Researchers from Midwest Orthopaedics at Rush in Chicago, the University of Kentucky Research Foundation in Lexington, and Beacon Orthopaedics & Sports Medicine in Cincinnati, Ohio, found evidence that a living cell cartilage repair allograft, processed by Centennial, Colorado-based AlloSource, can be “an effective long-term solution for osteochondral defect repair” at the 3-year follow up mark.
The living chondrocyte allograft is brand named ProChondrix CR and was tested as a treatment for focal articular cartilage defects in the knee. The living chondrocyte allograft was processed by AlloSource, a nonprofit organization, using “a living intact hyaline cartilage product that contains functional chrondrocytes and other biological components necessary for repair and replacement of damaged articular cartilage tissue.”
The clinical study was designed to evaluate this new allograft in approximately 80 patients who were scheduled to undergo treatment of a cartilage defect on the femoral condyle or patella. The research teams plan to follow treated patients for a minimum of 60 months after surgery. During this follow-up period, each patient is evaluated seven (7) times at: 3, 6, 12, 24, 36, 48 and 60 months postop.
Inclusion criteria was:
- Patient is ≥18 and ≤ 60 years old;
- 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;
- Radiographically diagnosed, by MRI, or through arthroscopy, to have a cartilage defect on the femoral condyle or patella between ≥ 1 cm2 and ≤ 5 cm2, measured as a rectangle length x width;
- Treatment is marrow stimulation plus ProChondrix CR procedure;
- Has an intact meniscus (maximum of ≤50% resected);
Exclusion criteria, of which there were 20 elements, is available at clinicaltrials.gov. (https://clinicaltrials.gov/ct2/show/NCT03873545)
So far, the research teams have provided preliminary data on 31 treated patients who had full thickness cartilage lesions of the knee (Grades II-III). The teams have gathered pre and postoperative International Knee Documentation Committee (IKDC) scores (assessing overall patient function) and Knee Injury and Osteoarthritis Outcome Score (KOOS) scores (assessing pain, functions in daily living and sports and quality of life). Average follow-up so far is at 15.1-months (3-36 months).
AlloSource’s Senior Director of Product Development, Innovation and Clinical Affairs Carolyn Rorick said to OTW, “We saw statistically significant improvement across all patient-reported outcome scores, most notably at 36 months where IKDC scores improved by 86.3% and KOOS improved by 132.5% from preoperative scores.”
“Based on the clinical outcomes of the patients at the three-year time point, we are extremely encouraged with the performance of ProChondrix CR as an effective long-term solution for osteochondral defect repair.”
“The study is ongoing, so we will continue to gather additional data to confirm the longer-term results.”
The key underlying technology was AlloSource’s proprietary cartilage cryopreservation process—ViaTrue—which resulted in an average of 94.97% chondrocyte viability after two years of cryopreserved storage, which, says the company, can help solve inventory management challenges and offers surgeons with more flexibility for their patients.
“We performed extensive testing to show the process not only maintains the viability of the chondrocytes, but also does not impact the native growth factors and extracellular matrix,” said Rorick.
For more information: https://allosource.org/products/prochondrix-cr/
