Retrospective-prospective Observational Monocentric Study Evaluating the Impact of Stem Cell Donation on Unrelated and Related Donors' Health.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- safety of stem cell donation
研究概览
简要总结
Haematopoietic stem cell donation represents a unique chance for curing patients affected with onchohaematologic and inherited diseases.If a related donor is unavailable a unrelated donor must be used. For both categories an accurate physical and laboratory examination is mandatory to establish the eligibility to bone marrow or peripheral blood stem cell collection since side effects related to donation may occur. To ensure high standards of safety and satisfaction of unrelated stem cells donors dedicated guidelines are available. On the other hand, there is no unambiguous guidance on the management of the related donor and published data on donation and long term follow-up are scarce.
详细描述
The study, for the retrospective part, aims to report the experience in family and registry donor management at Transfusion Service from 2016 to 2022 (enrollment, stem cell donation, 30-day follow-up) and, for the prospective part, to continue monitoring on donors who will be enrolled in the next five years (2023 to 2028).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family donors ≥18 years referred by the Hematology and Oncohematology Transplant Center Pediatric of the Foundation of Centro Donatori -SIMT, following the national and international guidelines after medical evaluation
- •Volunteer donors from IBMDR registry ≥18 years, following the national and international guidelines after medical evaluation
排除标准
- •Donors 18 < years
结局指标
主要结局
safety of stem cell donation
时间窗: From enrollment to 30 days after stem cell donation
The proportion of overall serious adverse reactions/events (number of patient-reactions out of the total number of patients)
次要结局
- CBC analysis(From enrollment to 30 days after stem cell donation)
- peripheral stem cells analysis(From enrollment to 30 days after stem cell donation)
- lymphocyte analysis(From enrollment to 30 days after stem cell donation)
研究者
Claudia Del Fante
MD
Fondazione IRCCS Policlinico San Matteo di Pavia