Regeneus completes stem cell manufacture for upcoming trial

Regeneus (ASX:RGS) has completed the manufacture of its off-the-shelf allogeneic stem cell therapy product, Progenza, for a human trial for the treatment of osteoarthritis (OA). This marks the first time Progenza has been produced at scale for use in a human trial.

Progenza is produced from adipose tissue from a healthy donor, whereby the mesenchymal stem cells (MSCs) from the tissue are expanded through the company’s manufacturing process. When Progenza cells are injected into the damaged joint or tissue, the MSCs have the ability to halt the progression of disease through the production of therapeutic factors in response to the signals of inflammation and tissue damage.

In March, the company announced preclinical study results which indicated the stem cells were found to be safe and to prevent disease progression for OA in an animal model. Regeneus Clinical Research Director Janet Wilson said, “The results showed no Progenza-related safety or toxicity issues … [and] Progenza-treated knees showed no deterioration from the time of injection, in contrast to the vehicle control group, which continued to deteriorate over the seven-week study.”

In preparation for the new trial, the company has expanded the donor adipose stem cells to a scale that demonstrates the capacity to produce, from a single donor, millions of therapeutic doses of Progenza (based on 5-10 million cells per dose). Regeneus CEO John Martin explained that the production of commercial quantities of stem cells from a single donor will maximise dose-to-dose consistency, minimise clinical trial and regulatory risks, and reduce the cost of the final product.

“One of the key advantages for manufacturing Progenza at industrial scale is that it uses stem cells sourced from adipose or fat tissue,” Martin continued. “Adipose tissue is readily available from donors in large quantities and has significantly higher stem cells per gram of tissue than other tissue sources such as bone marrow or cord tissue. Adipose-derived stem cells also show greater capacity for expansion than stem cells from other tissue types.”

Regeneus is on track to receive ethics approval and commence recruitment for the human trial in the first half of 2015. The company’s shares were trading 7.407% higher at $0.145 as of around 3 pm on Wednesday