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NCT05167188 Clinical Trial

Evaluation of GvHD Damage on Medullary Mesenchymal Stem Cells

Graft Vs Host Disease Clinical Trial

Official title:
Prospective Multicenter Study for the Evaluation of GvHD Damage on Medullary Mesenchymal Stem Cells - GvHD Damage on MSCs

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05167188
Other study ID # GvHD damage on MSCs
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 14, 2021
Est. completion date March 2025

Study information
Verified date May 2023
Source Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Contact Franca Fagioli, MD
Phone +39011313
Email franca.fagioli@unito.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Spontaneous, multicenter, prospective, non-pharmacological study. At the diagnosis of acute or chronic GvHD after HSCT, bone marrow cells will be analysed for MSC content and properties. Bone marrow aspirate will be performed according to usual clinical practise

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers
Gender All
Age group 6 Months to 99 Years
Eligibility Inclusion Criteria: - Patients (children and adults) developing acute or chronic GvHD after HSCT. - Age 6 months- month-99 years, - Landsky-Karnofsky> 70%, - Acute or chronic GvHD needing further immunosuppressive treatment. Exclusion Criteria: - Anything not included in the inclusion criteria.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention

Locations
Country Name City State
Italy AOU Città della Salute e della Scienza di Torino Torino

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of damage generated by acute or chronic GvHD on the MSCs after HSCT Through study completion, an average of 1 year
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