Using cryopreserved cartilage grafts to treat knee cartilage damage

A Prospective, Open Label, Single-Arm, Multi-Center Study Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee

This study is testing if using frozen cartilage grafts can help people aged 12 to 60 with knee cartilage damage feel better and heal over time.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 12 Years to 60 Years
• Sex: All
• Sponsor: AlloSource (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 6 sites (Phoenix, Arizona and 5 other locations)
• Trial ID: NCT06216756 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of cryopreserved osteochondral allograft cores in treating osteochondral lesions on the femoral condyle of the knee. Eligible patients, aged 12 to 60, with symptomatic full-thickness cartilage lesions will receive one or more transplants of these grafts during an osteochondral transplant procedure. Participants will be monitored for up to 60 months to assess both short-term and long-term outcomes of the treatment. The study aims to provide evidence on the efficacy of this innovative approach to cartilage repair.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12 to 60 with symptomatic, full-thickness cartilage lesions on the femoral condyle that have not responded to conservative treatments.

Not a fit: Patients with stable knee conditions that do not require transplantation or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve knee function and reduce pain for patients with severe cartilage damage.

How similar studies have performed: Other studies have shown promise in using osteochondral allografts for cartilage repair, suggesting a potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Phoenix, Arizona and 5 other locations

• Banner- University Medical Center- Phoenix Orthopedic and Sports Medicine Institute — Phoenix, Arizona, United States (Recruiting)
• Cedars-Sinai Kerlan Jobe Institute — Los Angeles, California, United States (Not_yet_recruiting)
• Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City — Redwood City, California, United States (Recruiting)
• University of California San Francisco — San Francisco, California, United States (Recruiting)
• Rush Copley Medical Center — Aurora, Illinois, United States (Recruiting)
• University of Kentucky Research Foundation — Lexington, Kentucky, United States (Recruiting)

Study contacts

• Study coordinator: Elizabeth Esterl, DNP, MS, RN

Conditions Osteochondral Defect