Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073281
Status:
COMPLETED
Last Update Posted:
2010-01-15
First Post:
2003-11-18
Brief Title:
Islet Transplantation for Patients With Type 1 Diabetes
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Islet Transplantation for Patients With Type 1 Diabetes and Stable Renal Allografts Using Steroid Sparing Immunosuppression
Status:
COMPLETED
Status Verified Date:
2010-01
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:
This protocol will test whether Type 1 diabetes T1DM can be reversed in patients with stable renal allografts by islet transplantation
Detailed Description:
We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be transplanted into the portal vein of patients with T1DM who have stable renal allografts to achieve insulin independence for the recipient The protocol will employ a defined islet isolation procedure percutaneous islet infusion into the recipients portal vein via an intra-portal catheter tight glycemic control during the peri-transplant period and an immunosuppressive protocol that avoids glucocorticoids
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