Enrolment completed in stem cell trial for osteoarthritis


Monday, 16 May, 2016


Regenerative medicine company Regeneus (ASX:RGS) has completed the enrolment of all 20 patients in its STEP trial — the first clinical trial of the company’s allogeneic off-the-shelf mesenchymal stem cell (MSC) product for the treatment of knee osteoarthritis.

The primary objective of the STEP (Safety, Tolerability and Efficacy of Progenza) trial is to evaluate the safety and tolerability of the MSC product, Progenza, while the secondary objective is to investigate its effect on knee pain and function, quality of life, knee joint structures and osteoarthritis biomarkers. Participants will be monitored for 12 months.

The stem cells in Progenza are sourced from adipose tissue, which is readily available and can be sourced in large initial quantities. When Progenza cells are injected into a damaged joint or tissue, the MSCs have the potential to reduce pain and inflammation and slow the progression of osteoarthritis.

The trial began in August last year, when the first participant from the first cohort of 10 patients was treated by the product. Enrolment in the second cohort, who will receive a higher dose of cells than the first, has now been completed ahead of schedule.

A review of the cumulative study safety data by the study safety oversight committee identified no safety concerns. The review included a minimum of one-month safety data for all patients, and substantially more data for earlier-enrolled Cohort 1 patients.

The study will conclude once the last patient completes 12 months of post-treatment follow-up, concluding with a second MRI.

Regeneus (ASX:RGS) shares were trading 9.68% higher at $0.17 as of around 1 pm on Monday.

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