Improving Islet Transplantation Outcomes With Gastrin
This clinical study will evaluate the safety and effectiveness of Gastrin treatment with islet transplantation to help patients with difficult to control type 1 diabetes make insulin again and improve blood sugar control. This study involves two investigational (experimental) products not yet approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease: 1. Human allogenic islet cells (islet cells from a deceased, unrelated human donor) 2. Gastrin-17 (Gastrin) - a hormone secreted by the gut
• Age 18-68 years
• Type 1 diabetes mellitus (documented with fasting C-peptide level of \</= 0.2 ng/ml before and \</= 0.3 ng/ml after IV administration of 1 mg of glucagon) for at least 5 years.
• Unstable blood glucose characterized by:
• Frequent hypoglycemia (blood glucose less than or equal to 54 mg/dl more than once per week)
⁃ and/or- Hypoglycemia unawareness (Clarke score of 4 or more).
⁃ and/or- One or more severe hypoglycemic episodes in 12 months preceding enrollment
⁃ and/or- Erratic blood glucose levels that interfere with daily activities
⁃ and/or- One or more hospital visits for diabetic ketoacidosis in the 12 months preceding enrollment
• Ability and willingness to comply with post-transplant regimen, including immunosuppression, use of reliable contraception, frequent clinic visits, testing and maintaining detailed logs of blood glucose levels, insulin doses and medications, and completing detailed follow-up studies.
• Ability to give informed consent.
• Fully vaccinated against COVID-19