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Mesenchymal Stromal Cells and Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01038596
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : April 14, 2017
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Technische Universität Dresden

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

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 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 : January 2009
Primary Completion Date : June 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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

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

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

Biospecimen Retention:   Samples With DNA
bone marrow aspirates

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
pelvic compartment advanced-stage (Kellgren and Lawrence grade 3 or 4, mean 67±6 years) osteoarthritic and age-matched healthy donors

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038596

University Hospital Dresden, Orthopaedic Department
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
German Federal Ministry of Education and Research

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01038596     History of Changes
Other Study ID Numbers: HipMSC-Osteoarthritis
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by Technische Universität Dresden:
osteoarthritis, mesenchymal stromal cells, proliferation

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases