Primary objective: To describe and compare the safety and efficacy of treatment with AAT in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (TP-IAT).

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 pancreatectomy and islet auto-transplantation
• 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)

Deidentified dataset available for sharing with researchers

Available 01MAR2023 indefinitely

email to Wangho@musc.edu

All randomized participants who received total pancreatectomy with islet autotransplantation

1 year

Adverse events affecting >3% of the study population and all Serious Adverse Events were collected for 1 year after total pancreatectomy and included time during hospital stays. All participants had chronic abdominal pain at baseline that was prompting frequent hospitalizations. Two participants in the control arm and 3 persons in the MSC arm that withdrew consent and did not get surgery were not included in the adverse event denominator by prospective data safety analysis plan.