Type 1 diabetes was known as infant-juvenile diabetes since it began in the child and adolescent era, however there is a growing percentage of people who begin to suffer from it after 30 years.
This diabetes requires injected insulin treatment and daily glucose control at different times of the day.The cause of type 1 diabetes is still unknown, and it cannot be prevented with current knowledge.
Your treatment could change from here to a few years thanks to a new essay that will see the light soon.It is a phase II clinical trial that analyzes the capacity of the generic vaccine of the Calmette-Guérin (BCG) bacillus to reverse the advance of type 1 diabetes has received the approval of the American drug agency (FDA)in English).
The approval of this essay, which will soon begin to recruit patients, will announce it this Sunday at the 75th Scientific Session of the American Diabetes Association (ADA) the Director of the Immunobiology Laboratory of the General Hospital of Massachusetts (MGH, for its acronym in English) and main researcher of the study, Denise Faustman.
The five -year trial will investigate whether repeated vaccination with BCG can clinically improve type 1 diabetes in adults between 18 and 60 years of age who have small but still detectable levels of insulin secretion of the pancreas.The Faustman research team was the first group to document the reversal of advanced diabetes type 1 in mice and subsequently completed clinical trials in phase I in humans of the BCG vaccine.
"We have learned a lot from the first studies in mice, not only about how the BCG works, but also on its possible therapeutic benefits, similar to what is being seen in the tests against other autoimmune diseases. We are very grateful to allDonors, large and small, who have made this analysis possible.This year, "says Faustman.
A generic medicine with more than 90 years of clinical use and safety data, the BCG is currently approved by the FDA for vaccination against tuberculosis and for the treatment of bladder cancer.It is known that the vaccine raises the levels of the immune modulator tumor necrosis factor (TNF), that the Faustman team previously showed that it can temporarily eliminate in humans and mice the abnormal white cells of the blood responsible for type 1 diabetesAutoimmuneThe increase in TNF levels also stimulates the production of regulatory T cells.
In phase I of clinical trials, which was published on August 8, 2012 in the magazine 'Plos Medicine', two BCG injections in four -week spaces aimed at the temporal elimination of T cells that cause diabetes, they provided evidenceof a small transitory change in insulin secretion.The phase II clinical study will include a more frequent dosage during a longer period of time to determine the potential of repeated BCG vaccination to improve the autoimmune state and clinical parameters such as HBA1C, a marker that indicates the average level ofblood sugar.
150 patients will be vaccinated
In the new essay, which will be double blind and made in MGH, 150 adults with type 1 diabetes during long term will be randomly assigned to receive two two -week BCG or placebo injections and then a single annual injection over the next four years.HEIt will monitor patients closely during the five -year test period.The first result that will be measured will be the improvement of the figures in the HBA1C blood test, which has been shown to prevent complications.
"In phase I of clinical trials, a statistically significant response of the BCG was seen, but our goal in phase II is to create a lasting therapeutic response," explains Faustman, associate professor of Medicine at Harvard Medicine School, statesJoined.
"We are going to work again with people who have had type 1 diabetes for many years. This is not a prevention trial; we are trying to create a regime that tries the disease, even in an advanced stage. In addition to our phase I trial,We are guiding BCG clinical trials that are underway worldwide for other autoimmune diseases such as multiple sclerosis, "he adds.
Lee Iacocca, founder of the Iacocca Foundation, says: "My family and I have been lucky enough to be part of this research for many years. It is very exciting to be talking about the healing of people, not mice. I made a promise to my deceasedwife to find a cure for type 1 diabetes. Now my family and I hope that progress will continue and we are proud to support this effort to approach that goal. "The IACOCCA Foundation provided important financing for the phase I study and has assumed a leadership role in the financing of phase II test.
