Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437398
Status:
TERMINATED
Last Update Posted:
2013-04-25
First Post:
2007-02-20
Brief Title:
Islet Transplantation for Type 1 Diabetes Mellitus
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Islet Transplantation for Type 1 Diabetes Mellitus
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early due to difficulty in recruiting subjects and ran short of funds
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The complex program of insulin replacement for type 1 diabetes that is current clinical standard of care is difficult to implement for long periods of time associated with an increased risk of severe hypoglycemia and implemented by less than 50 of the population of such patients Outcomes of transplantation of isolated human islets have substantially improved and been performed at about 40 institutions around the world We are proposing a clinical phase 1phase 2 study of islet transplantation alone evaluating safety and efficacy in five patients with type 1 diabetes Islet isolation from deceased donor pancreases will be performed at the Mayo Rochester Islet Isolation facility and islets infused by Interventional Radiology into the portal venous system Following islet infusion patients will be hospitalized for 48 hours in the General Clinical Research Center GCRC or at the Rochester Methodist Hospital Multiple safety and efficacy outcomes will be followed on multiple occasions during the first year and periodically thereafter
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1RR024150 | NIH | None | httpsreporternihgovquickSearchUL1RR024150 |