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ECIT-1: CNI-free Immunosuppression for Islet Transplantation in T1D
NCT01346085Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2006
- Primary completion
- Jun 2009
- Countries
- 2
- Sponsor
- IRCCS Ospedale San Raffaele
- Modality
- Nanoparticles, Cytokines & Interferons, Small Molecules
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 2, open-label trial of nab-sirolimus, mycophenolate mofetil, antithymocyte globulin rabbit and anakinra in type 1 diabetes mellitus (T1D), sponsored by IRCCS Ospedale San Raffaele. Started Oct 2006; status: completed.
02
Design
- Study design
- Non-randomizedOpen-labelSingle group
03
Registry description
Our final objective is to develop an adoptive therapy with tolerogenic donor-specific Tr1 cells in T1D patients undergoing pancreatic islet transplantation (Tx). The achievement of this objective depends by the availability of an immunosuppressive treatment (IS) compatible with the survival, function, and expansion of the transferred Tr1 cells. For this purpose the investigators design a CNI-free single-group, phase 1-2 trial excluding the ATG or anti-CD25 induction therapy after the 1st islet infusion
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