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| Name | Class |
|---|---|
| Joint Restoration Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Marrow Aspiration Group | Experimental | 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. |
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| Control | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 52 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiographic analysis | Changes in graft status will be analysed using radiographic analysis | 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 |
Inclusion Criteria:
• Patients aged 18-50 with a cartilage defect indicated for treatment with osteochondral allograft
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Yanke, MD | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2021 | Jan 31, 2021 |
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Prospective, Randomized, Single Blind Clinical Trial
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The control group will receive a 0.5cm sham incision over the iliac crest, but bone marrow aspiration will not be performed.
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| Control group incision | Procedure | 0.5cm sham incision over the iliac crest |
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| Post-operative 24 weeks |
| Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: HIPAA Form | Mar 20, 2018 | Dec 30, 2020 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Main Consent Form | Jan 31, 2021 | Jan 31, 2021 | ICF_002.pdf |