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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 36 months
Patient reported outcome KOOS scores
KOOS scores which assesses Pain, Symptoms, Activities of Daily Living, Sport and Recreation Function, and Quality of Life. Score of 0-100 with zero being worst and 100 being best outcome
Time frame: 5 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Patient reported outcome IKDC scores
IKDC Score (Subjective Knee Evaluation, Evaluator Global Assessment and Patient Global Assessment). Score of 0-100 with zero being worst and 100 being best outcome
Time frame: 5 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
MRI AMADEUS score
MRI AMADEUS score of the treated defect at Screening. Score 0-100 with 0 represents worst case cartilage defect and 100 represents best intact cartilage and bone
Time frame: Screening, 12 months
MRI MOCART score
MRI MOCART scoring of the treated defect. Score ranging from 0-100 with 0 being worst and 100 being best.
Time frame: 12 months
Descriptive report of graft integration based on clinical evaluation
Descriptive clinical evaluation of graft integration based on CT image.
Time frame: 12 months
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