Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation

NCT ID: NCT04739930

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-02
• Study Completion Date: 2023-01-12

Brief 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.

Conditions

Cartilage Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Control group incision

Intervention Type: PROCEDURE

0.5cm sham incision over the iliac crest

Interventions

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

Intervention Type: PROCEDURE

Control group incision

0.5cm sham incision over the iliac crest

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joint Restoration Foundation

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Yanke, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form: HIPAA Form

View Document

Document Type: Informed Consent Form: Main Consent Form

View Document

Other Identifiers

17121805

Identifier Type: -

Identifier Source: org_study_id