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Carbon Monoxide-Saturated Medium for Islet Isolation

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ClinicalTrials.gov Identifier: NCT02567240
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Other: Carbon monoxide-bubbled mediums Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: A Novel Approach to Harvest Islets for Autologous Islet Transplantation
Study Start Date : January 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Carbon monoxide-bubbled mediums
Islets will be harvested with Carbon monoxide-saturated mediums
Other: Carbon monoxide-bubbled mediums
Islets will be harvested with carbon monoxide bubbled mediums

No Intervention: Normal mediums
Islets will be harvested with regular mediums



Primary Outcome Measures :
  1. Area under the curve during mixed meal tolerance test [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567240


Locations
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United States, South Carolina
GI Surgery, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Hongjun Wang, Ph.D Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02567240     History of Changes
Other Study ID Numbers: Pro00040035
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs