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NCT02567240 Clinical Trial

Carbon Monoxide-Saturated Medium for Islet Isolation

Chronic Pancreatitis Clinical Trial

Official title:
A Novel Approach to Harvest Islets for Autologous Islet Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02567240
Other study ID # Pro00040035
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2015
Est. completion date December 2018

Study information
Verified date January 2019
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 16
Est. completion date December 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria:

1. Chronic pancreatitis patient selected for total pancreatectomy and islet autotransplantation.

2. Age between 18-69.

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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Carbon monoxide-bubbled mediums
Islets will be harvested with carbon monoxide bubbled mediums

Locations
Country Name City State
United States GI Surgery, Medical University of South Carolina Charleston South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the curve during mixed meal tolerance test 6 months
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