Clinical trial NCT01038596: Mesenchymal Stromal Cells and Osteoarthritis
Official title: Proliferation and Osteogenic Differentiation of Bone Marrow-derived Mesenchymal Stromal Cells From Osteoarthritic Versus Healthy Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: osteoarthritis, mesenchymal stromal cells, proliferation
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2009-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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 \[%\]

Eligibility 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

Primary outcomes:
measure: Global Gene expression profile of bone marrow-derived mesenchymal stromal cells from osteoarthritic versus healthy donors
timeFrame: after msc isolation
Secondary outcomes:
measure: Flow cytometric analysis of cell surface antigens, Alkaline phosphatase activity, DNA content as measure for cellular proliferation
timeFrame: variable 2 days up to 21 days after msc cultivation
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Dresden, Orthopaedic Department
Study officials:
References: