Carbon Monoxide-Saturated Medium for Islet Isolation

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT02567240
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jan 1, 2015
• Actual Primary Completion Date: Oct 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Area under the curve during mixed meal tolerance test [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GI Surgery, Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

• Principal Investigator: Hongjun Wang, Ph.D, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT02567240
• Other Study ID Numbers: Pro00040035
• First Posted: Oct 2, 2015
• Last Update Posted: Jan 4, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic; Carbon Monoxide

Study Results

No Results Posted as of Jan 4, 2019