Islet Cell Transplantation Alone and CD34+ Enriched Bone Marrow Cell Infusion in Patients With Diabetes Mellitus: Steroid-Free Regimen
|ClinicalTrials.gov Identifier: NCT00021801|
Recruitment Status : Completed
First Posted : August 6, 2001
Last Update Posted : March 2, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Procedure: Islet Cell Transplantation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Pathways to Tolerance in Human Islet Transplantation|
|Study Start Date :||March 2000|
|Study Completion Date :||September 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021801
|United States, Florida|
|University of Miami Diabetes Research Institute|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Rodolfo Alejandro, MD||University of Miami Diabetes Research Institute|