Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021788
Status:
COMPLETED
Last Update Posted:
2010-07-09
First Post:
2001-08-04
Brief Title:
Islet Cell Transplantation Alone in Patients With Type I Diabetes Mellitus Steroid-free Immunosuppression
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:
Immunomodulation for Islet Transplantation in Diabetes
Status:
COMPLETED
Status Verified Date:
2010-07
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:
The goal of islet cell transplantation in patients with Type 1 Diabetes Mellitus is to provide constant normal blood glucose levels This may eliminate the need for insulin altogether or provide a significant reduction in the amount of insulin necessary to maintain constant normal blood glucose levels This normalization may prevent or slow progression of diabetic complications Furthermore the participant may enjoy a healthier lifestyle and a better quality of life
If you meet the initial inclusion criteria for the trial you must be able to give informed consent personally Then you will need to participate in an extensive screening process that involves many standard tests and collection of laboratory samples to make sure that the transplant is suitable and safe for you
If you meet the initial inclusion criteria for the trial you must be able to give informed consent personally Then you will need to participate in an extensive screening process that involves many standard tests and collection of laboratory samples to make sure that the transplant is suitable and safe for you
Detailed Description:
The trial maywill utilize the following immunosuppressive medications tacrolimus life-long sirolimus life-long daclizumab and infliximab You will be maintained on the lowest doses possible with all the medications
GROUP 1A The first four participants will be assigned to Group A These participants will receive an islet cell transplant alone from two donors They will receive the following immunosuppressive medications tacrolimus lifelong sirolimus lifelong and daclizumab They will not receive the immunosuppressive medication infliximab GROUP 1B The second four participants will be assigned to group B These participants will receive an islet cell transplant alone from one donor They will receive the following immunosuppressive medications tacrolimus lifelong sirolimus lifelong daclizumab and infliximab Patients in this group who are not able to stop injecting insulin by three months after the transplant may be eligible to receive a second islet cell transplant
Further participants will alternate group assignments in the same above-mentioned manner The participants in both groups will receive the following immunosuppressive medications for life tacrolimus and sirolimus All participants will be required to live no more than two hours from the transplantation center
When the islets become available you will be notified to come immediately to the hospital for your transplant At that time numerous tests and laboratory samples will be performed to make sure you are ready and healthy for your transplant
You will have your islet cell transplant done in a special radiology procedure room in a hospital You will have local anesthetic in the area of your liver on your right side along with sedatives that will minimize any discomfort the procedure might cause A very small thin needle will be inserted through your liver into your portal vein where the islet cells are then injected
All participants will need to be followed at the Diabetes Research Institute after transplant for laboratory sampling testing and for general islet cell transplant care
GROUP 1A The first four participants will be assigned to Group A These participants will receive an islet cell transplant alone from two donors They will receive the following immunosuppressive medications tacrolimus lifelong sirolimus lifelong and daclizumab They will not receive the immunosuppressive medication infliximab GROUP 1B The second four participants will be assigned to group B These participants will receive an islet cell transplant alone from one donor They will receive the following immunosuppressive medications tacrolimus lifelong sirolimus lifelong daclizumab and infliximab Patients in this group who are not able to stop injecting insulin by three months after the transplant may be eligible to receive a second islet cell transplant
Further participants will alternate group assignments in the same above-mentioned manner The participants in both groups will receive the following immunosuppressive medications for life tacrolimus and sirolimus All participants will be required to live no more than two hours from the transplantation center
When the islets become available you will be notified to come immediately to the hospital for your transplant At that time numerous tests and laboratory samples will be performed to make sure you are ready and healthy for your transplant
You will have your islet cell transplant done in a special radiology procedure room in a hospital You will have local anesthetic in the area of your liver on your right side along with sedatives that will minimize any discomfort the procedure might cause A very small thin needle will be inserted through your liver into your portal vein where the islet cells are then injected
All participants will need to be followed at the Diabetes Research Institute after transplant for laboratory sampling testing and for general islet cell transplant care
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DK55347 | None | None | None |