Regeneus (ASX:RGS), a clinical-stage regenerative medicine company, today announced completion of a review of safety from the first cohort of 10 patients in the STEP trial. A review of the safety data from Cohort 1 by the study safety oversight committee identified no safety concerns. Enrolment is now open to the second and final cohort of 10 patients.
The STEP trial (Safety, Tolerability and Efficacy of Progenza) is the first clinical trial of Progenza, the company’s allogeneic off-the-shelf stem cell product for the treatment of knee osteoarthritis.
The completion of Cohort 1 and opening of enrolment to Cohort 2 demonstrates good progress towards the clinical development of the company’s allogeneic stem cell therapy. It is anticipated that Cohort 2 will be recruited in H1 2016.
The trial is entitled, "A Phase 1 randomised, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability and preliminary efficacy of intra-articular Progenza in adults with symptomatic knee osteoarthritis".
Leading Sydney-based sports medicine specialist, Dr Donald Kuah, is the Principal Investigator on the trial. Dr Kuah, a principal of Sydney Sportsmed Specialists, has extensive experience in the diagnosis and treatment of patients with osteoarthritis.
The trial includes 20 participants with knee osteoarthritis treated at two different doses of cells. Participants receive ultrasound-guided injections of Progenza or placebo directly into their arthritic knee joint. One in five patients receive a placebo injection. The primary objective of the trial is to evaluate the safety and tolerability of Progenza. The secondary objectives are to investigate the effect of Progenza on knee pain and function; quality of life; knee joint structures using magnetic resonance imaging; and osteoarthritis biomarkers. Participants will be monitored for 12 months.