Trials

STEP Trial: Allogeneic stem cell therapy for the treatment of knee osteoarthritis

The company completed a Phase I safety trial of Progenza in patients with knee osteoarthritis, meeting the primary endpoint of safety and tolerability. The study shows that a single injection into the knee of either dose of Progenza in patients appeared safe and well tolerated. Progenza also showed durable and clinically meaningful pain relief.

ACTIVATE Trial: Autologous cancer vaccine for patients with advanced cancers

The single centre Phase 1 clinical trial, known as the ACTIVATE trial, is an open label, first in-human, dose escalating study to evaluate the safety, tolerability and preliminary efficacy of RGSH4K, administered in 21 patients with advanced cancers. To facilitate the trial, Regeneus has established an ethics-approved tumour bank. Participants in the trial will need to have stored a tumour sample, which then may be used to produce an autologous cancer vaccine for individual patient’s use in the trial. Further detail in relation to the trial and the tumour bank can be found on the The Australian New Zealand Clinical Trials Registry website. Both the tumour bank and the vaccine trial are actively recruiting.

Pre-pivotal canine OA trial for CryoShot

The pre-pivotal placebo-controlled trial assessing CryoShot as a treatment for canine osteoarthritis of 80 dogs is underway at the University of Pennsylvania School of Veterinary Medicine. All trial participants are followed for 90 days.

Kvax Lymphoma trial with SASH

The 45-dog trial of Kvax in combination with standard of care chemotherapy for the treatment of canine lymphoma, is underway at Small Animal Specialist Hospital (SASH) in Sydney. The trial is actively recruiting.

Cell identification and selection technology for chronic pain

Regeneus, in collaboration with Macquarie University and University of Adelaide have been awarded a $340,000 Linkage Grant by the Australian Research Council for a 3 year research project which will seek to develop a better understanding of chronic pain and how it affects women and men differently and how stem cells specially selected for their cytokine profiles can be used to relieve chronic pain in animals and help lay the foundations for future human therapies.