NCT03097185Recruiting

Analysis of Graft Function Following Autologous Islet Transplantation

Baylor Research Institute

Start Date

6/3/2010

Completion Date

12/1/2026

Summary

Analyze inflammatory markers and islet graft function through blood samples collected from subjects with chronic pancreatitis who undergo total pancreatectomy with auto islet transplantation.

Detailed Description

A total of 100 subjects will be enrolled in this study; 85 subjects will be enrolled from patients who are scheduled for TP-AIT and 15 subjects will be for TP alone at Baylor University Medical Center at Dallas or Baylor All Saints Medical Center at Fort Worth. The patients who are enrolled in a clinical study, named 'A phase 2/3, multicenter, randomized, double-blind, placebo-controlled, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet auto-transplantation (REP0112, IND# 117390)', can be enrolled in this study.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Patients with chronic pancreatitis and who are scheduled for TP alone or TP-AIT 2. Patients aged 18 or older 3. Patients are able and willing to attend required follow-up visits at Baylor Exclusion Criteria: 1. Patients who are unable/unwilling to attend follow-up visits at Baylor 2. For TP-AIT subjects: Patients who have advanced stage of chronic pancreatitis. The principal investigator or co-investigators carefully review the medical charts, laboratory results and radiology department reports and determine the suitability for this study.

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Conditions

Chronic Pancreatitis

Locations

Baylor University Medical Center - Sammons Outpatient Cancer Center

Dallas, Texas 75246

United States