Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306098
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2006-03-17
Brief Title:
Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus Steroid-Free Immunosuppression
Sponsor:
Rodolfo Alejandro
Organization:
University of Miami
Study Overview
Official Title:
Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus Steroid-Free Immunosuppression
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
SPECIFIC AIMS
1 To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation
2 To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1 Diabetes Mellitus by islet cell transplantation
3 To assess long-term safety and function of successful islet cell transplants in patients with Type 1 Diabetes Mellitus
4 To determine whether the natural history of the microvascular macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells and
5 To assess the effect of infliximab in preventing early islet destruction and thereby eliminating the need for a second donors islet cells
6 To assess the effect of etanercept in preventing early islet destruction
7 To assess the effect of exenatide to improve islet graft function and survival in subjects that have returned to using exogenous insulin
8 To assess the ability of exenatide to improve islet survival at time of transplantation
1 To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation
2 To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1 Diabetes Mellitus by islet cell transplantation
3 To assess long-term safety and function of successful islet cell transplants in patients with Type 1 Diabetes Mellitus
4 To determine whether the natural history of the microvascular macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells and
5 To assess the effect of infliximab in preventing early islet destruction and thereby eliminating the need for a second donors islet cells
6 To assess the effect of etanercept in preventing early islet destruction
7 To assess the effect of exenatide to improve islet graft function and survival in subjects that have returned to using exogenous insulin
8 To assess the ability of exenatide to improve islet survival at time of transplantation
Detailed Description:
This Phase II trial will have 3 groups Group A will receive islets from 2 donors and will not receive infliximab Group B will receive in addition to Daclizumab Sirolimus and Tacrolimus a dose of infliximab and islets from a single donor as per the Edmonton protocol Everything else about the clinical trial will be the same for both groups The first 4 patients will be assigned to Group A the next 4 patients to Group B the next 4 patients to Group A and the next 4 patients to Group B total 16 Patients in Group A will receive 1-2 transplants with cells from 2 donors If the second donor pancreas is received and satisfactory at the same time as the first pancreas one islet infusion will be used to infuse cells from both donors If the second pancreas is not received until after the first transplantation a second islet infusion will be done A second course of five doses of Daclizumab will be started on the day of the second islet infusion
In order to determine if prolonged administration of etanercept in combination with transplantation of cultured islets will prevent TNF-α production and enhance engraftment we have added Group C to the current protocol Group C in addition to Daclizumab Sirolimus and Tacrolimus will receive Etanercept in the peri-transplant period and islets from one or more donors The last 24 patients included in this Protocol will be in Group C if they are new or in Group A and B Supplemental Infusion if they had previous transplants Any Group A or B participants who are eligible for a supplemental infusion will receive etanercept but no infliximab
In order to determine if prolonged administration of etanercept in combination with transplantation of cultured islets will prevent TNF-α production and enhance engraftment we have added Group C to the current protocol Group C in addition to Daclizumab Sirolimus and Tacrolimus will receive Etanercept in the peri-transplant period and islets from one or more donors The last 24 patients included in this Protocol will be in Group C if they are new or in Group A and B Supplemental Infusion if they had previous transplants Any Group A or B participants who are eligible for a supplemental infusion will receive etanercept but no infliximab
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 |
|---|---|---|---|
| No Number | OTHER_GRANT | Diabetes Research Institute Foundation Miami Florida | None |
| NIH 1U42 RR016603-01 | None | None | None |
| HRSA 1 R38OT01367-01-00 | None | None | None |