Human trials to begin on 'diabetes cure' after terminally ill mice are returned to health
Human trials to begin on 'diabetes cure' after terminally ill mice are returned to health
By NOEL YOUNG
Last updated at 23:30 14 March 2008
Most diabetes sufferers could be cured within four years if a revolutionary treatment involving the BCG vaccine works, scientists said yesterday.
A human clinical trial with hopes of finding a cure for type 1 diabetes is to start at a leading American research hospital using BCG, universally given for many years in Britain to prevent tuberculosis.
If all goes well in later trials, the treatment could be approved for ordinary patients in four years.
Volunteer patients are now being enrolled for the trial at at Massachusetts General Hospital in Boston.
The aim is to find out whether promising results obtained by Dr Denise Faustman in mouse studies can be applied to human diabetes.
Her studies have shown that mice with a form of diabetes closely resembling type 1 diabetes in humans can be cured. ÏHundreds of mice were involved in a number of experiments over a period of years," said Dr Faustman.
"All were suffering from type 1 diabetes with only about two weeks to live."
ÏThey started improving within days after the first injection of BCG was given, and were eventually free of diabetes."
The vaccine destroyed abnormal white blood cells obstructing the production of insulin, which is needed to prevent diabetes, she said.
The first step in the human study is to determine whether the same strategy using BCG vaccination can be used to modify the abnormal autoimmune cells present in type 1 diabetes, sometimes called Ïjuvenile-onsetÓ diabetes.
ÏWe are pleased to be starting human clinical trials,Ó said Dr Faustman.
ÏWe are making the step from curing diabetes in mice to determining whether it will work in men and women with diabetes.Ó
Mouse blood is very similar to human blood and a clue as to whether the vaccine programme is working could be available within months of the start of the trial.
ÏOne of the beautie of this is that BCG is a drug that has been tried and tested for 80 years, Ï said Dr Faustman.
ÏThere is no multi- million-dollar drug approval pipeline. It is a generic drug and will be cheap to administer if it works for humans.Ó
Type 1 diabetes usually starts during childhood or adolescence when a person's immune system attacks and destroys the insulin-producing cells in the pancreas.
Complications can include kidney failure, blindness, amputations, heart disease, and strokes. The risk of complications is closely linked to the elevated blood sugar levels.
Maintaining near-normal sugar levels requires life-long demands on the patient, including frequent blood sugar monitoring and at least three daily injections of insulin or use of an insulin pump, along with restrictive diets.
Dr Faustman, a diabetes researcher for 15 years, realised that reversing Type 1 diabetes would require a drug that killed the bad white blood cells.
Going over years of records, she identified BCG, one of whose side effects in combatting TB is that it does just that.
Type two diabetes, which is an adult-onset illness often linked to obesity, is a different disease and not likely to be affected by the American trial.
