Microencapsulated Pancreatic Islet Allografts Into Nonimmunosuppressed Patients With Type 1 Diabetes
First two cases
- Riccardo Calafiore, MD1,
- Giuseppe Basta, MD1,
- Giovanni Luca, MD1,
- Angelo Lemmi, MD2,
- M. Pia Montanucci, PHD1,
- Giuseppe Calabrese, MD1,
- Leda Racanicchi, PHD1,
- Francesca Mancuso, PHD1 and
- Paolo Brunetti, MD1
- 1Department of Internal Medicine, University of Perugia, Perugia, Italy
- 2Department of Radiology and Imaging, University of Perugia, Perugia, Italy
- Address correspondence and reprint requests to Riccardo Calafiore, MD, Department of Internal Medicine, University of Perugia, Via E. Dal Pozzo, 06126 Perugia, Italy. E-mail: islet{at}unipg.it
Time-related decline of human islet allograft (TX) function in generally immunosuppressed type 1 diabetic patients (1–5) has led us, after years of preclinical study (6), to initiate a phase 1 pilot clinical trial of microencapsulated TX into 10 nonimmunosuppressed patients with type 1 diabetes, under permission and surveillance by the Italian Ministry of Health (file no. 19382, PRE 805, 5 September 2003).
RESEARCH DESIGN AND METHODS
Human islet procurement
Human islets were isolated from single-donor pancreases according to the Edmonton protocol (1). Only preparations complying with standard quality control criteria (1) were considered for TX. The islets were cultured for 24 h in HAM F12 (Celbio, Milano, Italy), supplemented with antibiotics and 1.25% human albumin (Kedrion Spa, Milano, Italy) at 37°C in 95% air/CO2.
Microencapsulation
The islets were washed and thoroughly mixed with 1.6% endotoxin- and pyrogen-free sodium alginate (Stern Italia, Milan, Italy) that had been highly purified according to U.S. Pharmacopeia. Upon extrusion …
