RESEACH COLLABORATION. A newly established European research collaboration aims to investigate whether engineered cartilage can be used to treat a common form of osteoarthritis that causes pain in the front part of the knee joint. The EU is investing a total of 11 million euros in the project. Researchers at the University of Gothenburg are contributing, among other things, by enrolling patients and analyzing the results.

The study is testing a treatment for patellofemoral osteoarthritis, which causes swelling and pain in the front of the knee joint. The condition is very common. Approximately twenty percent of people over fifty years of age are estimated to experience knee pain due to this form of knee osteoarthritis. The condition develops over a long period, gradually changing the cartilage between the kneecap and the thigh bone. Over time, the joint surfaces are affected, causing bone-on-bone friction.

Clinical trial

The EU project is called ENCANTO. It is a multicenter study for a double-blind, randomized clinical trial at eleven clinical centers in six EU countries and Switzerland. This phase 2 study is based on previous studies conducted by several parties within the consortium, which have led to the development of the medical product N-TEC.

“The product N-TEC consists of engineered cartilage from the septum between the nostrils, combined with a collagen membrane to create a graft that can be shaped and used to cover the cartilage defect in the affected knee. N-TEC is shaped by the operating surgeon and securely attached to then heal and integrate with surrounding tissue,” explains Professor Kristian Samuelsson, who leads the University of Gothenburg’s participation in the large project.

Tested on two groups

The new treatment has been tested in previous studies for patients with traumatic knee osteoarthritis, where patients have experienced reduced pain and improved mobility, leading to increased activity levels for the individual patient.

“In this project, the treatment will now be tested for two groups of patients with patellofemoral osteoarthritis, who have milder or more severe forms of osteoarthritis. The study has two arms where treatment with N-TEC is compared with two other treatments in each arm,” says doctoral student Alexandra Horvath, who also works within the EU project.

In one arm of the study, N-TEC is compared with another type of collagen matrix (AMIC). In the other arm, N-TEC is compared with patellofemoral prosthesis. The treatment will be evaluated based on patient-reported outcomes, imaging techniques, biomarkers linked to clinical outcomes, and health economic costs.

The research team in Gothenburg will receive just over SEK three million of the project’s total budget. They will use this funding not only to design the study but also to help enroll patients. The Gothia Forum has been a significant support for the researchers in planning the project, with project leader Louise de Verdier particularly involved.

BY: ELIN LINDSTRÖM

 

The consortium consists of the following parties:

CLINICAL CENTERS:

• Fondazione Policlinico Universitario Campus Bio-Medico (FPUCBM), Rome, Italy (coordinator)
• University of Milan and Ospedalde Galeazzi Spa, Milan, Italy
• University Hospital Basel/University Hospital Basel, Switzerland (UNIBAS/USB, manufacturer of N-TEC)
• University Hospital Sveti Duh, Zagreb, Croatia
• Julius-Maximilians-Universität Würzburg, Würzburg, Germany
• University Hospital Würzburg, Würzburg, Germany (UKW, manufacturer of N-TEC)
• Evangelisches Waldkrankenhaus Spandau, Berlin, Germany
• Medizinische Universitaet Wien, Vienna, Austria
• Orthopedic Hospital Vienna-Speising, Vienna, Austria
• Zeromski hospital Krakow, Krakow, Poland
• University of Gothenburg/Sahlgrenska University Hospital, Gothenburg, Sweden

OTHER PARTIES:

• CrossKlinik Basel, Basel, Switzerland
• Maastricht University, Maastricht, Netherlands
• University of Oulu, Oulu, Finland
• PROMOVE-BIOTEC GmbH, Germany
• Videoreha ltd., Croatia
• TheraCell Advanced Biotechnology, Greece