Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, 27100, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT06905704
Impact of Stem Cell Donation on Unrelated and Related Donors' Health.
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.
Recruiting
Interested in participating?
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Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
safety of stem cell donation
Time frame: 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)
Secondary outcomes
-
peripheral stem cells analysis
Time frame: From enrollment to 30 days after stem cell donation
Measurement of blood counts and CD34+ cells pre-donation and in the collected product
-
lymphocyte analysis
Time frame: From enrollment to 30 days after stem cell donation
Cytofluorimetric analysis of lymphocyte subpopulations (CD4, CD8, CD4/8 ratio) at donor enrollment
-
CBC analysis
Time frame: From enrollment to 30 days after stem cell donation
CBC examination at different measurement times
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Other
Registry information
Official study title
Retrospective-prospective Observational Monocentric Study Evaluating the Impact of Stem Cell Donation on Unrelated and Related Donors' Health.
Acronym: HPCDON
Important dates
- Study start
- 2023
- Primary completion
- 2028
- Study completion
- 2029
- First posted
- Apr 1, 2025
- Registry last updated
- Apr 1, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.