NCT06895889

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Epibone, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is 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 as compared to abrasion chondroplasty. Enrollment in this study is expected to occur over 12 months. Subjects will be evaluated for safety and efficacy for 24 months post-surgery. It is anticipated that the study will be completed in approximately 36 months. EB-OC comprising of a living tissue engineered cartilage layer attaching to a bone scaffold. The living tissue engineered cartilage layer is a cartilage-like tissue grown in the lab from an allogeneic (from donor) bone-marrow derived mesenchymal stem cells that have been induced to under cartilage development refered as Drug Substance EB-CMB.

Conditions

• Chondral Defect
• Osteochondral Defect

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-03-26
• Last updated: 2025-03-26

Regulatory

• FDA-regulated device study