Osteochondral DefectNCT06216756
Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
A study testing osteochondral transplant on the femoral condyle in people with Osteochondral Defect, run by AlloSource at 6 sites in United States.
Trial summary
The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Osteochondral Defect
- What is being tested?
- osteochondral transplant on the femoral condyle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Dec 2024to Mar 2031
- Phase
- Interventional
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients are ≥12 years and ≤ 60 years of age at the time of surgery.
- Symptomatic patient presenting with moderate to severe pain in the index knee - unresponsive to conservative treatment (i.e., medication, bracing, physical therapy) and/or previous surgical intervention OR unsalvageable lesion that requires transplantation at the discretion of the treating physician.
- Radiographically diagnosed, by MRI or CT scans, or through arthroscopy, to have a cartilage defect on the femoral condyle between 0.9-8.0 cm2 in size.
- Will be having an osteochondral transplant procedure.
- Has a mechanically stable knee or can be mechanically stabilized in the same procedure.
- Has a normally aligned knee as confirmed by anatomic comparison to contralateral limb, or <5° varus or valgus malalignment that has been corrected or will be corrected in same procedure.
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- Ipsilateral knee compartment has intact menisci or requires partial meniscectomy ≤ 50% resulting in stable menisci.
- Confirmation MRI, CT scan, or arthroscopy obtained pre-operatively within 90 days of surgery
- Willingness to follow standardized rehabilitation procedures.
- Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
Who cannot join
- Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface).
- Has had a prior osteochondral allograft transplant procedure in the same knee.
- Will be receiving a meniscus allograft transplantation in the same procedure.
- Body Mass Index (BMI)of ≥ 35 kg/m2.
- Active malignancy: undergoing treatment for tumor or boney traumatic injury or a history of any invasive malignancy (except non-melanoma skin cancer) unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
- Clinical and/or radiographic disease in the affected joint that includes generalized osteoarthritis, gout or a history of gout or pseudo-gout.
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- Active local microbial infection or a systemic infection, including HIV, syphilis, Hepatitis B or Hepatitis C.
- Currently immunologically suppressed or immunocompromised, or a medical condition requiring radiation and/or chemotherapy.
- Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer, or uncontrolled diabetes.
- Has a history of any inflammatory joint arthropathy.
- Currently using/chronic on oral corticosteroids.
- Received interarticular corticosteroid injection ≤ 90 days prior to surgery.
- Received hyaluronic acid injections into the joint space ≤ 45 days prior to surgery.
- Is a female patient who is pregnant.
- Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his/her ability to participate in the clinical study.
- Has a history of substance abuse- (including but not limited to recreational drugs, alcohol) or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an in-patient substance abuse program.
- Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol.
- Is currently involved in a study of another investigational product for similar purpose or has been in the previous 90 days.
- Has any contraindications for MRI.
- Is having the procedure as part of a Worker's Compensation claim.
- Is a ward of the state, prisoner, or transient.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Rush Copley Medical Center
Aurora, Illinois, 60504
Starlyn Nadeau, RN, 630-361-4267, starlyn_nadeau@rush.edu
Brian E Walczak, DO, PhD
- Recruiting
University of Kentucky Research Foundation
Lexington, Kentucky, 40506
Caitlin Conley, 859-257-1939, caitlin.conley2@uky.edu
Austin Stone, MD, PhD
- Not yet recruiting
Cedars-Sinai Kerlan Jobe Institute
Los Angeles, California, 90045
Karla Gonzalez, CRC, karla.gonzalez@csh.org
Michael Banffy, MD
- Recruiting
Banner- University Medical Center- Phoenix Orthopedic and Sports Medicine Institute
Phoenix, Arizona, 85006
Maria Jimenez, CRC II, 602-614-8549, Maria.Jimenez2@bannerhealth.com
Thomas Carter, MD
- Recruiting
Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City
Redwood City, California, 94063
Allen Seo, allenseo@stanford.edu
Seth Sherman, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Jocelyn Carpio, jocelyn.carpio@ucsf.edu
Drew Lansdown, MD
About this study
Official title: A Prospective, Open Label, Single-Arm, Multi-Center Study Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle.
Read the detailed description
Patients between the ages of ≥12 years and ≤ 60 years who have a symptomatic full-thickness cartilage lesion (Grade 3 or 4) on the femoral condyle, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between 0.9-8.0 cm2 in size, and cystic changes requiring osseous repair, as confirmed by MRI , CT scan, or arthroscopy, and undergoing an osteochondral transplant procedure will be eligible for enrollment. Patients will receive one or more cryopreserved osteochondral allograft core transplants to replace damaged cartilage.
Patients will be followed for up to 60 months post-procedure (6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months) to evaluate short and long-term outcomes of the procedure using the cryopreserved osteochondral allograft cores.
- Conditions
- Osteochondral Defect
- Being tested
- osteochondral transplant on the femoral condyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteochondral transplant on the femoral condyleProcedure or surgery
Patients between the ages of ≥12 years and ≤ 60 years who have a symptomatic full-thickness cartilage lesion (Grade 3 or 4) on the femoral condyle, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between 0.9-8.0 cm2 in size, and cystic changes requiring osseous repair, as confirmed by MRI , CT scan, or arthroscopy and will undergo a osteochondral transplant by removing the damaged cartilage and replacing that cartilage with a cryopreserved osteochondral allograft core.
| Study group | Role | What they receive |
|---|---|---|
| Osteochondral transplant on the femoral condyle | Experimental | Eligible and enrolled patients will receive one or more cryopreserved osteochondral allograft core as part of their osteochondral transplant procedure Receives: Procedure: osteochondral transplant on the femoral condyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC) score
Change of physical functioning and pain from baseline as assessed by the subjective International Knee Documentation Committee (IKDC) score.
