Regenerative Medicine
Kadimastem lead project in Regenerative Medicine for the cure of Diabetes
Type I Diabetes, or Juvenile Diabetes, is caused by the destruction of the pancreatic islets of Langerhans that contain the cells producing insulin and other hormones (such as glucagon) which are necessary for maintaining the normal steady level of glucose. Type II diabetes in older patients is also associated with dysfunction of the pancreatic islet cells. In the absence of functional islets, there is hyperglycemia with dystrophic consequences underlying the diabetes symptomatology. Giving back new pancreatic islets has proven effective as a cure for diabetes type I, and is practiced today by transplantation of human islets obtained from pancreata donated from deceased donors. After 1 year 75% of transplanted patients are insulin-free, and 60% at 3 years (Vantyghem et al., 2009). The accumulated experience has established the proof of principle that islet transplantation is an effective clinical mean to free diabetes patients from the burden of daily insulin injections and strict diet. However, because of the limited availability of organ donation, only about 0.1 percent of diabetes type I patients can receive a transplant from post-mortem donors.
The progress in tissue engineering based on the capacity of human ES cell lines to differentiate into functional human tissues has open the road to manufacture human pancreatic islets in biotechnological plants. Kadimastem combines use of its licensed clinical grade hES cell line and of a differentiation technology in cell cultures, devoid of any genetic transformation, to produce human pancreatic islet cells having functional characteristics including glucose-regulated insulin-secretion. Kadimastem is in the process of expanding its production capacity to a large scale plant, employing robotized harvesting systems, to complete pre-clinical development.
An example of in vitro- produced human islet, manufactured at Kadimastem, is shown in the right panel, stained in red with antibodies detecting human insulin C-peptide, in comparison with an islet of Langerhans seen in the pancreatic tissue at the left.
The purified islets produced after hES differentiation may be used for transplantation as such or following encapsulation in a polymeric cage with pores allowing the influx of glucose and the outflow of insulin and other hormones, while protecting the graft from the host immune system.