Trials

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

The STEP trial is a randomised, double-blind, placebo-controlled single ascending dose clinical trial in which the safety, tolerability and preliminary efficacy of intra-articular Progenza will be evaluated in adults with symptomatic knee OA (the STEP Trial). 20 participants received ultrasound-guided injections of Progenza or placebo directly into their arthritic knee joint. 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 and knee joint structures using magnetic resonance imaging and osteoarthritis biomarkers. Recruitment was completed in May 2015 and participants will be monitored for up to 12 months. Further detail in relation to the trial can be found on the The Australian New Zealand Clinical Trials Registry website.

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. The trial is actively recruiting and is scheduled for completion by the end of FY17.

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.