Osteoarthritis (OA), an incurable and incapacitating disease has been identified as the world’s eleventh highest contributor to disability affecting over 70 million Europeans and the single most common cause of disability in older adults. There is currently no pharmaceutical treatment to prevent or reverse progression of this disease.
The need for alternative options has therefore increased in default of effective pharmacological, biological or surgical treatment options. Cellular therapies using mesenchymal stem/stromal cells (MSCs) has become an enticing potential treatment alternative for this condition; use of autologous adipose tissue-derived stromal cells (ASCs) for the cellular therapy is an attractive option thanks to the tissue abundance; it being the richest source of MSCs, minimally invasive and possible repeated harvesting.
The purpose of the first in man 2-centre Phase I clinical trial carried out by the ADIPOA consortium in France and Germany was to assess the safety and efficacy of single intra-articular low dose injection of AD MSCs. The study was carried out on 18 patients with severe osteoarthritis requiring athroplasty and followed up for 12 months. The result after clinical outcomes and MRI findings evaluation showed it was well-tolerated, had no adverse effects, and resulted in an improvement in pain score and functional outcome. However, randomized controlled trial is warranted before conclusion on efficacy can be taken.
ADIPOA-2 will develop on the work of ADIPOA to deliver a large-scale clinical trial in regenerative medicine for OA. The purpose is to design and implement the phase IIb study scheduled to assess the safety and efficacy of autologous (patient-derived) ACSs in the treatment of advanced OA of the knee thus confirm the clinical benefit of this strategy. The cells will be prepared from samples of adipose tissue harvested from patients by lipoaspiration under anesthesia.
The ADIPOA-2 will execute a multi-centre, randomized clinical trial comparing the use of culture-expanded, autologous adult ASCs in subjects with osteoarthritic knee with injected Hyaluronan (another widely used therapeutic approach for knee OA). 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 provide a definitive affirmation of the safety and efficacy of ASCs as a therapy for osteoarthritis. This first of its kind clinical trial will be a crucial milestone in the treatment of a condition which has evaded all previous therapeutic efforts other than joint replacement surgery.