Clinical Trials
The Faustman Lab's clinical trial is currently testing whether using Bacillus Calmette-Guérin (BCG), a generic drug that temporarily elevates TNF levels in the body, will reduce or eliminate autoimmune T cells in patients with type 1 diabetes.
The trial’s Phase I funding is complete and the trial is in progress under the direction of Denise Faustman, MD, PhD, and David Nathan, MD, director of the MGH Diabetes Center.
The trial, scheduled for completion by January 2010, will gather information on drug safety. Subsequent Phase II trials will focus on determining the optimal dose and timing of BCG administration to achieve the desired effects in type 1 diabetes. Phase I trials are aimed at proving the drug is safe.
While this trial is underway, we need to begin planning for our Phase II clinical trial, which we hope to launch upon the successful completion of the Phase I portion. The Phase II trial will involve testing BCG in greater numbers of patients with type 1 diabetes using the dose and timing we determine from the Phase I data. 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). We are currently screening volunteers for the Phase II trial. Please e-mail us directly at if you have any questions about the trials.
A major part of the Phase II planning involves raising the funds needed to conduct this next stage of human research, and we have set a fund-raising goal of $25 million. Make a gift today to support our research.
