search
Back to results

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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
arthroplasty
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis focused on measuring Mesenchymal stem cells, articular cartilage, tissue engineering, immunomodulation, osteo-arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2013
Last Updated
February 16, 2017
Sponsor
Nantes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01879046
Brief Title
Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells
Acronym
ARTHROSTEM
Official Title
Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Mesenchymal stem cells, articular cartilage, tissue engineering, immunomodulation, osteo-arthritis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical intervention
Arm Type
Experimental
Arm Description
Blood, bone marrow and Hoffa's fat pad samplings during surgical intervention
Intervention Type
Procedure
Intervention Name(s)
arthroplasty
Intervention Description
Blood, bone marrow, synovial fluid and Hoffa's fat pad samplings
Primary Outcome Measure Information:
Title
Increased expression of chondrogenic markers
Description
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
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Increasing secretion of anti-inflammatory molecules in vitro
Description
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
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ronan Guillou
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs