Regeneus (ASX: RGS), a clinical-stage regenerative medicine company, today announced that the
previously reported positive results from its Phase 1 safety trial of Progenza in patients with knee
osteoarthritis (OA) have been published in the Journal of Translational Medicine1.
The STEP trial (Safety, Tolerability and Efficacy of Progenza) is the first clinical trial of Progenza, the
company’s allogeneic stem cell technology platform for the treatment of OA and other inflammatory
conditions. The publication of the results in a well-respected journal further validates the trial results.
In this study, a single injection into the knee of Progenza (3.9 million cells or 6.7 million cells) in patients was safe and well tolerated. Progenza also showed durable and clinically meaningful pain relief in patients
with knee OA. Examination of knee joint structure by MRI showed a statistically significant improvement in lateral tibial cartilage volume for patients treated with 3.9 million cells of Progenza compared to a
worsening in placebo patients (p=0.028).