THE ADIPOA-2 CLINICAL TRIAL TO TREAT PEOPLE WITH MILD TO MODERATE OSTEOARTHRITIS OF THE KNEE, ACTIVE AND UNRESPONSIVE TO CONSERVATIVE THERAPY FOR AT LEAST 12 MONTHS IS NOW RECRUITING ACROSS ITS CLINICAL TRIAL SITES. FOR MORE INFORMATION ABOUT THE ADIPOA-2 CLINICAL TRIAL, PLEASE CLICK here.
ADIPOA-2 will carry out a multi-centre, randomized clinical trial comparing the use of culture-expanded, autologous adult adipose-derived stromal cells (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.
The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo) when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years.
This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.