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

NCT01879046 | Completed

• 1 other identifier: RC12_0394
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Mesenchymal stem cells; articular cartilage; tissue engineering; immunomodulation; osteo-arthritis

Outcome Measures

Primary Outcomes (1)

• Increased expression of chondrogenic markers

  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

  up to 3 years

Secondary Outcomes (1)

• Increasing secretion of anti-inflammatory molecules in vitro

  up to 3 years

Study Arms (1)

Surgical intervention

EXPERIMENTAL

Blood, bone marrow and Hoffa's fat pad samplings during surgical intervention

Procedure: arthroplasty

Interventions

arthroplasty PROCEDURE

Blood, bone marrow, synovial fluid and Hoffa's fat pad samplings

Surgical intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Dr Ronan Guillou

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 17, 2013
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

FR (1)