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Nitrite Infusion in Islet Cell Transplantation

NCT03544242 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-10-29

Study results available
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Summary

This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation.

Conditions

Interventions

OTHER

Control

A saline infusion will be administered during the pre-isolation and post-isolation phases.

DRUG

Pre-Isolation Infusion

A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.

DRUG

Post-Isolation Infusion

A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Blair Smith, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-07
Primary Completion
2019-06-27
Completion
2019-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03544242 on ClinicalTrials.gov