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Recruiting

NCT Number: NCT03097185

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor University Medical Center - Sammons Outpatient Cancer Center

Dallas, Texas, 75246, United States

Location status: Recruiting

Location contact

Manager Clinical Research

CONTACT

[email protected]

214-820-1585

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic pancreatitis and who are scheduled for TP alone or TP-AIT
  • Patients aged 18 or older
  • Patients are able and willing to attend required follow-up visits at Baylor

Exclusion criteria

  • Patients who are unable/unwilling to attend follow-up visits at Baylor
  • 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.

Treatment and study plan

Primary outcomes

  1. Analysis of graft function following autologous islet transplantation

    Time frame: One year after transplant of islet cells.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne M Jones, BSN, RN

CONTACT

[email protected]

214-820-7623

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2017
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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