Chondral DefectPhase 1/2NCT06895889
EB-OC for the Treatment of Focal Chondral/Osteochondral Defects in the Knee
A Phase 1/2 study testing EB-OC Graft Implantation and Abrasion chondroplasty in people with Chondral Defect and Osteochondral Defect, run by Epibone, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chondral Defect, Osteochondral Defect
- What is being tested?
- EB-OC Graft Implantation and Abrasion chondroplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read 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/ 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
- Being tested
- EB-OC Graft Implantation, Abrasion chondroplasty
- Keywords
- Abrasion Chondroplasty, Focal Chondra, Osteochondral Defects, Orthobiologics, Cartilage regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-OC Graft ImplantationDevice
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 chondroplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| EB-OC graft | Experimental | This group will receive the EB-OC graft via an arthrotomy procedure. An arthrotomy is an open joint procedure. Receives: Device: EB-OC Graft Implantation |
| Abrasion Chondroplasty | Active comparator | This group will receive abrasion chondroplasty. Abrasion chondroplasty is a minimally invasive procedure. Receives: Procedure: Abrasion chondroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 36 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 months
Descriptive report of graft integration based on clinical evaluation
Descriptive clinical evaluation of graft integration based on CT image.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondral DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epibone, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Sarindr Bhumiratana, PhD, Study director, Epibone, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895889
- Sponsor's protocol ID
- EB-OC-01
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06895889
- Acronym / sponsor ID
- EB-OC-01
- Conditions
- Chondral Defect, Osteochondral Defect
- Keywords
- Abrasion Chondroplasty, Focal Chondra, Osteochondral Defects, Orthobiologics, Cartilage regeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Epibone, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| EB-OC graft | Experimental | Device: EB-OC Graft ImplantationThis group will receive the EB-OC graft via an arthrotomy procedure. An arthrotomy is an open joint procedure. |
| Abrasion Chondroplasty | Active comparator | Procedure: Abrasion chondroplastyThis group will receive abrasion chondroplasty. Abrasion chondroplasty is a minimally invasive procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EB-OC Graft ImplantationThe 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. | Device | EB-OC graft |
| Abrasion chondroplastyAbrasion 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. | Procedure or surgery | Abrasion Chondroplasty |
Primary outcome
Number of adverse event incidents as compared to control
Time frame: 12 months
Number of adverse event incidents based on clinical laboratory and vital signs during the 12-month period post-surgery as compared to control
Adverse event incident rate (% pateint) as compared to control
Time frame: 12 months
Adverse event incident rate (% patient) based on clinical laboratory and vital signs during the 12-month period post-surgery as compared to control
Number of adverse events based on electrocardiogram readout as compared to control
Time frame: Day 1, 1 week post Surgery
Number of adverse events based on Electrocardiogram (ECG) readout as compared to control
Incident rate of adverse event (% patient) based on electrocardiogram readout as compared to control
Time frame: Day 1, 1 week post Surgery
Incident rate of adverse event (% patient) based on Electrocardiogram (ECG) readout as compared to control
Report of all adverse events including incidence, timing, severity, and relationship to the treatment
Time frame: 36 months
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).
Report of secondary surgical interventions
Time frame: 36 months
Any secondary surgical interventions required to treat the target defects (e.g., reoperations, supplemental fixation, or other interventions) will be recorded.
5 secondary outcomes
Patient reported outcome KOOS scores
Time frame: 5 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Patient reported outcome IKDC scores
Time frame: 5 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
MRI AMADEUS score
Time frame: Screening, 12 months
MRI MOCART score
Time frame: 12 months
Descriptive report of graft integration based on clinical evaluation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarindr Bhumiratana, PhD study director
Epibone, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EB-OC Graft Implantation and Abrasion chondroplasty in people with Chondral Defect and Osteochondral Defect, run by Epibone, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer N Jennings (12027423861, jjennings@mcra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse event incidents as compared to control (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.