A new form of immunotherapy for Type 1 diabetes, developed by scientists at the University of California-San Francisco (UCSF) has successfully cleared its phase 1 trial.
Type 1 diabetes affects the insulin-secreting cells, called beta cells, in the pancreas. The new therapy uses specially modified T-cells called as Tregs that have the potential to inhibit the immune system's attack on beta cells while leaving its infection-fighting capabilities intact. The findings have been published in the Science Translational Medicine
‘A new immunotherapy uses specially modified T-cells known as Tregs that have the potential to prevent the immune system's attack on beta cells without changing its ability to fight infections.’
"This could be a game-changer. For type 1 diabetes, we've traditionally given immunosuppressive drugs, but this trial gives us a new way forward. By using Tregs to 're-educate' the immune system, we may be able to really change the course of this disease," said Jeffrey A. Bluestone, first author of the study.
The scientists derived these special Tregs from the participants own body cells itself. They removed about two cups of blood from Type 1 diabetes participants. These patients usually have 2-4 million of the desired Tregs. A method called Fluorescence-activated cell sorting (FACS), the therapeutic Tregs are separated and then placed into a growth medium in which they can attain a 1,500-fold increase in number.
Researchers isolated 14 diabetic patients into four groups and the large population of Tregs were infused back into the patient's body. In addition to being well tolerated by all four groups, the treatments were durable, with up to 25 percent of the infused therapeutic cells still detectable in patients' circulation a year after they had received just a single infusion.
"Using a patient's own cells -- identifying them, isolating them, expanding them, and infusing them back into the patient -- is an exciting new pillar for drug development and we expect Tregs to be an important part of diabetes therapy in the future," said Bluestone.
Reference: Jeffrey A. Bluestone, Jane H. Buckner et al, "Type 1 diabetes immunotherapy using polyclonal regulatory T cells," Science Translational Medicine, 25 Nov 2015:Vol. 7, Issue 315, pp. 315ra189, DOI: 10.1126/scitranslmed.aad4134