Osteoarthritis

OA stem cells trial gets ethics approval


The Sydney based regenerative medicine company Regeneus has received ethics approval for its clinical trial of stem cells in patients with knee osteoarthritis.

Marketed as Progenza the stem cells are produced from the adipose tissue of a healthy donor. According to a company press release the “off-the-shelf allogeneic stem cell treatment” has the potential to reduce pain and inflammation and slow the progression of disease.

The STEP trial will include 20 participants with knee osteoarthritis who will receive ultrasound-guided injections of Progenza or placebo directly into their 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 1 month post treatment.

Sydney-based sports medicine specialist, Dr Donald Kuah, will be the principal investigator on the STEP Trial. Dr Kuah, a principal of Sydney Sportsmed Specialists, has extensive experience in the diagnosis and treatment of patients with osteoarthritis, the press release states.

“I’m excited to be the principal investigator of the STEP Trial evaluating the safety and preliminary efficacy of Progenza for osteoarthritis. 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”, said Dr Kuah.

Trial recruitment will commence as scheduled in the first-half of 2015.

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