An inexpensive vaccine that’s been used for over 90 years to combat tuberculosis may have the ability to reverse type 1 diabetes. Although the early results were met with skepticism, seven studies in mice over the last ten years have established that the generic drug BCG (bacillus Calmette-Guerin) can prevent immune system T cells from destroying insulin-producing cells, allowing the pancreas to regenerate and once again produce insulin.
A research team from the Massachusetts General Hospital Immunobiology Laboratory led by Dr. Denise Faustman, PhD, successfully reproduced the results in a small group of human subjects, using very small doses of the vaccine. Those diabetics receiving the vaccine, all of whom had been Type 1 for an average 15 years, showed both a decrease in pancreas cell-destroying T cells, and an increase in the insulin precursor C-peptide – an indicator of insulin production.
The results were temporary, and it is likely that the vaccination would have to be repeated on a regular basis. The team believed using higher doses would have led to a more positive effect, but trial dosages were limited by the FDA. They are now negotiating with the FDA to use higher concentrations in a larger trial.
Type 1 diabetes is an auto-immune condition in which the body attacks its own insulin-producing beta cells in the pancreas. The body needs insulin to fuel itself and regulate blood sugar, so type 1 diabetics must take daily insulin injections to manage their blood sugar levels.
BCG works by increasing the levels of an immune system protein called tumor necrosis factor, or TNF. High levels of TNF block other parts of the immune system from attacking the body, especially the pancreas. This is a major shift in direction in diabetes treatment, as it was not previously believed possible to restore pancreas function in insulin dependent diabetics.
Doctors and researchers are surprised and excited at the unanticipated prospect of controlling the immune system to restore the body’ ability to produce normal insulin levels. “If this is reproducible and correct, it could be a phenomenal finding,” enthuses Dr. Robert Henry of the University of California, San Diego.
The research was largely funded by the Iacocca Foundation, founded in 1984 by auto manufacturer magnate Lee Iacocca and his daughters after his wife died from diabetes complications at age 57. The Foundation has committed to continued financial assistance for phase II clinical testing of the potentially revolutionary diabetes medication.