1146-P: Persistent Graft Function after Islet Allotransplantation Into Prevascularized Sernova Cell Pouch Device: Preliminary Results from the University of Chicago
| Autor: | Piotr Witkowski, Angelica Perez-Gutierrez, Jayant Kumar, Laurencia Perea, Piotr J. Bachul, Louis H. Philipson, Gabriela S. Generette, Jordan Pyda, Karolina Golab, Peter Borek, Celeste C. Thomas, Lindsay Basto, Braden Juengel, Martin Tibudan, John J. Fung |
|---|---|
| Rok vydání: | 2021 |
| Předmět: | |
| Zdroj: | Diabetes. 70 |
| ISSN: | 1939-327X 0012-1797 |
| Popis: | Introduction: Pre-vascularized Sernova Cell Pouch (SCP) device was developed to provide an optimal environment for cell/islet engraftment in the extravascular space. A first-in-human pilot study showed SCP safety/islet vascularization; however, conditions did not allow detectable islet function. We present preliminary results of phase I/II study testing safety and efficacy of modified SCPs in islet allotransplantation (ITx). Material and Methods: 6 patients with longstanding T1DM and multiple severe hypoglycemic events (SHEs) were enrolled. Immunosuppression (Thymoglobulin, Tacrolimus, and Mycophenolate) was initiated 3 weeks after abdominal wall SCP surgical implantation. ITx occurred at 3 weeks and 6 months after implantation. Sentinel SCPs were explanted for histopathological evaluation 3 months after transplant. Islet graft function was assessed based on continuous glucose monitoring (CGM), c-peptide, and insulin requirement. Results: First patient presented with persistent stimulated serum c-peptide at 6 months after 1st and 2nd ITx into SCP. After 2nd ITx, glucose control improved substantially reaching optimal target values for CGM with only 5% of Time Below Range (TBR). Second patient at 3 months after 2nd ITx had positive stimulated serum c-peptide (0.48 ng/mL) with reduction of HbA1c from 10.6% to 7.6%, decreased insulin requirement from 49 to 28 u/day, improved CGM with TBR Conclusion: Persistent islet graft function with sustained blood levels of c-peptide, reduction of HbA1c, improved CGM parameters, reduction of SHEs, and decreased total daily insulin requirement was achieved in first 2 patients after ITx into abdominal wall SCPs. Modified approaches, including suspending islets in serum, optimizing islets/dose, and smaller pellet volumes, will likely improve engraftment and outcomes. Disclosure P. J. Bachul: None. B. Juengel: None. J. Kumar: None. C. C. Thomas: None. L. H. Philipson: Advisory Panel; Self; Nevro Corp., Research Support; Self; Provention Bio, Inc. J. Fung: None. P. Witkowski: None. G. S. Generette: None. J. S. Pyda: None. P. Borek: None. A. Perez-gutierrez: None. K. Golab: None. L. Basto: None. L. Perea: None. M. Tibudan: None. Funding JDRF; Sernova, Corp. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|