Immunosuppression and Negative Side Effects
For a generation, there have been experiments with many different drugs and combinations of drugs to suppress the body's immune system to provide survival of a transplanted organ in a new human host. To date, there have been no successes with immunosuppression drugs in protecting transplanted islet cells in a new diabetic host. Most common immunosuppression drugs have proven toxic to islet cells.
There was briefly hope, through research in the noteworthy Edmonton Trials, that non-steroidal-based immunosuppression would be successful with transplanted islet cells. Unfortunately, the initial successes which included reversal of diabetes turned out to be a disappointment. The experimental drugs triggered mass-mutation of other body cells and an out-break of cancers.
The point remains that ANY use of immunosuppression drugs poses serious side-effects that are often more dangerous and threatening to the recipient than diabetes, and makes the patient vulnerable to a range of infectious diseases.
In a landmark study published in The New England Journal of Medicine, September 28, 2006, both the promise of islet cell transplant to reverse diabetes, and the highly negative side-effects of immunosuppression drugs, were affirmed:
- 44% of 36 subjects achieved insulin independence with adequate glycemic control 1 year after the final transplantations,
- of a total of 38 serious adverse events, 23 were considered to be related to the study therapy (18 of which were associated with hospitalization). Serious immunosuppression-related events included neutropenia (five cases), pneumonia, mouth ulcers, gastrointestinal conditions (two cases), fever, chest pain, pericardial effusion, pyelonephritis, worsening genital herpes, and appendiceal abscess.
The premise for Encapsulife's functional cure approach has been proven in parts by other research trials of other organizations where there were partial successes. In particular, reports of the 1999 - 2000 Edmonton Studies, demonstrated that diabetes reversal could be achieved by implanting islet cells with use of immunosuppression drugs. Regrettably, the cocktail of immunosuppression used in the Edmonton studies, while enabling islet cell functionality, inflicted highly negative side-effects on the diabetic patients.
Encapsulife's immunoisolation process has proven entirely benign to host patients and is a significant improvement over the Edmonton research experience because Encapsulife's approach does not involve any immunosuppression therapies.
Progress Toward Protecting Islet Cells In the Diabetic Host
ANY foreign tissue inserted or transplanted into the human body triggers the body's immune system to attack and defeat the foreign tissue. "Rejection" occurs when the tissue (a donated organ, for example) is defeated by the new host's immune system. Historically, there have been two means of protecting the new donated tissue in the new host: immunosuppression and immunoisolation.
Encapsulife's Solution: Immunoisolation of Transplanted Islet Cells
Immunoisolation is achieved by encapsulating pancreatic Beta cells within a multi-layered microscopic polymer capsule, and then transplanting these encapsulated cells into the new host with a simple 15-minute laproscoptic procedure. The encapsulated Beta cells are anchored but not attached in the peritoneal cavity of the new host where there is sufficient fluid exchange to provide nutrients to the encapsulated islets, as well as triggers to the encapsulated islets to produce insulin. The insulin, which by itself in the body does not trigger an autoimmune reaction, is absorbed into the blood stream to bond with glucose and provide energy and growth to each and every cell of the human host. Through repeated trials, the polymer components of immuno-isolation capsules 97% water and 3% cellulose are completely benign to the host.