Use of MRI Labeling Technique to Track Mesenchymal Stem Cell Survival in Orthopaedic Conditions (NCT03648463) | Clinical Trial Compass
WithdrawnNot Applicable
Use of MRI Labeling Technique to Track Mesenchymal Stem Cell Survival in Orthopaedic Conditions
Stopped: Investigator left institution
0Started 2019-10-01
Plain-language summary
The primary objective is to determine whether a surgical intervention involving removing of the calcified cartilage cap in patients with Grade II Kellgren-Lawrence osteoarthritis influences the incorporation of labeled bone marrow aspirate concentrate (BMAC)-derived cells within the cartilage regenerate vs labeled BMAC cells delivered after arthroscopy without removing of the calcified cartilaginous layer. The survival and incorporation of the BMAC labeled cells will be evaluated with MRI using the Ferumoxytol infusion stem cell labeling technique. The second arm of the study evaluating cell fate after injecting stem cells under a rotator cuff repair will also be explored.
The secondary objectives are to 1) determine which surgical intervention leads to better clinical outcomes as measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months, and 2) determine who long we can track the labeled-BMAC cells in the knee.
Who can participate
Age range30 Years – 70 Years
SexALL
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Inclusion criteria
✓. Adults aged 30-70 patients with Kellgren grade II-III osteoarthritis,
✓. Symptomatic knee pain greater than 6 months
✓. At least one discrete contained chondral defect
✓. Failed a minimum of 6 weeks of physical therapy
✓. Grossly normal knee alignment: \<5 degrees of varus or valgus alignment
✓. Lesion located on medial or lateral femoral condyle or trochlea
Exclusion criteria
✕. Radiographs demonstrating either no or little osteoarthritis (Kellgren-Lawrence Grade 0 or 1)
✕. Diagnosis of Inflammatory (RA, JIA etc) or infectious arthritis
✕. Malalignment of mechanical axis \> or = 5 degrees of varus/valgus
✕. Cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
✕. The subject is on ongoing specific osteoarthritis drugs such as chondroitin sulphate, diacerein, N-glucosamine, piascledine, capsaicin in the 2 weeks prior to baseline treatment
✕. BMI \> 30
✕. Currently pregnant or planning to become pregnant (no MRI possible).