Improving Islet Transplantation Outcomes With Gastrin
City of Hope Medical Center
Summary
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
Description
Islet cell transplantation involves transplanting the cells that make insulin from a pancreas of deceased organ donor to a patient with diabetes. Because there is a limited supply of donor islet cells available, this study is testing whether Gastrin injections can help make a fewer number of transplanted islets work better. Gastrin is a natural gut hormone that is present in the pancreas during its development in the embryo but not after birth, and is believed to participate in the formation of the normal pancreas. Several studies have tried to use gastrin to help grow insulin making islet ce…
Eligibility
- Age range
- 18–68 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18-68 years 2. 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. 3. 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 -…
Interventions
- BiologicalAllogenic Human Islet Cells
islet cells transplanted into the portal vein in the liver
- DrugGastrin 17
Gastrin-17 (or GAST-17) - a gut hormone injected under the skin twice daily for 30 days soon after islet transplant and again 6 months later. Also, anti-rejection medications (to prevent the body from rejecting the islet cells) and other medications to guard against infection and support participant health and/or the health of the transplanted islets.
Location
- City of Hope Medical CenterDuarte, California