Carbon Monoxide-Saturated Medium for Islet Isolation | NCT02567240

Studies
Carbon Monoxide-Saturated Medium for Islet Isolation

NCT02567240

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Jan 4, 2019Actual

Enrollment

16Actual

Phase

Phase 1Phase 2

Conditions

Chronic Pancreatitis

Interventions

Carbon monoxide-bubbled mediums

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Oct 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Oct 1, 2015

First Submission Date that Met QC Criteria

Oct 1, 2015

First Posted Date

Oct 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2019

Last Update Posted Date

Jan 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Carbon monoxide-bubbled mediums	Other	Islets will be harvested with carbon monoxide bubbled mediums	Carbon monoxide-bubbled mediums

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hongjun Wang, Ph.D	Medical University of South Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GI Surgery, Medical University of South Carolina		Charleston	South Carolina	29425	United States

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided