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

NCT06895889 | Not Yet Recruiting Phase 1 FDA Device

• 1 other identifier: EB-OC-01
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chondral Defect; Osteochondral Defect

Keywords

Abrasion Chondroplasty; Focal Chondra; Osteochondral Defects; Orthobiologics; Cartilage regeneration

Outcome Measures

Primary Outcomes (6)

• Number of adverse event incidents as compared to control

  Number of adverse event incidents based on clinical laboratory and vital signs during the 12-month period post-surgery as compared to control

  12 months

• Adverse event incident rate (% pateint) as compared to control

  Adverse event incident rate (% patient) based on clinical laboratory and vital signs during the 12-month period post-surgery as compared to control

  12 months

• Number of adverse events based on electrocardiogram readout as compared to control

  Number of adverse events based on Electrocardiogram (ECG) readout as compared to control

  Day 1, 1 week post Surgery

• Incident rate of adverse event (% patient) based on electrocardiogram readout as compared to control

  Incident rate of adverse event (% patient) based on Electrocardiogram (ECG) readout as compared to control

  Day 1, 1 week post Surgery

• Report of all adverse events including incidence, timing, severity, and relationship to the treatment

  The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).

  36 months

• Report of secondary surgical interventions

  Any secondary surgical interventions required to treat the target defects (e.g., reoperations, supplemental fixation, or other interventions) will be recorded.

  36 months

Secondary Outcomes (5)

• Patient reported outcome KOOS scores

  5 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

• Patient reported outcome IKDC scores

  5 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

• MRI AMADEUS score

  Screening, 12 months

• MRI MOCART score

  12 months

• Descriptive report of graft integration based on clinical evaluation

  12 months

Study Arms (2)

EB-OC graft

EXPERIMENTAL

This group will receive the EB-OC graft via an arthrotomy procedure. An arthrotomy is an open joint procedure.

Device: EB-OC Graft Implantation

Abrasion Chondroplasty

ACTIVE COMPARATOR

This group will receive abrasion chondroplasty. Abrasion chondroplasty is a minimally invasive procedure.

Procedure: Abrasion chondroplasty

Interventions

EB-OC Graft Implantation DEVICE

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.

EB-OC graft

Abrasion chondroplasty PROCEDURE

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.

Abrasion Chondroplasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female, between 18 and 65 years of age
• Subject's body mass index (BMI) is ≤ 35 kg/m2.
• Subject has up to two symptomatic, full-thickness cartilage defects of the knee femoral condyle with or without bone involvement that are:
• 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
• Classified as International Cartilage Repair Society (ICRS) grade 3 or 4.
• Has baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain \<65 and KOOS Activities of Daily Life \<70.
• Subject is willing and able to provide informed consent and comply with study requirements.
• Subject agrees to actively participate in a strict rehabilitation protocol and follow-up program.
• For women of childbearing potential, subject must have a negative pregnancy test at Screening, cannot be lactating and must be willing to use adequate contraception throughout study participation.
• Note: Adequate contraception methods will include the following: Abstinence, Oral Contraceptives, Barrier Methods (Condoms, IUD's), or surgical sterilization.
• Subject is willing to give up the use of narcotics for 6 months post-surgery and use and record alternative pain medications (e.g., acetaminophen, or narcotic analgesics, if prescribed).
• Note: Post-surgical use of aspirin for clot prevention and narcotics for immediate post-surgical pain are acceptable.

You may not qualify if:

• 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.
• Has osteoarthritis of Kellgren-Lawrence Grade ≥3 as diagnosed on standing radiographs in the index knee.
• Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of bovine origin.
• Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders.
• Current infection or history of infection in the index knee joint.
• Current skin infection of the index knee joint or skin infection of the index knee joint within the past 3 months.
• Osteochondral defect greater than 7 mm in depth.
• Avascular necrosis (AVN) or osteonecrosis (ON).
• Meniscus tears or defects that require concomitant or prior removal of \>50% of meniscus in the index knee.
• Varus or valgus malalignment exceeding 5° in either knee.
• Need for corrective concomitant osteotomy (tibio-femoral or patellofemoral).
• Symptomatic musculoskeletal condition in the lower limbs that could impede efficacy measures in the target knee.

Sponsors & Collaborators

• Epibone, Inc.: lead
• MCRA: collaborator

Study Officials

• Sarindr Bhumiratana, PhD

  Epibone, Inc.

  STUDY DIRECTOR

Central Study Contacts

Jennifer N Jennings

CONTACT

12027423861; jjennings@mcra.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 2:1 ratio to the investigational product or control, with participants randomized to control provided the crossover opportunity for EB-OC graft treatment at 12 months.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: March 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 26, 2025

Record last verified: 2025-03