Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT00706420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2008-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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 evaluate the safety and effectiveness of islet cell transplantation alone (ITA) in patients with difficult to control type I diabetes. Difficult to control type 1 diabetes is defined as wide swings in blood glucose that disrupt the patient's life and result in frequent episodes of low blood glucose despite the proper use of standard insulin therapy and frequent blood glucose monitoring.
Detailed Description:
Type 1 diabetes is associated with the damage of a specific cell subtype of pancreatic islets (clusters of cells in the pancreas that produce insulin and other metabolic hormones), which makes patients depend on an outside source of insulin. Despite insulin treatment, type 1 diabetes mellitus causes a significant risk of long-term problems, including damage to the heart, blood vessels, nerves, eyes and kidneys. The results of recent research studies suggest that these complications are caused by poor glucose control.
Transplantation of islets offers the prospect of good glycemic (blood glucose) control without the major surgical risks associated with whole pancreas transplant and may result in not needing any insulin injections. In 2000, a group of investigators in Edmonton, Canada showed that islet transplantation using a combination of anti-rejection drugs to help prevent the rejection of transplanted islets was effective in eliminating insulin intake in 7 subjects who were followed up to 20 months. After 5 years, more than 60 patients have been transplanted at Edmonton and only 1 in 10 remained off of insulin.
This study is being performed to confirm the results of the Edmonton study to see if islet transplantation alone (ITA) is a safe and effective way of treating subjects with type 1 diabetes. This study uses a few additional medications and vitamin supplements that were not included in the original Edmonton study. We hope this will improve the long-term outcome of islet transplantation.
Transplantation of islets offers the prospect of good glycemic (blood glucose) control without the major surgical risks associated with whole pancreas transplant and may result in not needing any insulin injections. In 2000, a group of investigators in Edmonton, Canada showed that islet transplantation using a combination of anti-rejection drugs to help prevent the rejection of transplanted islets was effective in eliminating insulin intake in 7 subjects who were followed up to 20 months. After 5 years, more than 60 patients have been transplanted at Edmonton and only 1 in 10 remained off of insulin.
This study is being performed to confirm the results of the Edmonton study to see if islet transplantation alone (ITA) is a safe and effective way of treating subjects with type 1 diabetes. This study uses a few additional medications and vitamin supplements that were not included in the original Edmonton study. We hope this will improve the long-term outcome of islet transplantation.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RR-01-002 | None | None | View |