Carbon Monoxide-Saturated Medium for Islet Isolation

The goal of this study is to determine whether harvesting islets using carbon monoxide (CO)-saturated mediums can protect islet cell from death after autologous islet transplantation in patients with chronic pancreatitis.

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Key information

Conditions

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

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GI Surgery, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

Investigators plan to harvest human islets using carbon monoxide-saturated mediums. Survival and function of transplanted islets will be compared with islets harvested using regular mediums.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Chronic pancreatitis patient selected for total pancreatectomy and islet autotransplantation.
Age between 18-69.

Exclusion criteria

Had prior pancreatic surgeries.

Note: The study was initially designed only to enroll diabetes free patients. To increase enrollment, we extended the inclusion criteria by allowing patients who are pre-diabetic to participate the study. This revision was approved by the MUSC IRB on 11/10/2015.

Treatment and study plan

Carbon monoxide-bubbled mediums

Other

Islets will be harvested with carbon monoxide bubbled mediums

Primary outcomes

Area under the curve during mixed meal tolerance test

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

A Novel Approach to Harvest Islets for Autologous Islet Transplantation

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Oct 2, 2015
Registry last updated: Jan 4, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed