Overview

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.

Project Facts

Contract/Grant agreement number:

643809

EC contribution:

5,999,000

Duration:

48 months

Starting date:

January 2015