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

Retrospective-prospective Observational Monocentric Study Evaluating the 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.

Study Overview

• Status: Recruiting
• Conditions: Stem Cell Donors

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).

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Claudia Del Fante, MD; Phone Number: +390382503306; Email: c.delfante@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo di Pavia
    • Contact: Claudia Del Fante; Phone Number: +390382503306; Email: c.delfante@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

stem cell donors

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of stem cell donation	The proportion of overall serious adverse reactions/events (number of patient-reactions out of the total number of patients)	From enrollment to 30 days after stem cell donation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peripheral stem cells analysis	Measurement of blood counts and CD34+ cells pre-donation and in the collected product	From enrollment to 30 days after stem cell donation
lymphocyte analysis	Cytofluorimetric analysis of lymphocyte subpopulations (CD4, CD8, CD4/8 ratio) at donor enrollment	From enrollment to 30 days after stem cell donation
CBC analysis	CBC examination at different measurement times	From enrollment to 30 days after stem cell donation

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: stem cell donors, safety, transplantation
• Other Study ID Numbers: HPCDON

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No