NCT02567240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3.8 years

First QC Date

October 1, 2015

Last Update Submit

January 2, 2019

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Area under the curve during mixed meal tolerance test

    6 months

Study Arms (2)

Carbon monoxide-bubbled mediums

EXPERIMENTAL

Islets will be harvested with Carbon monoxide-saturated mediums

Other: Carbon monoxide-bubbled mediums

Normal mediums

NO INTERVENTION

Islets will be harvested with regular mediums

Interventions

Carbon monoxide-bubbled mediumsOTHER

Islets will be harvested with carbon monoxide bubbled mediums

Carbon monoxide-bubbled mediums

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. Had prior pancreatic surgeries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GI Surgery, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hongjun Wang, Ph.D

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 2, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

US(1)