Status:
NOT_YET_RECRUITING
EB-OC for the Treatment of Focal Chondral/Osteochondral Defects in the Knee
Lead Sponsor:
Epibone, Inc.
Collaborating Sponsors:
MCRA
Conditions:
Chondral Defect
Osteochondral Defect
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 ...
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/ osteochondr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal if not on long term remission (e.g., at least 5 years or negative biopsy at last exam), except basal cell carcinoma.
- Clinically significant abnormalities in vital signs at the time of screening defined by
- Systolic BP \>140 or \<90 mmHg or diastolic BP \>90 or \<60 mmHg
- Pulse \<60 or \>100 bpm
- Respiratory Rate \<9 or \>20
- Temperature \>99 °F
- Hemoglobin, platelet, white blood cell count, creatinine, aspartate aminotransferase (AST), and alanine aminotransferase (ALT), prothrombin time (PT), and partial thromboplastin time (PTT) below the lower limit of normal or above the upper limit of normal.
- Active infection (e.g., HIV, viral hepatitis, syphilis, cellulitis, respiratory infection, etc.).
- Alcohol and drug (including medication) abuse.
- Subjects with any contraindications to MR imaging.
- Participation in concurrent trials or in previous trial within 90 days of signing informed consent.
- Intra-Operative Exclusion Criteria
- Greater than 2 defects requiring treatment
- A symptomatic defect with greater than 5 mm of bone loss
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06895889
Start Date
January 1 2026
End Date
December 31 2028
Last Update
March 26 2025
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