Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06895889
PHASE1/PHASE2

EB-OC for the Treatment of Focal Chondral/Osteochondral Defects in the Knee

Sponsor: Epibone, Inc.

View on ClinicalTrials.gov

Summary

EB-OC is a tissue engineered osteochondral tissue graft comprising of a living tissue engineered cartilage layer attaching to a bone scaffold. The goal of this clinical trial is to learn about in the safety and efficacy of the EB-OC graft in participants who require repair of chondral/osteochondral defects of the knee. The main question it aims to answer is if the EB-OC graft works to regenerate osteochondral tissue comprising of native hyaline cartilage anchors to the regenerated bone. Participants will receive treatment of either the EB-OC Graft implantation in an arthrotomy procedure or abrasion chondroplasty. Researchers will compare results from the EB-OC graft to abrasion chondroplasty to assess overall safety and effectiveness.

Official title: A Prospective, Randomized, Controlled, Open-label, First-in-human Phase I/IIb Study to Evaluate the Safety and Efficacy of the EB-OC Graft in the Repair of Full Thickness Chondral/osteochondral Defects of the Knee

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-01-01

Completion Date

2028-12-31

Last Updated

2025-03-26

Healthy Volunteers

Yes

Interventions

DEVICE

EB-OC Graft Implantation

The implantation of the EB-OC graft is completed via an arthrotomy, which is categorized as a minor surgery and is done on an outpatient basis, which means you can go home the same day. It is completed under general anesthesia and may last between one to two hours.

PROCEDURE

Abrasion chondroplasty

Abrasion chondroplasty is a minimally invasive procedure in which the surgeon uses a rotary burr to scrape off the bone tissue from the surface of the joint.