Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation

Prospective, Randomized, Single Blind Clinical Trial to Investigate the Impact of 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.

Study Overview

• Status: Completed
• Conditions: Cartilage Injury
• Intervention / Treatment: 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; Procedure: Control group incision

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bone Marrow Aspiration Group; 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; 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
Sham Comparator: Control; 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; 0.5cm sham incision over the iliac crest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	Post-operative 24 weeks

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Joint Restoration Foundation
• Investigators: Principal Investigator: Adam Yanke, MD, Faculty

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17121805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No