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Mesenchymal Stromal Cells and Osteoarthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Dresden University of Technology.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Center for Regenerative Therapies Dresden (CRTD)
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01038596
First received: December 23, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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
Osteoarthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • Global Gene expression profile of bone marrow-derived mesenchymal stromal cells from osteoarthritic versus healthy donors [ Time Frame: after msc isolation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

bone marrow aspirates


Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
osteoarthritic donors
pelvic compartment advanced-stage (Kellgren and Lawrence grade 3 or 4) osteoarthritic donors
healthy donors
age-matched healthy donors

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 [%]

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038596

Locations
Germany
University Hospital Dresden, Orthopaedic Department Recruiting
Dresden, Germany, 01307
Contact: Maik Stiehler, MD, PhD     +49 (0)351 458 18188     maik.stiehler@uniklinikum-dresden.de    
Principal Investigator: Maik Stiehler, MD, PhD            
Sponsors and Collaborators
Dresden University of Technology
German Federal Ministry of Education and Research
Center for Regenerative Therapies Dresden (CRTD)
  More Information

No publications provided

Responsible Party: Prof. K.-P.Günther, University Hospital Dresden, Orthopaedic Department
ClinicalTrials.gov Identifier: NCT01038596     History of Changes
Other Study ID Numbers: HipMSC-Osteoarthritis
Study First Received: December 23, 2009
Last Updated: December 23, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:
osteoarthritis, mesenchymal stromal cells, proliferation

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013