Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT00315614|
Recruitment Status : Terminated (We did not achieve a tolerogenic profile. Subjects withdrew from protocol and enrolled in other islet transplant trials.)
First Posted : April 18, 2006
Results First Posted : February 10, 2014
Last Update Posted : April 4, 2017
- 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
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Biological: Islet Transplantation and Bone Marrow||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Islet Cell Transplantation Alone and CD34+ Enriched Donor Bone Marrow Cell Infusion in Patients With Type 1 Diabetes Mellitus; Steroid Free Regimen|
|Study Start Date :||December 2000|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Islet Transplantation and Bone Marrow
Administration of islets and infusion of CD34 enriched Bone Marrow cells in subjects with type 1 diabetes, impaired awareness of hypoglycemia and severe hypoglycemia.
Biological: Islet Transplantation and Bone Marrow
Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes.
- The Achievement of Persistent Islet Function Following Cessation of Immunosuppression. [ Time Frame: for the duration of islet graft function ]Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.
- A Reduction or Absence of Rejection Episodes [ Time Frame: for the duration of islet graft function ]Number of rejection episodes after transplantation. Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.
- Number of Subjects With Basal C-peptide Greater Than 0.5 ng/ml [ Time Frame: for the duration of islet graft function ]Number of subjects with basal C-peptide greater than 0.5 ng/ml prior to weaning of immunosuppression;
- Number of Subjects With Reduction of Severe Hypoglycemia and Improvement in Hypoglycemia Awareness [ Time Frame: for the duration of islet graft function ]Number of subjects with reduction of episodes of severe hypoglycemia and the presence of awareness of hypoglycemia
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315614
|United States, Florida|
|Diabetes Research Institute|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Rodolfo Alejandro, MD||Diabetes Research Institute University of Miami|