的BM（G-BM）的移植物与宿主疾病的发生率明显低于G-PB，并且会影响长期结果。需要进行大量的随机研究，以确定与G-PB相比，G-BM是否会给予卓越的受体结果。目前，CBMTG-CTN是唯一能够执行此类试验的组，并且它具有在评估G-BM作为捐助者来源的初步试验的其他优势。 CBMTG-CTN还将利用出色的NIH和CIHR资助的实验室将免疫学结果与这项研究相关联。加拿大的卫生保健系统提供了独特的机会，以与该试验结合进行全面的生活质量评估和经济影响研究。该应用程序代表了一项关键研究，以确定G-BM是否代表了BMT的最佳捐助者选择。免疫学研究将用于制定创新策略，以通过G-PB的移植工程来改善患者的结果。这项研究将对未来的BMT进行全球影响。