Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315614
Status:
TERMINATED
Last Update Posted:
2017-04-04
First Post:
2006-04-14
Brief Title:
Islet Cell Transplantation Alone and CD34 Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Islet Cell Transplantation Alone and CD34 Enriched Donor Bone Marrow Cell Infusion in Patients With Type 1 Diabetes Mellitus Steroid Free Regimen
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We did not achieve a tolerogenic profile Subjects withdrew from protocol and enrolled in other islet transplant trials
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SPECIFIC AIMS
To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes mellitus by islet cell transplantation
To induce a state of donor specific tolerance and eliminate the need for continuous immunosuppressive therapy by simultaneous transplantation of donor bone marrow cells with islets and utilization of the monoclonal antibody Campath-1H for induction of Immunosuppression
To assess long-term function of successful islet cell transplants in patients with Type 1 diabetes mellitus
To determine whether the natural history of the microvascular macrovascular and neuropathic complications are altered following successful transplantation of islet
To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes mellitus by islet cell transplantation
To induce a state of donor specific tolerance and eliminate the need for continuous immunosuppressive therapy by simultaneous transplantation of donor bone marrow cells with islets and utilization of the monoclonal antibody Campath-1H for induction of Immunosuppression
To assess long-term function of successful islet cell transplants in patients with Type 1 diabetes mellitus
To determine whether the natural history of the microvascular macrovascular and neuropathic complications are altered following successful transplantation of islet
Detailed Description:
In our current protocol IRB 20000024 the immunosuppressive regimen comprised of induction with daclizumab and maintenance therapy with sirolimus and tacrolimus has been combined with the infusion of CD34 enriched donor bone marrow stem cells in an attempt to create a chimeric state and hence induce donor tolerance This strategy was tested by evaluating graft survival following the removal of all immunosuppressive medication after one year
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 |
|---|---|---|---|
| R01DK056953 | NIH | None | httpsreporternihgovquickSearchR01DK056953 |