A London company may be on the verge of a groundbreaking treatment for diabetes. A mini pancreas pouch could begin human clinical trials within a year….
In the last few years a procedure kn����������������;Edmonton Protocol” has been used to treat diabetes by transplanting human islet cells from organ donors into patients. Although the procedure is quite successful it faces two major issues:
- The critical lack of organ donors means only a handful of people with diabetes can be treated in any given year. In the United States, there are approximately 6,000 cadaveric organ donors and only a fraction of the available pancreatic tissue is suitable for transplantation. For each patient receiving the transplant there must be at least two donors.
- Patients receiving the transplants must stay on anti-rejection drugs for the rest of their lives to keep their immune systems from destroying the transplanted cells. The serious side effects of perpetually compromising a person’s immune system means that generally only those people experiencing serious complications receive the transplants. Younger, healthier diabetics who have the most to gain from preventing any more damage by the disease also have the most to lose by living the rest of their lives with suppressed immune systems.
The Cell Pouch System™ has shown long-term efficacy in small animal models, and is currently being tested in the product designed for patients in a large animal model of diabetes supported by a $465,000 in-kind contribution from the National Research Council of Canada. With reduced cost of implantation, increased safety and improved efficacy relative to other cell therapy treatments, this therapy could reduce or eliminate the need for insulin injections in an ever increasing number of patients. The timeline to FDA approval of a medical device is shorter than pharmaceuticals with a higher success rate. Using the device regulatory pathway, Sernova has the potential to have products on the market in a shorter period of time than competing pharmaceutical technologies.
The first clinical indication for the Cell Pouch System™ is anticipated to be for patients with pancreatitis. Patients with severe pancreatitis who have their pancreas removed will become diabetic. These patients could benefit by having their islets removed from the pancreas and placed into the Cell Pouch System™ with the hope of restoring glucose control. Product expansion may then occur through treatment of diabetic patients with the Cell Pouch System™ with immunosuppressant agents or with Sertolin™ cells that provide an immune-protected environment for the islets.
Sertolin is based on the Sertoli cells’ natural ability to locally modulate the immune system. Sertoli cells, which are normally found in the testes, synthesize cytokines and growth factors necessary to protect and mature developing spermatozoa. It has been known for more than 60 years that it is possible to transplant cells from different species into the testes without them being rejected. Dr. Helena Selawry discovered that the presence of Sertoli cells is the principal reason for this long-recognized immunologically privileged environment of the testes and that became the basis for the Sertoli patents.
Using the patented Sertoli cells and a medical device inserted under the skin of the patient’s abdomen, an immunoprivileged environment is created, in which a second cell type (e.g. insulin producing islets) can be co-transplanted without the need for immunosuppression. Therefore diabetic patients are treated with a minimally invasive day surgery, resulting in a reduced need for insulin or even total insulin independence. The procedure may also prove to have many other cellular co-transplantation or gene therapy applications.
How the Sernova Corporation’s pouch works for diabetes treatment:
- A “cell pouch” is implanted under the skin in the belly of the patient.
- Islets planted in the pouch produce insulin naturally, in response to the blood sugar levels in the patient.
- Islets are cells from the pancreas, extracted from a donor, creating a mini pancreas.
- The pouch is not visible on the patient.
- Animal tests have seen the device work well for six months.
- Human clinical trials may begin in about one year.