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Pre-clinical Models for Mesenchymal Stem Cell Therapy in Hemophilic Arthropathy

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT05187936
Collaborator
(none)
200
Enrollment
1
Location
15
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hemophilia is a constitutional coagulation disorder responsible for a hemorrhagic phenotype in patients from an early age. Hemarthrosis is one of the most frequent complications in hemophiliacs and leads to the development of severe and early arthropathy, sometimes as early as childhood. To date, there is no curative treatment for these joint disorders and preventive treatments are insufficient to completely prevent joint degradation. Mesenchymal stem cells have been shown to be of therapeutic interest in the management of pathologies such as osteoarthritis and inflammatory arthritis through their anti-inflammatory, regenerative and anti-apoptotic effects. Hemophilic arthropathy is a separate condition at the border of these two diseases Our study aim to show pre-clinical interest of mesenchymal stem cell therapy in hemophilic arthropathy

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Pre-clinical Models for Mesenchymal Stem Cell Therapy in Hemophilic Arthropathy
    Actual Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of surviva [1 day]

      Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.

    2. Evaluation of proliferation [1 day]

      Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.

    3. Evaluation of apoptosis, phenotype, function of cells [1 day]

      Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.

    4. Evaluation of phenotype [1 day]

      Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria:

    • Hemophilia A or B adult patient, with or without arthropathy

    • Heathly control

    Exclusion criteria:

    • Antiinflammatory drug use

    • immunosuppressive treatment or condition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Alexandre THERON, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05187936
    Other Study ID Numbers:
    • RECHMPL21_0640
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    mesenchymal stem cells
    Healthly control
    Additional relevant MeSH terms:
    Joint Diseases
    Hemophilia A
    Hemophilia B

    Study Results

    No Results Posted as of Jan 12, 2022