Sunday, August 31, 2014 5:07:53 PM
http://www.hindawi.com/journals/amed/2014/429710/
Pay particular attention to the paragraphs:
"To increase the stability and to reduce the permeability of alginate gel beads, a polycation layer is traditionally added to the alginate gel core [67–70]. However, the successful use of alginate-polycation capsules as carriers for insulin producing cells in vivo has been hampered by the capsule’s lack of biocompatibility as well as their mechanical instability. These disadvantages have made controlled insulin release and immunoprotection of islets difficult to achieve. The major obstacle for stability is swelling, causing an increase in pore size and ultimately breakage. This is caused by the loss of calcium from the calcium-alginate gel by, for example, phosphate and citrate, which can bind calcium, and nongelling ions such as sodium that over time will exchange some of the calcium in the gel [71]."
"As mentioned before, in the ongoing clinical islet transplantation protocols, the donor pool cannot provide enough islets to treat all potential patients. Therefore, different cell sources have been investigated to overcome this problem, including xenogeneic pig islets [134–136], genetically engineered insulin-producing cells [137], and insulin-producing cells differentiated from stem cells [138–140]. Since these cell types are potential alternative cell sources for clinical islet transplantation, they are also being considered for clinical encapsulated islet transplantation. However, to date only encapsulated porcine islets have been tested in patients with T1DM [43]. The encapsulation of other cell types has only been tested in experimental animal models to investigate the features of growth, differentiation, and maturation [37, 141, 142]."
"Taking all these obstacles into account, the development of a centralized in vitro and in vivo testing center in the future would allow for a more comprehensive, consistent, and species-specific examination of biocompatibility for the encapsulation system. A collaborative consortium may need to be organized, which should lead to the standardization in material selections, techniques, animal models, and procedures. Under active collaboration between research facilities, the end goal of providing islet encapsulation as a viable cure for patients with T1DM without immunosuppressant would be achievable."
Alginate-based cell encapsulation has numerous pitfalls which still need to be overcome and may never be. However, negotiations are underway between Nuvilex and a major Australian university for an exclusive, worldwide license to use their insulin-producing cells in combination with the Cell-in-a-Box ® technology in developing a product for the treatment of insulin-dependent diabetes, contingent upon a tumorigenicity test to be performed by Dr. Gunzburg at the University of Veterinary Medicine Vienna (“UVMV”) where Dr. Günzburg is a professor in the Department of Virology. Nuvilex is in the process of developing a diabetes consortium consisting of major universities, renowned scientists and physicians and CNS (“Diabetes Consortium”). Executive officers of Nuvilex and the institutions identified above have already explored the possibility of joining the Diabetes Consortium. These institutions will be part of the Diabetes Consortium, as will Dr. Gunzburg and Dr. Salmons through their consulting company, Vin-de-Bona Trading Co. Pte Ltd (“Vin-de-Bona”). The consensus among individuals that could be involved is that the formation of the Diabetes Consortium would be beneficial to all parties and may be a way of optimizing the development of Nuvilex’s treatment for diabetes given the free flow of ideas and communication that would occur within such a consortium. Dr. Löhr has a great deal of interest and expertise in treating diabetes. Because of this, he will be assisting Nuvilex in the development of a treatment for diabetes that will employ the Cell-in-a-Box ® cellulose-based live cell encapsulation technology.
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