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

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ClinicalTrials.gov Identifier: NCT01879046
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE May 27, 2013
First Posted Date  ICMJE June 17, 2013
Last Update Posted Date February 17, 2017
Study Start Date  ICMJE October 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
Increased expression of chondrogenic markers [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01879046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
Increasing secretion of anti-inflammatory molecules in vitro [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells
Official Title  ICMJE Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Procedure: arthroplasty
Blood, bone marrow, synovial fluid and Hoffa's fat pad samplings
Study Arms  ICMJE Experimental: Surgical intervention
Blood, bone marrow and Hoffa's fat pad samplings during surgical intervention
Intervention: Procedure: arthroplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2017)
35
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2013)
30
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01879046
Other Study ID Numbers  ICMJE RC12_0394
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr Ronan Guillou Nantes University Hospital
PRS Account Nantes University Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP