Back to resultsCarbon Monoxide-Saturated Medium for Islet Isolation
Primary Purpose
Chronic Pancreatitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Carbon monoxide-bubbled mediums
Sponsored by
About this trial
This is an interventional other trial for Chronic Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Chronic pancreatitis patient selected for total pancreatectomy and islet autotransplantation.
- 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.
Sites / Locations
- GI Surgery, Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Carbon monoxide-bubbled mediums
Normal mediums
Arm Description
Islets will be harvested with Carbon monoxide-saturated mediums
Islets will be harvested with regular mediums
Outcomes
Primary Outcome Measures
Area under the curve during mixed meal tolerance test
Secondary Outcome Measures
Full Information
NCT ID
NCT02567240
First Posted
October 1, 2015
Last Updated
January 2, 2019
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02567240
Brief Title
Carbon Monoxide-Saturated Medium for Islet Isolation
Official Title
A Novel Approach to Harvest Islets for Autologous Islet Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbon monoxide-bubbled mediums
Arm Type
Experimental
Arm Description
Islets will be harvested with Carbon monoxide-saturated mediums
Arm Title
Normal mediums
Arm Type
No Intervention
Arm Description
Islets will be harvested with regular mediums
Intervention Type
Other
Intervention Name(s)
Carbon monoxide-bubbled mediums
Intervention Description
Islets will be harvested with carbon monoxide bubbled mediums
Primary Outcome Measure Information:
Title
Area under the curve during mixed meal tolerance test
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic pancreatitis patient selected for total pancreatectomy and islet autotransplantation.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongjun Wang, Ph.D
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
GI Surgery, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
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Carbon Monoxide-Saturated Medium for Islet Isolation
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