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

Hemophilia A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05187936
• Other study ID #: RECHMPL21_0640
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arthropathy
• Hemophilia A
• Hemophilia B
• Joint Diseases

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