Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)
The purpose of this protocol is to provide continued acess to immunosuppressive medications to subjects from the completed/closed trial ITN005CT (NIS01,NCT00014911). THIS PROTOCOL DOES NOT PROVIDE MEDICINES TO DIABETES PATIENTS WHO DID NOT PARTICIPATE IN ITN005CT.
Diabetes Mellitus, Type 1
Drug: Mycophenolate mofetil
Drug: Mycophenolic acid
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||Immunosuppressive Medications for Previous Participants in Clinical Trial ITN005CT (NCT00014911)|
Islet transplantation is an experimental therapy in people with difficult to control Type 1 diabetes (T1D). Insulin producing cells (islets) are isolated from a pancreas. After the cells are prepared, the islets are put into the subject's liver. These transplanted islets may produce insulin that the subject's islets can no longer make. In order to help keep up the function of the transplanted islets, immunosuppressive medications must be given indefinitely or for as long as the study doctor determines is necessary. The medications serve to modify the immune system that normally tries to destroy (reject) new islets.
Participants in this study have received up to three islet cell infusions as a previous participant in the ITN005CT (NIS01) protocol. They also received a maintenance immunosuppressive treatment regimen consisting of a combination of orally administered drugs (tacrolimus (Prograf®), sirolimus (Rapamune®), mycophenolate mofetil (MMF, Cellcept®), and/or mycophenolic acid (MPA, Myfortic®).) This protocol provides a way to supply these immunosuppressive medications to subjects whose islets continue to function and make C-peptide.
Routine study follow-up visits will occur on an annual and -as warranted basis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309022
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Study Chair:||Daniel C. Brennan, MD||Washington University School of Medicine|