Clincosm LogoSign in Get a demo

Mesenchymal Stromal Cells and Osteoarthritis

Sponsor
Technische Universität Dresden (Other)
Overall Status
Completed
CT.gov ID
NCT01038596
Collaborator
German Federal Ministry of Education and Research (Other)
30
Enrollment
1
Location
95
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Osteoarthritis (OA) is one of the most frequent musculoskeletal disorders and represents the main indication for total joint arthroplasty. Multipotent mesenchymal stromal cells (MSCs) can be easily isolated and culture expanded from bone marrow aspirates and provide an excellent source of progenitor cells for cell-based regeneration strategies due to their ex vivo differentiation and proliferation capacity. Although there are hints that MSCs derived from OA patients may exhibit altered function the role of MSCs with respect to disease development and progression of OA is not clearly understood to date. To assess whether advanced-stage OA affects MSCs' suitability for musculoskeletal regenerative therapy, in the present study, we compare proliferation and differentiation potential of MSCs from osteoarthritic versus healthy donors.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Clinical data (range of motion of lower limb joints, sociodemographic score dataset, WOMAC score, EQ-5D score, Harris Hip Score, radiological evaluation (OA group only), routine laboratory parameters, and bone metabolism parameters)

    Osteogenic, chondrogenic, and adipogenic differentiation is proofed qualitatively by cell staining

    osteogenic, chondrogenic and adipogenic marker gene expression analysis using quantitative real-time RT-PCR

    cell-specific alkaline phosphatase (ALP) activity assay

    large-scale gene expression profile

    Fluorescence-activated cell sorting (FACS)- CD44, CD105 (SH2; endoglin), CD106 (vascular cell adhesion molecule; VCAM-1), CD166, CD29, CD73 (SH3 and SH4), CD90 (Thy-1), CD117, STRO-1 and Sca-1 [%]

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Proliferation and Osteogenic Differentiation of Bone Marrow-derived Mesenchymal Stromal Cells From Osteoarthritic Versus Healthy Donors
    Study Start Date :
    Jan 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    osteoarthritic donors

    pelvic compartment advanced-stage (Kellgren and Lawrence grade 3 or 4) osteoarthritic donors
    healthy donors

    age-matched healthy donors

    Outcome Measures

    Primary Outcome Measures

    1. Global Gene expression profile of bone marrow-derived mesenchymal stromal cells from osteoarthritic versus healthy donors [after msc isolation]

    Secondary Outcome Measures

    1. Flow cytometric analysis of cell surface antigens, Alkaline phosphatase activity, DNA content as measure for cellular proliferation [variable 2 days up to 21 days after msc cultivation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • indication for hip THR

    • primary osteoarthritis of the hip

    • Patient's consent

    Exclusion Criteria:

    • secondary osteoarthritis of the hip

    • Any malignancies

    • infectious disease

    • rheumatic disease

    • osteoporosis

    • Any additional serious disease complicating the participation in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Dresden, Orthopaedic Department Dresden Germany 01307

    Sponsors and Collaborators

    • Technische Universität Dresden
    • German Federal Ministry of Education and Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Technische Universität Dresden
    ClinicalTrials.gov Identifier:
    NCT01038596
    Other Study ID Numbers:
    • HipMSC-Osteoarthritis
    First Posted:
    Dec 24, 2009
    Last Update Posted:
    Apr 14, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Technische Universität Dresden
    osteoarthritis, mesenchymal stromal cells, proliferation
    Additional relevant MeSH terms:
    Osteoarthritis

    Study Results

    No Results Posted as of Apr 14, 2017