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CompletedNCT02567240Updated Jan 4, 2019

Carbon Monoxide-Saturated Medium for Islet Isolation

A Phase 1/2 interventional study of Carbon monoxide-bubbled mediums in Chronic Pancreatitis, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2019-01-04.

Sponsored by Medical University of South Carolina · Phase 1/2, Interventional, and Other

Phase
Phase 1/2
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Pancreatitis
03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 16 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Carbon monoxide-bubbled mediums

    Islets will be harvested with Carbon monoxide-saturated mediums

    Other: Carbon monoxide-bubbled mediums

  • No intervention
    Normal mediums

    Islets will be harvested with regular mediums

Interventions

  • OtherCarbon monoxide-bubbled mediums

    Islets will be harvested with carbon monoxide bubbled mediums

06

What researchers measure

Primary outcomes

  1. Area under the curve during mixed meal tolerance test

    Time frame: 6 months

07

Study locations

1 site
  • GI Surgery, Medical University of South Carolina
    Charleston, South Carolina 29425, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02567240
Lead sponsor
Medical University of South Carolina
Responsible party
Sponsor
First posted
Oct 2, 2015
Start date
Jan 2015
Primary completion
Oct 2018
Completion
Dec 2018
Last update
Jan 4, 2019

Study contacts

Hongjun Wang, Ph.D
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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