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OpenTrials
Completed

NCT Number: NCT01038596

Mesenchymal Stromal Cells and Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Dresden, Orthopaedic Department

Dresden, 01307, Germany

About this study

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 [%]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: after msc isolation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

Proliferation and Osteogenic Differentiation of Bone Marrow-derived Mesenchymal Stromal Cells From Osteoarthritic Versus Healthy Donors

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2009
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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