Hum Posted June 28, 2011 Share Posted June 28, 2011 ScienceDaily (June 28, 2010) ? Massachusetts General Hospital (MGH) and the Iacocca Foundation have announced the completion of the Phase I BCG clinical trial in type 1 diabetes, as well as the submission of all safety reports to the U.S. Food and Drug Administration (FDA) and the MGH data safety monitoring boards. Plans for the Phase II clinical study, which will continue the investigation of bacillus Calmette-Guerin (BCG) vaccination as a treatment for people with existing type 1 diabetes, are actively underway. The results of the MGH trial showed that low-dose, multi-dosing regimens of BCG vaccination were safe in individuals with type 1 diabetes. There were no severe reactions to the vaccine other than the expected inflammation at the injection sites. The basis of the trial is preclinical work done in the Faustman Immunobiology Laboratory, as well as other laboratories worldwide, showing that temporarily elevating levels of an immune modulator called tumor necrosis factor (TNF) can eliminate the abnormal white blood cells found in mice and humans with type 1 diabetes. The trial will seek to define the exact dose and timing of administration of BCG vaccination to treat advanced type 1 diabetes. The majority of the funds for Faustman's basic research, on which these human studies are based, have come from the Iacocca Foundation. Additional information about the clinical trials can be found at http://www.faustmanlab.org. more Link to comment Share on other sites More sharing options...
Rudy Posted June 28, 2011 Share Posted June 28, 2011 I saw it on the news tonight.... pretty cool :) Too bad it won't be available for a long time but at least there's some hope Link to comment Share on other sites More sharing options...
neoadorable Posted June 28, 2011 Share Posted June 28, 2011 awesome news and hope this really does work, it will alleviate a lot of suffering. why would it take long? if it passes trials it shouldn't be more than a couple of years before production can commence. of course tomorrow or today would be better! Link to comment Share on other sites More sharing options...
Hum Posted June 28, 2011 Author Share Posted June 28, 2011 ^ Drug tests need to find out what side-effects may happen over a long period of time, plus what may happen to a wide range of people. Age, sex, race, etc. Drug makers are also concerned with minimizing lawsuits, if anything goes wrong. Link to comment Share on other sites More sharing options...
Teebor Posted June 28, 2011 Share Posted June 28, 2011 ^ Drug tests need to find out what side-effects may happen over a long period of time, plus what may happen to a wide range of people. Age, sex, race, etc. Drug makers are also concerned with minimizing lawsuits, if anything goes wrong. Given how long the BCG has been around and the number of people it has been given too I would think this would be a minor hurdle. Maybe some small trials since it is being repurposed. Link to comment Share on other sites More sharing options...
Growled Member Posted June 28, 2011 Member Share Posted June 28, 2011 Awesome news. This will help so many people. Link to comment Share on other sites More sharing options...
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