Analysis of Graft Function Following Autologous Islet Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Pancreatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Analysis of graft function following autologous islet transplantation [Time frame: One year after transplant of islet cells.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Baylor University Medical Center - Sammons Outpatient Cancer Center — Dallas
Identifiers
NCT: NCT03097185 · 010-150