Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation
Condition: Cartilage Injury
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): 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
Intervention type(s): Procedure; Procedure
Intervention description(s): Autologous bone marrow aspirate will be processed and concentrated to a bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells and delivered to the site of operation in the treatment group; 0.5cm sham incision over the iliac crest
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, Single Blind Clinical Trial
Masking: Single (Participant)
Primary purpose: Treatment