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$PMCB Bio-Artificial Pancreas for Diabetes

"We plan to develop a therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes. Our therapy involves encapsulation of human cells that have been genetically engineered to produce, store insulin and release insulin on demand at levels in proportion to the levels of blood sugar (glucose) in the human body. We also plan to explore the encapsulation of human stem cells and beta islet cells as an alternative to using genetically modified human liver cells. The encapsulation will be done using the Cell-in-a-Box® technology.

Insulin-producing cells (HIT-T15) have already been encapsulated using the sodium cellulose sulfate-based technology found in Cell-in-a-Box®. Encapsulation did not affect cell viability or insulin production. In cell culture, the encapsulated cells were able to detect the glucose concentration in a nutrient solution and react in a proper way by producing insulin. In the opinion of the authors of the study, encapsulation of insulin-producing cells with sodium cellulose sulfate, which is more biocompatible and less immunogenic than other encapsulation materials, seemed to be a promising method for the immunoisolation of porcine beta islet cells for xenotransplantation to replace the endocrine pancreas. Schaffellner S., et al.
Transplantation Proc., Vol. 37, 248-252 (2005)

In an effort to avoid the use of non-human islet cells in its diabetes treatment, PharmaCyte has obtained from the University of Technology Sydney (“UTS”) in Australia an exclusive, worldwide license to use insulin-producing genetically engineered human liver cells developed by UTS to treat Type 1 diabetes and insulin-dependent Type 2 diabetes. These cells, named “Melligen,” have already been tested in mice and shown to produce insulin in direct proportion to the amount of glucose in their surroundings. In fact, when Melligen cells were transplanted into immosuppressed diabetic mice, their blood glucose levels became normal. The Melligen cells reversed the diabetic condition.

Melligen cells can be readily grown in culture and are available in unlimited supply. Compared to native pancreatic beta islet cells, Melligen cells are much more resistant to the pro-inflammatory cytokines that have been shown to be involved in beta islet cell death. We believe that this property makes them an ideal potential candidate cell line for beta islet cell replacement therapy with the prospect to achieve long-term transplant graft function. However, further research and development (“R&D”) needs to be done with the Melligen cells to insure they function as reported in the literature by UTS.

PharmaCyte has acquired from Austrianova an exclusive, worldwide license to use the Cell-in-a-Box® technology for the development of a treatment for diabetes. We believe that encapsulating the Melligen cells using Cell-in-a-Box® live cell encapsulation technology has numerous advantages over encapsulation of cells with other materials, such as alginate. Since our capsules are composed largely of cellulose (a bio-inert material in the human body), the Cell-in-a-Box® capsules are durable, resilient and long-lasting when compared to the competition. They remain intact for long periods of time in the body, all the while protecting the cells inside them from immune system attack. Also, in prior studies these capsules and the cells inside them have not caused any immune or inflammatory responses like those seen with alginate-encapsulated cells. Studies have shown that the Cell-in-a-Box encapsulation process does not reduce the capability of the Melligen cells to produce insulin."

https://pharmacyte.com/live-cell-encapsulation/diabetes/