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Analysis of Graft Function Following Autologous Islet Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03097185
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : February 12, 2018
Information provided by (Responsible Party):
Baylor Research Institute

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Analysis of Graft Function Following Autologous Islet Transplantation
Actual Study Start Date : June 3, 2010
Estimated Primary Completion Date : November 7, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Analysis of graft function following autologous islet transplantation [ Time Frame: One year after transplant of islet cells. ]

Biospecimen Retention:   Samples Without DNA
Each subject will provide samples of blood at specific timepoints as outlined in the protocol

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03097185

Sponsors and Collaborators
Baylor Research Institute
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Principal Investigator: Ernest E Beecherl, MD Sammons Cancer Center, Baylor University Medical Center

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Responsible Party: Baylor Research Institute Identifier: NCT03097185     History of Changes
Other Study ID Numbers: 010-150
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baylor Research Institute:
islet cell
Additional relevant MeSH terms:
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Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases