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OpenTrials
Completed

NCT Number: NCT01879046

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroplasty

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: ARTHROSTEM

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2013
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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