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

Tracking Information
First Received Date ^ICMJE	December 23, 2009
Last Updated Date	December 23, 2009
Start Date ^ICMJE	January 2009
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 23, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: December 23, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Mesenchymal Stromal Cells and Osteoarthritis
Official Title ^ICMJE	Proliferation and Osteogenic Differentiation of Bone Marrow-derived Mesenchymal Stromal Cells From Osteoarthritic Versus Healthy Donors
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.
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 ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: bone marrow aspirates
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
Condition ^ICMJE	Osteoarthritis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	osteoarthritic donors pelvic compartment advanced-stage (Kellgren and Lawrence grade 3 or 4) osteoarthritic donors healthy donors age-matched healthy donors
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	Recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	June 2011
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years to 90 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01038596
Other Study ID Numbers ^ICMJE	HipMSC-Osteoarthritis
Has Data Monitoring Committee	No
Responsible Party	Prof. K.-P.Günther, University Hospital Dresden, Orthopaedic Department
Study Sponsor ^ICMJE	Dresden University of Technology
Collaborators ^ICMJE	German Federal Ministry of Education and Research Center for Regenerative Therapies Dresden (CRTD)
Investigators ^ICMJE	Not Provided
Information Provided By	Dresden University of Technology
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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