Carbon Monoxide-Saturated Medium for Islet Isolation

A Novel Approach to Harvest Islets for Autologous Islet Transplantation

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02567240

Enrollment

Registered

2015-10-02

Start date

2015-01-31

Completion date

2018-12-31

Last updated

2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis

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.

Interventions

OTHERCarbon monoxide-bubbled mediums

Islets will be harvested with carbon monoxide bubbled mediums

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Area under the curve during mixed meal tolerance test	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026