New Study Launched to Test Stem Cells for Knee Pain

Progenza, a stem cell product made by Regeneus LTD, will be the subject of a clinical trial designed to determine the safety, tolerability and preliminary efficacy of intra-articular Progenza in adults with symptomatic knee osteoarthritis.

An independent Human Research Ethics Committee registered with the Australian Government’s National Health and Medical Research Council approved of the trial. It will also be registered on the Australian New Zealand Clinical Trials Registry and notified to the Therapeutic Goods Administration through the Clinical Trials Notification Scheme.

Progenza is produced from adipose tissue from a healthy donor who has been extensively screened. Company officials claim that adipose tissue is readily available from donors in large quantities and has significantly higher mesenchymal stem cells (MSCs) per gram of tissue than other tissue sources such as bone marrow or cord tissue.

The MSCs from adipose tissue are expanded through the company’s scalable manufacturing process that, they report, is capable of producing millions of therapeutic doses from one donor.

Company officials claim that when Progenza stem cells are injected into a patient’s osteoarthritic joint, the MSCs have the potential to reduce pain and inflammation and slow the progression of disease.

The trial will include 20 participants with knee osteoarthritis. Each will receive ultrasound-guided injections of Progenza or placebo directly into their arthritic knee joint. Participants will be monitored for 12 months.

Donald Kuah, M.D., the principal investigator on the trial, said, “I’m excited to be the principal investigator of the 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.”