Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021801
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2001-08-04
Brief Title:
Islet Cell Transplantation Alone and CD34 Enriched Bone Marrow Cell Infusion in Patients With Diabetes Mellitus Steroid-Free Regimen
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:
Pathways to Tolerance in Human Islet Transplantation
Status:
COMPLETED
Status Verified Date:
2010-03
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 Type 1 diabetics is to provide those affected with constant normal blood glucose levels thereby reducing or eliminating altogether the need for injected insulin This normalization may prevent or slow progression of diabetic complications result in a healthier lifestyle and lead to a better quality of life
Participants who meet the inclusion criteria will undergo an extensive screening process which typically includes a series of blood tests EKG chest x-rays and a psychological evaluation among others Those who are eligible for and chose to participate in the trial will receive an islet cell transplant and bone marrow infusion from the same donor together with following immunosuppressive medications tacrolimus sirolimus daclizumab and infliximab Because the bone marrow infusion may successfully prevent the transplanted islet cells from rejecting some participants may be able to stop taking the immunosuppressive medications after a year
The islet cell transplant is done under local anesthesia in a special procedure radiology room Several days after the islet cell transplant the participant is admitted to the hospital as an outpatient in order to receive bone marrow via a simple intra-venous infusion procedure
All participants will need to be seen at the Diabetes Research Institute after the transplant for follow-up testing and post-islet cell transplant care
Participants who meet the inclusion criteria will undergo an extensive screening process which typically includes a series of blood tests EKG chest x-rays and a psychological evaluation among others Those who are eligible for and chose to participate in the trial will receive an islet cell transplant and bone marrow infusion from the same donor together with following immunosuppressive medications tacrolimus sirolimus daclizumab and infliximab Because the bone marrow infusion may successfully prevent the transplanted islet cells from rejecting some participants may be able to stop taking the immunosuppressive medications after a year
The islet cell transplant is done under local anesthesia in a special procedure radiology room Several days after the islet cell transplant the participant is admitted to the hospital as an outpatient in order to receive bone marrow via a simple intra-venous infusion procedure
All participants will need to be seen at the Diabetes Research Institute after the transplant for follow-up testing and post-islet cell transplant care
Detailed Description:
None
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 |
|---|---|---|---|
| DK56953-01 | None | None | None |