Analysis of Graft Function Following Autologous Islet Transplantation

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

Study Overview

• Status: Unknown
• Conditions: Chronic Pancreatitis

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study plans to enroll a total of 100 patients for this study; 85 patients who will undergo with TP-AIT and 15 patients with TP alone.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Analysis of graft function following autologous islet transplantation	One year after transplant of islet cells.

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Ernest E Beecherl, MD, Sammons Cancer Center, Baylor University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2010
• Primary Completion (Anticipated): November 7, 2018
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: pancreatitis; islet cell
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: 010-150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No