Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    40
  • sponsor
    Rush University Medical Center
Updated on 25 March 2022

Summary

The goal of this study is to establish if mesenchymal stem cell augmentation improves graft incorporation and to analyze the cytokine environment of the joint after osteochondral allograft transplantation (OCA) with and without intra-articular bone marrow aspirate concentrate (BMAC) injection. Information learned from this study can be used to biochemically compare treatment response and to assess emerging therapeutic options that may positively alter the biochemical environment in patients who suffer from articular cartilage disorders.

Description

Articular cartilage injuries in the knee continue to grow in number as detection and treatment options have advanced. Treatment options, including microfracture, autologous chondrocyte (cells that make cartilage) implantation, osteochondral grafting and meniscus transplantation can hopefully deter the progression of degeneration and have promise to function as disease modifying solutions. Osteochondral allograft transplantation (OCA) has emerged as a preferred method of treating large focal chondral defects as it structurally replaces the cartilage and often involved sub-chondral bone with native hyaline cartilage and bone. The results of OCA are successful with greater than 85% survival at 5-year follow-up. Failure can occur due to a lack of boney integration or low chondrocyte viability. Therefore, anything to enhance the graft augmentation process may be useful in preventing failure. The purpose of this prospective, randomized study is to determine the effect of bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells on improving graft incorporation and preventing failure. The effect of BMAC on the graft and intra-articular knee environment will be evaluated using 3 techniques: computed tomography (CT) imaging, synovial fluid cytokine analysis, and serum biomarker analysis. Information learned from this study can be used to biochemically compare treatment response and to assess emerging therapeutic options that may positively alter the biochemical environment in patients undergoing osteochondral allograft transplantation.

Details
Condition Cartilage Injury
Treatment Autologous bone marrow aspirate will be harvested and concentrated to a bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells and delivered to site of operation, Control group incision
Clinical Study IdentifierNCT04739930
SponsorRush University Medical Center
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

• Patients aged 18-50 with a cartilage defect indicated for treatment with osteochondral
allograft

Exclusion Criteria

Patients with known rheumatoid arthritis, any other inflammatory arthropathy or
synovial tissue disorder
Patient with a known infection or history of infection in the affected knee
Patients with known bipolar osteoarthritis of the knee as determined by the treating
physician, greater than Kellegren-Lawrence Grade 3 on x-ray imaging
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