Clinical data regarding a novel cartilage implant developed in Finland was presented at the 9th Joint Preservation Congress in Warsaw, Poland, June 14-15, 2024.
The data represented interim results from a first-in-human pilot clinical trial according to the Finnish manufacturer, Askel Healthcare Ltd. The implant, which is a biodegradable polymer scaffold, is designed to treat symptomatic full-thickness chondral and osteochondral lesions in the knee joint.
Twenty patients are being enrolled in the pilot study. Each patient is asked to make seven visits to the investigational site, participate in a pre-operative baseline screening protocol and then if accepted into the study, be treated with the novel scaffold and bone marrow stimulation. Finally, the study team will be collecting follow-up data from each patient 3 months, 12 months and 24 months.
The implant’s brand name is COPLA®.
According to the study’s principal investigator, the interim results were very promising.
“As this was the first-in-human trial, there were somewhat conservative expectations on the results. It was great to see and hear how well and how quickly the patients’ well-being was improving after the surgery,” said Teemu Paatela, M.D., chief orthopedic surgeon and director of Musculoskeletal Businesses at Terveystalo, Finland’s largest private hospital chain and the coordinating principal investigator of the pilot trial.
“Clinically significant results were achieved already at 6-week (pain, Visual Analog Scale /Numeric Pain Rating Scale) and 3-month (Knee Injury and Osteoarthritis Outcome Score total and sub scores) follow-up timepoints and the improvement continued at 6-months.”
“I am very impressed with the initial results of COPLA,” commented Kondrad Slynarski, M.D., Ph.D., the coordinating principal investigator of the pivotal trial. “I was very excited to start the pivotal trial and see how my active patients in Poland will benefit from the treatment. I have high hopes for COPLA to deliver similar or even better results as in the pilot trial also within a bigger patient population in the pivotal trial.”
“Cartilage defects are prevalent, particularly among athletes, and existing treatments are often unreliable. The initial results with COPLA are impressive, showing promise for active patients by enabling early weight-bearing, swift rehabilitation, and a quick return to activities. However, it is important to note that these outcomes are based on a very small patient sample,” Dr. Paatela is also a member of Askel’s Clinical Advisory Board.
According to the company, tailoring and placing the implant to the lesion added on average 15 minutes to the length of surgery. No special instrumentation was needed. The first 10 subjects reported significant improvements in knee function and pain levels at the 6-month follow-up point.
In addition, the company reported, the first group of patients required no pain medication at 6 weeks post-surgery. The researchers also found that patients had improved knee movement and strength returning to pre-surgery levels within 3 months.
All patients returned to their pre-injury activity levels between 6 weeks and 3 months, which was maintained at 6 months. Patients reported high satisfaction with the surgery, noting an overall improvement in their quality of life.
When OTW asked how they are preparing for the next trial, Petra Raatikka, Askel’s Chief Clinical Officer noted, “The Pivotal Trial will aim to demonstrate the clinical benefits of COPLA in a randomized trial that is designed to show superiority over current surgical standard treatments and will serve as a cornerstone for market authorizations in the U.S. and EU.”
“The Askel team is engaging best-in-class vendors with breadth of domain expertise and experience in supporting innovative medical technologies to navigate the clinical trial process. The selected team has successfully worked on numerous medical technologies as an extension to the manufacturer’s team to navigate the approval process.”
“In addition, all pilot trial data that is coming in is reviewed and pivotal trial planning is adjusted if needed. Askel’s strategy involves collaboration with globally renowned orthopedic surgeons and sports medicine specialists in its clinical development. The company has established a prestigious Clinical Advisory Board comprising internationally recognized experts in cartilage damage treatment and they are closely involved with the pivotal trial planning.”
According to the company, the scientific article will be published once all 20 patients complete the 24-month follow-up period.
It would be helpful if the article provided the inclusion criteria for the study.