A patient, randomized, placebo-controlled, Phase II clinical trial is currently fully enrolled and all patients have been followed for at least one year. Other clinical studies include those related to ongoing on biomarker development, BCG strain comparison, drug stability with different BCG formulation formats, systemic glucose utilization with radiography and, soon, expanded studies into additional autoimmune diseases. Pending funding and FDA approval, MGH is planning several additional human clinical trials, including pediatric trials and trials in a broader selection of patients with longstanding type 1 diabetes.
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All of the patients in the studies showed a durable and significant improvement in HbA1c. BCG Brochure. In cancer, the immune system is tricked into not attacking the cancerous cells. The Faustman lab identified a population of regulatory immune cells essential to turning the immune system back on.
This has led to the generation of a novel class of antibodies specific to the tumor microenviromonment. Other basic science research in our lab is focused on the tumor necrosis factor receptor 2 TNFR2 pathway.
One of our fundamental basic science findings in the human is that the TNFR2 surface receptor is an identifying surface protein of the most potent Tregs, and that the TNFR2 pathway is an important signaling pathway for adult Treg fate.
Based on these findings, our lab has been making and testing unique antibodies for TNFR2 with the goal of identifying antibodies that can lead to human Treg proliferation and depletion, which may have future applications in immunotherapy for both autoimmunity and cancer. Our clinical research program is investigating whether repeat vaccination with a generic vaccine—called the bacillus Calmette-Guerin, or BCG, vaccine—can eliminate abnormal T cells, induce beneficial human regulatory T cells Tregs and reverse established type 1 diabetes in humans.
Positive data from our Phase I study in humans were published in Most trials testing immune interventions in type 1 diabetes are conducted in new-onset diabetics. This clinical trial program is unique in focusing on patients with established, rather than newly diagnosed, type 1 diabetes.
It is also unique in being a nonprofit drug development program supported solely through philanthropic donations from the public and nonprofit organizations , as well as in seeking diabetes reversal using an inexpensive generic drug.
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