Regeneus (ASX:RGS) announced that it has received ethics approval for a clinical trial of its new off-the-shelf allogeneic stem cell treatment PROGENZA for human knee osteoarthritis.
PROGENZA is produced from mesenchymal stem cells derived from the adipose (fat) tissue of a healthy donor who has been extensively screened.
The company said that its proprietary and scalable manufacturing process is capable of producing millions of therapeutic doses from one donor.
The Phase 1 trial is a randomised, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability and preliminary efficacy of PROGENZA in adults with symptomatic knee osteoarthritis.
It follows the company announcing in March that it had successfully completed a pre-clinical study of PROGENZA at a US-based facility. The results showed no PROGENZA-related safety or toxicity issues, even at doses well in excess of the intended human dose.
Sydney-based sports medicine specialist Dr Donald Kuah will be the principal investigator on the STEP Trial.
"I'm excited to be the principal investigator of the STEP Trial evaluating the safety and preliminary efficacy of PROGENZA for osteoarthritis," he said.
"The clinical testing of an off-the-shelf allogeneic cell therapy like PROGENZA which could address the underlying cause of the disease is important for providing a new potential treatment option to patients with osteoarthritis."
The STEP Trial will include 20 participants with knee osteoarthritis.
Participants will receive 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; knee joint structures using magnetic resonance imaging; and osteoarthritis biomarkers.
Participants will be monitored for 12 months with an interim safety review at one month post treatment.
Trial recruitment will commence as scheduled in the first-half of 2015.