CClinicalTrials.gg
RecruitingNCT06905704HPCDONUpdated Apr 1, 2025

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

An observational study in Stem Cell Donors, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Stem Cell Donors

Keywords

  • stem cell donors, safety, transplantation
03

In context

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

stem cell donors

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

Exclusion Criteria:

  • Donors 18 \< years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. safety of stem cell donation

    The proportion of overall serious adverse reactions/events (number of patient-reactions out of the total number of patients)

    Time frame: From enrollment to 30 days after stem cell donation

Secondary outcomes

  1. peripheral stem cells analysis

    Measurement of blood counts and CD34+ cells pre-donation and in the collected product

    Time frame: From enrollment to 30 days after stem cell donation

  2. lymphocyte analysis

    Cytofluorimetric analysis of lymphocyte subpopulations (CD4, CD8, CD4/8 ratio) at donor enrollment

    Time frame: From enrollment to 30 days after stem cell donation

  3. CBC analysis

    CBC examination at different measurement times

    Time frame: From enrollment to 30 days after stem cell donation

07

Study locations

1 of 1 sites recruiting
  • Fondazione IRCCS Policlinico San Matteo di Pavia
    Pavia, 27100, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06905704
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Responsible party
Claudia Del Fante (MD, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
Apr 1, 2025
Start date
Feb 3, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Jan 31, 2029 (estimated)
Last update
Apr 1, 2025

Study contacts

Claudia Del Fante, MD
Contact
c.delfante@smatteo.pv.it
+390382503306

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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