Exogenous subcutaneous insulin delivery is imprecise, and even optimized subcutaneous pumps and sensors fail to provide physiologic insulin delivery with sufficiently dynamic insulin release or shut-off. For this reason the use of biological cell-based approaches, such as Elastislet, are preferred for sustained precision normoglycaemia.
Clinical pancreatic islet transplantation is one of the safest and least invasive transplant procedures that holds great promise for the treatment of DM. Currently, this therapy has two important drawbacks that Elastislet has successfully overcome.
The first one is that the availability of pancreas from deceased donors is quite limited and can restrict the applicability of the islets transplantation procedure. Elastislet has set up a protocol for the differentiation of hiPSC that leads to pancreatic endocrine cell phenotypes that permit to obtain unlimited and cost-effective sources of insulin-producing cells and other endocrine cell clusters.
The second one is the necessity for immuno-suppressive drugs post-transplant, which may lead to important complications such as infection, cancer and organ system toxicity. It has been demonstrated that ELRs, being fully immunologically inert and biocompatible, can effectively coat the cells and prevent immune rejection in different in vivo models. The proof of concept for immunoprotection of allogeneic islets and hiPSCs in experimental transplantation has been stablished.
Since the encapsulated islets and hiPSCs have demonstrated to be absolutely ignored by the immune system, the persistence and functionality of the implant are quite longer than in current transplantation strategies in which the cells are not coated or the capsule is not fully immune-protective.
According to the literature, the current clinic results of non-coated islets transplantation give evidence of a prevalence of insulin independence of approximately one year in immune-suppressive patients. It is expected that Elastislet prevalence will be higher without the need for immune-suppressants, thanks to the effective immune-protection effect of the capsule, which will have a high impact in patient’s quality of life.
The elimination of immunosuppressant drugs in transplanted patients not only reduces the prevalence of associated complications but also the need for recurrent transplants. All of this results in an important reduction of the post-transplant medical costs with regard to the current transplantation strategies, which is estimated to be around the 43% of the total costs associated to DM.
Therefore, Elastislet has taken an important step toward the definitive cure of DM