Scores are reported on a 0-100 scale, with low scores indicating worse outcomes and higher scores indicating better outcomes.
Measured: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure
Secondary outcomes (5)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change from baseline (pre-operative)
Scores are reported on a 0-100 scale, with low scores indicating worse outcomes and higher scores indicating better outcomes.
Measured: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Assessment of repair cartilage structure
Assessment of repair cartilage structure, using Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores, as measured by Magnetic Resonance Imaging (MRI).
Scores are reported on a 0-100 scale, with low scores indicating worse outcomes and higher scores indicating better outcomes.
Measured: 12 months, 24 months and 60 months post procedure
Graft incorporation
Assessment of graft incorporation using Magnetic Resonance Imaging (MRI)
Measured: 12 months, 24 months and 60 months post procedure
12-item Veterans RAND (VR-12)
Change from baseline (pre-operative)
The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, a "Physical Health Summary Measure" and a "Mental Health Summary Measure."
Measured: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure
Revision surgery
Incidences of revision surgeries during study follow up time period
Measured: 60 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Dec 2024
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlloSource
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216756
- Sponsor's protocol ID
- COCA-OCA-001
- Status last verified
- Nov 2025
- First submitted
- 11 Jan 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After patients have signed the ICF and have been determined to meet the inclusion/exclusion criteria, the patient will be given a patient identification number that consists of a 2-digit site number and a 3-digit patient number. As allowed by governing privacy requirements, this will serve as a patient's identifier on all study-related documentation.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Single-Arm, Multi-Center Study Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
- ClinicalTrials.gov ID
- NCT06216756
- Acronym / sponsor ID
- COCA-OCA-001
- Conditions
- Osteochondral Defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- AlloSourceIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 22 Jan 2024 (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.
The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle.
Detailed description
Patients between the ages of ≥12 years and ≤ 60 years who have a symptomatic full-thickness cartilage lesion (Grade 3 or 4) on the femoral condyle, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between 0.9-8.0 cm2 in size, and cystic changes requiring osseous repair, as confirmed by MRI , CT scan, or arthroscopy, and undergoing an osteochondral transplant procedure will be eligible for enrollment. Patients will receive one or more cryopreserved osteochondral allograft core transplants to replace damaged cartilage.
Patients will be followed for up to 60 months post-procedure (6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months) to evaluate short and long-term outcomes of the procedure using the cryopreserved osteochondral allograft cores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteochondral transplant on the femoral condyle | Experimental | Procedure: osteochondral transplant on the femoral condyleEligible and enrolled patients will receive one or more cryopreserved osteochondral allograft core as part of their osteochondral transplant procedure |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Patients are ≥12 years and ≤ 60 years of age at the time of surgery.
- Symptomatic patient presenting with moderate to severe pain in the index knee - unresponsive to conservative treatment (i.e., medication, bracing, physical therapy) and/or previous surgical intervention OR unsalvageable lesion that requires transplantation at the discretion of the treating physician.
- Radiographically diagnosed, by MRI or CT scans, or through arthroscopy, to have a cartilage defect on the femoral condyle between 0.9-8.0 cm2 in size.
- Will be having an osteochondral transplant procedure.
- Has a mechanically stable knee or can be mechanically stabilized in the same procedure.
Key exclusion criteria (21 listed)
- Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface).
- Has had a prior osteochondral allograft transplant procedure in the same knee.
- Will be receiving a meniscus allograft transplantation in the same procedure.
- Body Mass Index (BMI)of ≥ 35 kg/m2.
- Active malignancy: undergoing treatment for tumor or boney traumatic injury or a history of any invasive malignancy (except non-melanoma skin cancer) unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
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 |
|---|---|---|
| osteochondral transplant on the femoral condylePatients between the ages of ≥12 years and ≤ 60 years who have a symptomatic full-thickness cartilage lesion (Grade 3 or 4) on the femoral condyle, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between 0.9-8.0 cm2 in size, and cystic changes requiring osseous repair, as confirmed by MRI , CT scan, or arthroscopy and will undergo a osteochondral transplant by removing the damaged cartilage and replacing that cartilage with a cryopreserved osteochondral allograft core. | Procedure or surgery | Osteochondral transplant on the femoral condyle |
Primary outcome
International Knee Documentation Committee (IKDC) score
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure
Change of physical functioning and pain from baseline as assessed by the subjective International Knee Documentation Committee (IKDC) score. Scores are reported on a 0-100 scale, with low scores indicating worse outcomes and higher scores indicating better outcomes.
5 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Assessment of repair cartilage structure
Time frame: 12 months, 24 months and 60 months post procedure
Graft incorporation
Time frame: 12 months, 24 months and 60 months post procedure
12-item Veterans RAND (VR-12)
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure
Revision surgery
Time frame: 60 months post-procedure
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 25 Nov 2025.
- Individual participant dataSharing planned: No. After patients have signed the ICF and have been determined to meet the inclusion/exclusion criteria, the patient will be given a patient identification number that consists of a 2-digit site number and a 3-digit patient number. As allowed by governing privacy requirements, this will serve as a patient's identifier on all study-related documentation.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteochondral transplant on the femoral condyle in people with Osteochondral Defect, run by AlloSource at 6 sites in United States.
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 10 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Elizabeth Esterl, DNP, MS, RN (7207326231, eesterl@allosource.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) score (time frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure). 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 25 Nov 2025.