Impact of Stem Cell Donation on Unrelated and Related Donors' Health.

Retrospective-prospective Observational Monocentric Study Evaluating the Impact of Stem Cell Donation on Unrelated and Related Donors' Health.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06905704

Acronym

HPCDON

Enrollment

400

Registered

2025-04-01

Start date

2023-02-03

Completion date

2029-01-31

Last updated

2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stem Cell Donors

Keywords

stem cell donors, safety, transplantation

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
safety of stem cell donation	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

Measure	Time frame	Description
peripheral stem cells analysis	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	From enrollment to 30 days after stem cell donation	Cytofluorimetric analysis of lymphocyte subpopulations (CD4, CD8, CD4/8 ratio) at donor enrollment
CBC analysis	From enrollment to 30 days after stem cell donation	CBC examination at different measurement times

Countries

Italy

Contacts

Primary ContactClaudia Del Fante, MD

c.delfante@smatteo.pv.it+390382503306

Outcome results