EB-OC for the Treatment of Focal Chondral/Osteochondral Defects in the Knee
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEpibone, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Subject is male or female, between 18 and 65 years of age
Subject's body mass index (BMI) is ≤ 35 kg/m2.
Located on the femoral condyles or femoral trochlea
Each between 0.75 and 3 cm2 in area on screening images as confirmed by an independent radiologist
Disqualifiers
Lesions on the opposing surface of the tibia that are classified as ICRS grade 3 or 4.
Lesions on the opposing surface of the patella that are classified as ICRS grade 3 or 4 if a trochlear defect is being treated.
Any existing prosthetic implants in the index knee.
History of knee surgery in the index knee within 6 months prior to screening.
Trial design
Treatments tested in this trial
- EB-OC Graft Implantation
- Abrasion chondroplasty
Treatment groups
36 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Epibone, Inc.
Lead sponsor
MCRA
Collaborator
Source ClinicalTrials.gov