Analysis of Graft Function Following Autologous Islet Transplantation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03097185

Enrollment

100

Registered

2017-03-31

Start date

2010-06-03

Completion date

2026-12-31

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis

Keywords

pancreatitis, islet cell

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactAnne M Jones, BSN, RN

anne.jones@bswhealth.org214-820-7623

Outcome results