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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01879046
First received: May 27, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Procedure: arthroplasty

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Increased expression of chondrogenic markers [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

    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:
  • Increasing secretion of anti-inflammatory molecules in vitro [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical intervention
Blood, bone marrow and Hoffa's fat pad samplings during surgical intervention
Procedure: arthroplasty
Blood, bone marrow, synovial fluid and Hoffa's fat pad samplings

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879046

Contacts
Contact: Claire Vinatier claire.vinatier@univ-nantes.fr
Contact: Jérôme Guicheux jerome.guicheux@inserm.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France
Contact: Claire Vinatier         
Principal Investigator: Dr Ronan Guillou         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Dr Ronan Guillou Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01879046     History of Changes
Other Study ID Numbers: RC12_0394
Study First Received: May 27, 2013
Last Updated: January 7, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Mesenchymal stem cells
articular cartilage
tissue engineering
immunomodulation
osteo-arthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014