Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014911
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2001-04-13
Brief Title:
Islet Transplantation for Type 1 Diabetes
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Islet Transplantation for Type 1 Diabetic Patients Using the Edmonton Protocol of Steroid Free Immunosuppression ITN005CT
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test whether the islet cell transplantation procedures and results from a previous study in Edmonton Canada can be repeated The study also is designed to learn more about diabetes control using islet cell transplantation
This is a Phase III study a study that examines effectiveness and looks for side effects The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal despite intensive insulin therapy A recent study conducted in Edmonton Canada was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated This study extends the results obtained from the Edmonton study which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression
This is a Phase III study a study that examines effectiveness and looks for side effects The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal despite intensive insulin therapy A recent study conducted in Edmonton Canada was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated This study extends the results obtained from the Edmonton study which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression
Detailed Description:
This is a Phase III study a study that examines effectiveness and looks for side effects The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal despite intensive insulin therapy A recent study conducted in Edmonton Canada was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated This study extends the results obtained from the Edmonton study which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression
Eligible patients were randomly selected from the total pool of people who applied through the Immune Tolerance Network Patients will receive at least 10000 islet equivalents per kilogram 22 pounds of body weight This likely will require 2 separate islet infusions from 2 separate donors Immediately before the first transplant patients will be given anti-rejection immune suppressing drugs including tacrolimus and sirolimus orally and daclizumab intravenously The islets will be infused into the liver through a tube placed in the portal vein Heparin a medication to prevent blood clots will be administered with the islet infusion A longer-acting form of heparin will also be given by daily injections during the next week after each transplant After surgery patients will receive insulin intravenously for 24 hours Patients will have an abdominal ultrasound and blood tests to determine liver function If fewer than 10000 islets were transplanted patients will continue insulin treatment with the dosages adjusted if necessary to account for the transplanted islets They will take daclizumab every 2 weeks for 8 weeks and tacrolimus and sirolimus daily Patients will be given antibiotics to prevent infections Blood tests to determine how much immunosuppressant drug is in the blood will be performed until the drug is at a stable level Periodically there will be tests to see if the islet cells are functioning Blood will be drawn to check drug levels and for other tests routinely Daily insulin requirements will be checked and these will be recorded monthly Patients will be followed for at least 1 year post last islet transplantation Additional follow-up may be provided at least annually for up to 9 years post first transplantation
Eligible patients were randomly selected from the total pool of people who applied through the Immune Tolerance Network Patients will receive at least 10000 islet equivalents per kilogram 22 pounds of body weight This likely will require 2 separate islet infusions from 2 separate donors Immediately before the first transplant patients will be given anti-rejection immune suppressing drugs including tacrolimus and sirolimus orally and daclizumab intravenously The islets will be infused into the liver through a tube placed in the portal vein Heparin a medication to prevent blood clots will be administered with the islet infusion A longer-acting form of heparin will also be given by daily injections during the next week after each transplant After surgery patients will receive insulin intravenously for 24 hours Patients will have an abdominal ultrasound and blood tests to determine liver function If fewer than 10000 islets were transplanted patients will continue insulin treatment with the dosages adjusted if necessary to account for the transplanted islets They will take daclizumab every 2 weeks for 8 weeks and tacrolimus and sirolimus daily Patients will be given antibiotics to prevent infections Blood tests to determine how much immunosuppressant drug is in the blood will be performed until the drug is at a stable level Periodically there will be tests to see if the islet cells are functioning Blood will be drawn to check drug levels and for other tests routinely Daily insulin requirements will be checked and these will be recorded monthly Patients will be followed for at least 1 year post last islet transplantation Additional follow-up may be provided at least annually for up to 9 years post first transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None