Analysis of Graft Function Following Autologous Islet Transplantation

Chronic Pancreatitis Clinical Trial

Official title:

Analysis of Graft Function Following Autologous Islet Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03097185
• Other study ID #: 010-150
• Status: Active, not recruiting
• Phase: N/A
• First received: March 27, 2017
• Last updated: February 8, 2018
• Start date: June 3, 2010
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2018
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of graft function following autologous islet transplantation		One year after transplant of islet cells.