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

  • End date
    Dec 24, 2021
  • participants needed
  • sponsor
    Medical University of South Carolina
Updated on 24 January 2021
alpha-1 antitrypsin


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 36514 after the transplant.

Condition Chronic pancreatitis
Treatment Placebo, Prolastin-C
Clinical Study IdentifierNCT02947087
SponsorMedical University of South Carolina
Last Modified on24 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic pancreatitis?
Do you have any of these conditions: Do you have Chronic pancreatitis??
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)
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