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Completed

NCT Number: NCT04739930

Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation

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.

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Key information

Conditions

Cartilage Injury

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Patients with known bipolar osteoarthritis of the knee as determined by the treating physician, greater than Kellegren-Lawrence Grade 3 on x-ray imaging
  • Patient with a known infection or history of infection in the affected knee

Treatment and study plan

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

Control group incision

Procedure

0.5cm sham incision over the iliac crest

Primary outcomes

  1. Synovial Fluid Cytokine Measurement

    Time frame: Up to 52 weeks

    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

Other outcomes

  1. Radiographic analysis

    Time frame: Day 1, Post-operative 2 weeks, 6 weeks, 12, weeks, 24 weeks, 52 weeks

    Changes in graft status will be analysed using radiographic analysis

  2. Computed Tomography (CT) analysis

    Time frame: Post-operative 24 weeks

    Changes in graft status will be analysed using Computed Tomography (CT) analysis

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Joint Restoration Foundation

Registry information

Official study title

Prospective, Randomized, Single Blind Clinical Trial to Investigate the Impact of Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2021
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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