Clinical Trials
The BCG Human Clinical Trial Program is testing whether using Bacillus Calmette-Guérin (BCG), an inexpensive generic drug that temporarily elevates TNF levels in the body, will reduce or eliminate the disease-causing T cells in patients living with type 1 diabetes.
Under the direction of Denise Faustman, MD, PhD, director of the MGH Immunology Lab, and David Nathan, MD, director of the MGH Diabetes Center, an FDA-approved, Phase I human clinical trial was conducted and demonstrated that vaccination with BCG is safe in individuals with type 1 diabetes. The next step is to conduct a Phase II study, in which we will need to identify the “best” dose of BCG and the best schedule for giving this potential new therapy and achieving the desired effects.
The Phase II trial will involve testing BCG in greater numbers of patients with type 1 diabetes. It will also give us more information on how effective this treatment might be, providing the information needed to launch late-stage human clinical trials (Phase III studies). Please e-mail us directly at DiabetesTrial@partners.org if you have any questions about the trials.
There are an estimated 1 million Americans living with type 1 diabetes today, many of them children. We hope our approach will provide a new, safer, less costly treatment option or even cure for these individuals, one that may relieve them of the need to have multiple daily insulin injections or wear an insulin pump. This program also offers new hope for those in less developed countries, where the introduction of affordable diabetes treatments could mean the difference between life and death.
We are currently raising the funds to conduct this next stage of human research. Our fundraising goal is $25.2 million. Please make a gift today to support our research.