Stem Cell DonorsHPCDONNCT06905704
Impact of Stem Cell Donation on Unrelated and Related Donors' Health.
An observational study of Stem Cell Donors, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stem Cell Donors
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2023to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: stem cell donors
Who may be able to join
- 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
Who cannot join
- Donors 18 < years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
Claudia Del Fante, +390382503306, c.delfante@smatteo.pv.it
About this study
Official title: 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.
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).
- Conditions
- Stem Cell Donors
- Keywords
- stem cell donors, safety, transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of stem cell donation
The proportion of overall serious adverse reactions/events (number of patient-reactions out of the total number of patients)
Measured: From enrollment to 30 days after stem cell donation
Secondary outcomes (3)
peripheral stem cells analysis
Measurement of blood counts and CD34+ cells pre-donation and in the collected product
Measured: From enrollment to 30 days after stem cell donation
lymphocyte analysis
Cytofluorimetric analysis of lymphocyte subpopulations (CD4, CD8, CD4/8 ratio) at donor enrollment
Measured: From enrollment to 30 days after stem cell donation
CBC analysis
CBC examination at different measurement times
Measured: From enrollment to 30 days after stem cell donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start3 Feb 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell DonorsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Del Fante, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905704
- Sponsor's protocol ID
- HPCDON
- Acronym
- HPCDON
- Status last verified
- Feb 2025
- First submitted
- 21 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective-prospective Observational Monocentric Study Evaluating the Impact of Stem Cell Donation on Unrelated and Related Donors' Health.
- ClinicalTrials.gov ID
- NCT06905704
- Acronym / sponsor ID
- HPCDON / HPCDON
- Conditions
- Stem Cell Donors
- Keywords
- stem cell donors, safety, transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- stem cell donors
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Donors 18 < years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Donors, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Del Fante, MD (+390382503306, c.delfante@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of stem cell donation (time frame: From enrollment to 30 days after stem cell donation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.