Evaluation of GvHD Damage on Medullary Mesenchymal Stem Cells

May 23, 2023 updated by: Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Torino, Italy, 10126
        • Recruiting
        • AOU Citta della Salute e della Scienza di Torino
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients (children and adults) developing acute or chronic GvHD after HSCT

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of damage generated by acute or chronic GvHD on the MSCs after HSCT
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2021

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GvHD damage on MSCs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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