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

Knee Osteoarthritis Clinical Trial

— ARTHROSTEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879046
• Other study ID #: RC12_0394
• Status: Completed
• Phase: N/A
• First received: May 27, 2013
• Last updated: February 16, 2017
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• arthroplasty
Blood, bone marrow, synovial fluid and Hoffa's fat pad samplings

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Increasing secretion of anti-inflammatory molecules in vitro	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	up to 3 years