Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:17 AM
Study NCT ID:
NCT00303134
Status:
TERMINATED
Last Update Posted:
2019-06-03
First Post:
2006-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Islet Cell Transplants for Diabetes
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Human Islet Cell Transplantation in Type 1 Diabetic Patients
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor intermediate-term results
Has Expanded Access:
No
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 the safety and efficacy of islet cell transplants for the treatment of type 1 diabetes mellitus. It has been shown that normal control of blood sugar levels can prevent progression of complications (such as kidney disease, nerve damage, and vascular disease) from diabetes. This research study is designed to see if normal blood sugar control can be achieved by transplanting pancreatic islet cells into your liver, which may reduce or eliminate your need for insulin. Patients may qualify to participate in this research study if they have type 1 diabetes mellitus for at least five years and meet at least one of the following criteria:
* Experience hypoglycemic unawareness - Defined as inability to tell when blood glucose is low (for example, may not feel symptoms such as shaking, sweating, and rapid heartbeat that usually signify that glucose is low)
* Have been hospitalized several times in the past year for low blood sugar and/or high blood sugar
* Have complications of diabetes such as retinopathy, kidney problems, or neuropathy
* Experience hypoglycemic unawareness - Defined as inability to tell when blood glucose is low (for example, may not feel symptoms such as shaking, sweating, and rapid heartbeat that usually signify that glucose is low)
* Have been hospitalized several times in the past year for low blood sugar and/or high blood sugar
* Have complications of diabetes such as retinopathy, kidney problems, or neuropathy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: