Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis

The goal of this study is to assess whether infusion of Prolastin-C during peri-transplant
period can enhance islet autograft survival and function in chronic pancreatitis patients who
have total pancreatectomy and islet autotransplantation. This is a prospective, controlled,
double-blind study. The primary endpoint will be area under the curve for the serum C-peptide
level during the first 4 hours of an mixed meal tolerance test (MMTT), normalized by the
number of islet equivalents (IEQ)/kg at day 365±14 after the transplant.

Inclusion Criteria:

- Patients scheduled for total pancreactectomy and islet autotransplantation

- Age > 18 years

- Diabetes free before surgery

Exclusion Criteria:

- Patients who are under immunosuppression

- Patients who have had puestow or frey pancreatic surgery

- Patients who have Immunoglobulin A (IgA) deficiency, known antibodies against IgA, or
individuals with a history of severe immediate hypersensitivity reactions, including
anaphylaxis to Alpha1-proteinase inhibitor products (allergic to AAT)