Analysis of Graft Function Following Autologous Islet Transplantation

NCT03097185 | Recruiting DMC

• 1 other identifier: 010-150
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Keywords

pancreatitis; islet cell

Outcome Measures

Primary Outcomes (1)

• Analysis of graft function following autologous islet transplantation

  One year after transplant of islet cells.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center - Sammons Outpatient Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Each subject will provide samples of blood at specific timepoints as outlined in the protocol

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ernest E Beecherl, MD

  Sammons Cancer Center, Baylor University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne M Jones, BSN, RN

CONTACT

214-820-7623; anne.jones@bswhealth.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: June 3, 2010
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (1)