Carbon Monoxide-Saturated Medium for Islet Isolation

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Pancreatitis

Treatments: Other: Carbon monoxide-bubbled mediums

Study type: Interventional

Funder types: Other

Identifiers

NCT02567240

Pro00040035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Carbon monoxide-bubbled mediums

Experimental group

Description:

Islets will be harvested with Carbon monoxide-saturated mediums

Treatment:

Other: Carbon monoxide-bubbled mediums

Normal mediums

No Intervention group

Description:

Islets will be harvested with regular mediums