The provisional results of a clinical trial approved by the American drug agency (FDA) to study the generic vaccine of the Calmette-Guérin bacillus (BCG) reveal its potential mechanism to reverse advanced type 1 diabetes, asIt highlights in its presentation at the 75th scientific session of the American Diabetes Association.
The data demonstrates a new potential mechanism by which the BCG vaccine can restore the appropriate immune response of the cells of the insulin of the pancreas.The findings suggest that the BCG can induce a permanent increase in the expression of genes that restore the beneficial regulatory T cells (TREGS) that prevent the immune system from attacking the body's own tissue.
"Many groups are studying the ability of vaccination with BCG to reverse autoimmunity,"Some time ago the restoration of beneficial TREG cells could stop abnormal self-reactivity in type 1 diabetes and other autoimmune diseases, but therapies to restore this immune balance have not achieved lasting results. "
Restoration of cells that control autoimmunity
"BCG restores the TREGS through epigenetics, a process that modulates whether the genes are expressed or not, which provides a better idea of how vaccination with BCG seems to function powerfully managing the induction of treg and resetting the immune system to stopThe underlying cause of the disease, "he details.
Type 1 diabetes is an autoimmune disease characterized by the destruction of islets by self -reactive T cells, which attack the islets erroneously as if they were an infection.The TREG are the "brakes" of the immune system that normally prevent poorly directed attacks against tissues without cushioning the entire system.Several research groups have suggested methods to introduce or expand TREGS in patients with type 1 diabetes, but to date therapies have not been approved.
Better known for its role in the prevention of tuberculosis, the BCG vaccine is based on a harmless strain of bacteria related to that caused by tuberculosis.A generic treatment with more than 100 years of clinical use and safety data, BCG is currently approved by FDA for vaccination against tuberculosis and for the treatment of bladder cancer.Multiple international studies are currently investigating the potential for the repetition of BCG vaccines to prevent and reverse autoimmune diseases including type 1 diabetes and multiple sclerosis.
"BCG is interesting because it puts into play so many areas of immunology that we as a community have been looking for for decades, including TREGS and the hygiene hypothesis-says Faustman-. The repetition of vaccination with BCG seems to permanently activate the signature ofTREG genes and the beneficial effect of the vaccine on the immune response of the guest recapitulate decades of human coevolution with myocobacteria, a relationship that has been lost with modern food and life habits.The key to stop these terrible diseases. "
Faustman's research team was the first group to document the reversal of advanced type 1 diabetes in mice and subsequently completed a successful clinical trial in humans in vaccination phase I with BCG.Phase II trial of 150 people and five years is investigating whether BCG vaccination repetition can improveClinically type 1 diabetes in adults with existing disease.The long -term follow -up data of the phase I trial will be published at the end of this year and the phase II trial is fully financed by the private philanthropy of individuals and family foundations.