Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: arthroplasty

• Registration Number: NCT01879046
• Lead Sponsor: Nantes University Hospital

Brief Summary

Articular cartilage can be the seat of many diseases including osteoarthritis and traumatic defaults. The cartilage has no intrinsic ability to repair resulting at long term in function loss in the joints. Currently available treatments are not satisfactory in the long term, the use of mesenchymal stem cells appears to be promising due to their ability to multipotency and immunomodulation properties. This project aims to determine the most appropriate source for regenerative medicine of cartilage stem cells from tissue taken during arthroplasty in patients with osteoarthritis. These cells will be tested for different chondrogenic markers. The success of this project will consider the implementation of a strategy for regenerative medicine in bone and joint diseases.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-17
• Study Start: 2015-10
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients aged over 18 years
• Patients with knee osteoarthritis
• Patients requiring total knee arthroplasty
• Patients who signed the consent form

Exclusion Criteria

• Patients aged less than 18 years
• Major Patients under guardianship
• Pregnant woman
• Infectious pathology or progressive tumor
• Refusal to participate in the study
• State of immunosuppression
• Congenital or acquired malformation resulting in a deformation of the knee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical intervention	arthroplasty	Blood, bone marrow and Hoffa's fat pad samplings during surgical intervention

Primary Outcome Measures

Name	Time	Method
Increased expression of chondrogenic markers	up to 3 years	Increased expression of chondrogenic markers will be Evaluated by different techniques: in vitro: Histology fit for chondrogenic markers, RT-PCR on the following markers aggrecan, type II collagen, Sox9, Comp, type IX collagen; in vivo: In a second step, differentiated MSCs are implanted in vivo after combination with a hydrogel subcutaneously in nude mice. The formation of a neo cartilage tissue will be assessed by histology for type II collagen and aggrecan

Secondary Outcome Measures

Name	Time	Method
Increasing secretion of anti-inflammatory molecules in vitro	up to 3 years	Increasing secretion of anti-inflammatory molecules in vitro will be tested by several techniques: Microfluidic cards (TLDA assays) for the analysis of the expression of genes involved in inflammation and in the secretion of anti-inflammatory molecules Inhibition of proliferation of autologous T cells activated or not Assay for anti-inflammatory and pro-inflammatory molecules Analysis of the expression of surface markers by flow cytometry

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France