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

Medical University of South Carolina (MUSC)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Chronic Pancreatitis

Treatments

Drug: Placebo

Drug: Prolastin-C

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02947087

Pro00053906

5R01DK105183 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)