An interventional study of 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 and Control group incision in Cartilage Injury, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-01-13.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
A bone marrow aspiration will be performed from the iliac crest. The bone marrow aspirate will be processed using a bone marrow aspirate concentrate (BMAC) harvesting system. The osteochondral allograft plug will then be soaked in the BMAC for a minimum 2 minutes prior to implantation. The remaining BMAC will be placed in the defect site prior to plug implantation.
Procedure: 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
The control group will receive a 0.5cm sham incision over the iliac crest, but bone marrow aspiration will not be performed. The osteochondral allograft plug will not be soaked in BMAC prior to implantation.
Procedure: Control group incision
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
Synovial Fluid Cytokine Measurement
To measure the amount of cytokines and cartilage biomarkers in the synovial fluid of patients undergoing osteochondral allograft transplantation with and without BMAC augmentation at different time points
Time frame: Up to 52 weeks
Radiographic analysis
Changes in graft status will be analysed using radiographic analysis
Time frame: Day 1, Post-operative 2 weeks, 6 weeks, 12, weeks, 24 weeks, 52 weeks
Computed Tomography (CT) analysis
Changes in graft status will be analysed using Computed Tomography (CT) analysis
Time frame: Post-operative 24 weeks
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Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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