Regeneus (ASX: RGS), a clinical-stage regenerative medicine company, today announced that the first patient has been enrolled and treated in the STEP (Safety, Tolerability and Efficacy of Progenza) trial, the first clinical trial of Progenza, the company’s allogeneic stem cell product for the treatment of knee osteoarthritis.
A review of the sentinel patient’s safety data by the study safety oversight committee identified no safety concerns. Enrolment is now open to the remainder of the first cohort of 10 patients. A second and final cohort of 10 patients will receive a higher dose of cells.
The dosing of the first patient in the STEP trial achieves another milestone in the clinical development of the company’s allogeneic stem cell therapy.
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 partner of Sydney Sportsmed Specialists, has extensive experience in the diagnosis and treatment of patients with osteoarthritis.
The trial will include 20 participants with knee osteoarthritis treated at two different doses of cells. Participants will receive ultrasound-guided injections of Progenza or placebo directly into their arthritic knee joint. One in five patients will 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.