Mesenchymal Stromal Cells and Osteoarthritis

NCT01038596 | Completed

• 1 other identifier: HipMSC-Osteoarthritis
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

osteoarthritis, mesenchymal stromal cells, proliferation

Outcome Measures

Primary Outcomes (1)

• Global Gene expression profile of bone marrow-derived mesenchymal stromal cells from osteoarthritic versus healthy donors

  after msc isolation

Secondary Outcomes (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

Study Arms (2)

osteoarthritic donors

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

healthy donors

age-matched healthy donors

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• indication for hip THR
• primary osteoarthritis of the hip
• Patient's consent

You may not qualify if:

• secondary osteoarthritis of the hip
• Any malignancies
• infectious disease
• rheumatic disease
• osteoporosis
• Any additional serious disease complicating the participation in this study

Sponsors & Collaborators

• Technische Universität Dresden: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

University Hospital Dresden, Orthopaedic Department

Dresden, 01307, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

bone marrow aspirates

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 24, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

DE (1)