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Carbon Monoxide-Saturated Medium for Islet Isolation

Phase 1
Completed
Conditions
Chronic Pancreatitis
Interventions
Other: Carbon monoxide-bubbled mediums
Registration Number
NCT02567240
Lead Sponsor
Medical University of South Carolina
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
Inclusion Criteria
  1. Chronic pancreatitis patient selected for total pancreatectomy and islet autotransplantation.
  2. Age between 18-69.
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Exclusion Criteria
  1. 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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Carbon monoxide-bubbled mediumsCarbon monoxide-bubbled mediumsIslets will be harvested with Carbon monoxide-saturated mediums
Primary Outcome Measures
NameTimeMethod
Area under the curve during mixed meal tolerance test6 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

GI Surgery, Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

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