Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260234
Status:
TERMINATED
Last Update Posted:
2014-09-09
First Post:
2005-11-28
Brief Title:
Safety and Efficacy of PEG-Encapsulated Islet Allografts Implanted in Type I Diabetic Recipients
Sponsor:
Novocell
Organization:
Novocell
Study Overview
Official Title:
A Single-Center Phase III Study Of Peg-Encapsulated Islet Allografts Implanted In Patients With Type I Diabetes
Status:
TERMINATED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped in December 2007
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Insulin dependent Type I diabetics require daily insulin therapy to normalize blood glucose but may have difficulty with significant glycemic excursions and hypoglycemic episodes and crises Islet cell transplantation can provide relief from daily insulin therapy normalize blood glucose and reduce or eliminate short and long-term diabetes-related complications PEG-Encapsulated Islet Allografts is a new islet transplant product under development that does not require the ongoing use of immunosuppressive drugs after the implant This study will test the safety and efficacy of PEG-Encapsulated Islet Allografts in the treatment of Type I diabetes and provide functional outcome measurements
Detailed Description:
Allogeneic Cultured Islet Cells human Novocell Encapsulated in Polyethylene Glycol Administered Subcutaneously are a combination biologic and device product in which the pharmacologically active agent is human insulin that is released from the functional islet cells by natural production and release stimulated by control mechanisms in response to blood glucose concentrations The device component is a uniform and conformal polymer coating around each islet Islet cells are isolated from multiple human pancreases procured from human organ donors who meet a specific human donor profile established by the UNOS and the FDAs requirements for Good Tissue Practices Because the pancreases used for islet cell isolation are not intended for whole-organ transplantation specific procurement surgical removal packaging and shipping protocols are provided by Novocell Inc to the Organ Procurement Organizations
The primary outcome is demonstration that encapsulated islet allografts can be implanted safely in the subcutaneous tissues without the use of long-term immunosuppression The expected functional outcomes from the implantation of the encapsulated islets are significant reductions in the average blood glucose daily glycemic excursions and in insulin requirements as well as significant increases in C-peptide levels in response to meal challenges The ultimate expected outcome is that patients who receive these implants will have reduced hemoglobin A1c levels that may be associated with reduced long-term diabetic complications An important outcome should be reduction in hypoglycemic episodes and crises with significantly functioning grafts without having the risks associated with hepatic portal vein infusion and long-term immunosuppression
The primary outcome is demonstration that encapsulated islet allografts can be implanted safely in the subcutaneous tissues without the use of long-term immunosuppression The expected functional outcomes from the implantation of the encapsulated islets are significant reductions in the average blood glucose daily glycemic excursions and in insulin requirements as well as significant increases in C-peptide levels in response to meal challenges The ultimate expected outcome is that patients who receive these implants will have reduced hemoglobin A1c levels that may be associated with reduced long-term diabetic complications An important outcome should be reduction in hypoglycemic episodes and crises with significantly functioning grafts without having the risks associated with hepatic portal vein infusion and long-term immunosuppression
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 |
|---|---|---|---|
| WIRB 20041068 | None | None | None |