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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05187936
Other study ID # RECHMPL21_0640
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date December 31, 2022

Study information

Verified date October 2021
Source University Hospital, Montpellier
Contact Alexandre THERON, MD
Phone 467336519
Email a-theron@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Hemophilia A or B adult patient, with or without arthropathy - Heathly control Exclusion criteria: - Antiinflammatory drug use - immunosuppressive treatment or condition

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of surviva 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. 1 day
Primary Evaluation of proliferation 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. 1 day
Primary Evaluation of apoptosis, phenotype, function of cells 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. 1 day
Primary Evaluation of phenotype 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. 1 day
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