As well as providing new surgical options to patients, the creation of the Cartilage Repair Centre shall also increase Irish participation in international studies evaluating the role of stem cells, scaffolds and other biological options. Providing leadership across both clinical and laboratory sites can ensure that the highest international levels of care are available to all patients in Ireland. The long term aim of this unit is to lead Ireland’s recognition as a key translational site for Regenerative Medicine and Tissue Engineering as applied to Orthopaedics and Sports Medicine.
Osteoarthritis (OA) is an incurable and debilitating disease. It has been identified as the world’s eleventh highest contributor to disability and affects over 70 million Europeans. There is currently no treatment to prevent progression of the disease.
In the absence of effective pharmacological, biological or surgical treatment options, cellular therapies using mesenchymal stem/stromal cells (MSCs) have emerged as potential treatments for this condition. Autologous adipose-derived mesenchymal stromal cells (ASCs) are an attractive option for these cellular therapies because of the abundance of tissue, high frequency of MSCs, and minimally invasive harvest procedure.
The EU consortium ADIPOA has shown in a ‘first in man’ 2-centre Phase I safety study that intraarticular injection of a single dose of autologous ASCs to the knee (18 patients, 12 month follow-up) was well-tolerated, had no adverse effects, and resulted in an improvement in pain score and functional outcome. ADIPOA-2 will build on the work of ADIPOA to deliver a large-scale clinical trial in regenerative medicine for OA. The purpose of the project is to design and implement a phase IIb study to assess the safety and efficacy of autologous (patient-derived) ACSs in the treatment of advanced OA of the knee. The cells will be prepared from samples of adipose tissue harvested from patients by lipoaspiration.
ADIPOA-2 will carry out a multi-centre, randomized clinical trial comparing the use of culture-expanded, autologous adult ASCs in subjects with knee OA with injected Hyaluronan (another widely used therapeutic approach for knee degeneration). This study will involve two major elements: the production of consistent batches of high-quality autologous ASCs under GMP-compliant conditions and the delivery of these cell doses to patients in a trial which will meet all national and European regulatory and ethical standards and which will provide a definitive demonstration of the safety and efficacy of ASCs as a therapy for osteoarthritis.
Cartilage Regeneration Scaffolds
Clinical Trials are also being developed for the evaluation of novel scaffolds and orthobiologics in patients with symptomatic cartilage injury. This work builds on prior laboratory research at RCSI and Surgacoll and will link laboratory research to clinical care at Sports Surgery Clinic and Cappagh National Orthopaedic Hospital.
ChondroColl™ is a biomimetic, bioactive layered scaffold for use in the regeneration and repair of osteochondral defects (cartilage repair), such as those which occur due to trauma or osteoarthritis. ChondroColl™ closely matches the structure and composition of osteochondral tissue.
The scaffold is a highly porous collagen-based construct comprised of a number of distinct but seamlessly integrated layers, designed to closely mimic physiological osteochondral tissue in terms of both composition and structure. Each of the individual layers has a composition tailored to mimic the native tissue with a gradient pore/fibre structure modelled on the superficial to deep zones of articular cartilage and underlying subchondral bone.
This resorbable cartilage graft substitute, with proven in vitro and pre-clinical performance, offers an exciting early intervention option to orthopaedic surgeons in the treatment of damaged articular cartilage and may offer the potential to delay the need for full joint replacement.