Modification of the "Edmonton Protocol" to Allow for Successful Islet Transplantation From a Single Pancreas and Extension of the "Edmonton Protocol" to Kidney Transplant Recipients (Project 1 of JDFI Washington University Center for Islet Transplantation)
18 Years
65 Years
Both
Diabetes Mellitus
Trial Information
Modification of the "Edmonton Protocol" to Allow for Successful Islet Transplantation From a Single Pancreas and Extension of the "Edmonton Protocol" to Kidney Transplant Recipients (Project 1 of JDFI Washington University Center for Islet Transplantation)
We anticipate that successful islet transplantation will establish a group of islet cell
transplant patients who have normal blood sugars and do not need insulin injections. Some
of this group will have received a kidney transplant as well. All these patients will be
studied in great detail along with other investigators in our islet cell program to
understand better the mechanisms of efficacy and side effects of islet transplant and these
new immunosuppressive drugs.
Inclusion Criteria:
Type 1 diabetes for > 5 years AND Hypoglycemia unawareness, not felt adequately by patient
(glucose < 54mg/dL) in last 1.6 years, not otherwise explained, requiring outside help OR
Metabolic lability/instability, characterized by hypoglycemia or ketoacidosis (>2 hospital
< 12 mo), chaotic glucose profile (MAGE > 120mg/dL), disruption in lifestyle or danger to
life, to self, to others OR Failure of intensive insulin management, as judged by an
independent endocrinologist.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Federal Government
Study ID:
NCRR-M01RR00036-0775
NCT ID:
NCT00021580
Start Date:
Completion Date:
Related Keywords:
- Diabetes Mellitus
- Diabetes Mellitus
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
