Impact of Stem Cell Donation on Unrelated and Related Donors' Health.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stem Cell Donors. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Retrospective-prospective Observational Monocentric Study Evaluating the Impact of Stem Cell Donation on Unrelated and Related Donors' Health.
Overview
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.
Detailed description
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).
Primary outcome measures
- safety of stem cell donation [Time frame: From enrollment to 30 days after stem cell donation]
Secondary outcome measures (3)
- peripheral stem cells analysis [Time frame: From enrollment to 30 days after stem cell donation]
- lymphocyte analysis [Time frame: From enrollment to 30 days after stem cell donation]
- CBC analysis [Time frame: From enrollment to 30 days after stem cell donation]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Donors 18 < years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia
Identifiers
NCT: NCT06905704 · HPCDON