NCT04739930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

4.9 years

First QC Date

December 24, 2020

Last Update Submit

January 12, 2023

Conditions

Cartilage Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Radiographic analysis

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

  • Computed Tomography (CT) analysis

    Post-operative 24 weeks

Study Arms (2)

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.

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

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.

Procedure: Control group incision

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 operationPROCEDURE

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

Bone Marrow Aspiration Group
Control group incisionPROCEDURE

0.5cm sham incision over the iliac crest

Control

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-50 with a cartilage defect indicated for treatment with osteochondral allograft

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Study Officials

  • Adam Yanke, MD

    Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The control group will receive a 0.5cm sham incision over the iliac crest, but bone marrow aspiration will not be performed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, Randomized, Single Blind Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2020

First Posted

February 5, 2021

Study Start

March 2, 2018

Primary Completion

January 12, 2023

Study Completion

January 12, 2023

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)