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Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes

NCT03746769 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-23

No results posted yet for this study

Summary

This clinical study will evaluate the safety and effectiveness of Gastrin treatment with islet transplantation to help patients with difficult to control type 1 diabetes make insulin again and improve blood sugar control.

This study involves two investigational (experimental) products not yet approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease:

1. Human allogenic islet cells (islet cells from a deceased, unrelated human donor)
2. Gastrin-17 (Gastrin) - a hormone secreted by the gut

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

Allogenic Human Islet Cells

islet cells transplanted into the portal vein in the liver

DRUG

Gastrin 17

Gastrin-17 (or GAST-17) - a gut hormone injected under the skin twice daily for 30 days soon after islet transplant and again 6 months later. Also, anti-rejection medications (to prevent the body from rejecting the islet cells) and other medications to guard against infection and support participant health and/or the health of the transplanted islets.

Sponsors & Collaborators

Principal Investigators

  • Fouad Kandeel, MD, PhD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-07
Primary Completion
2028-08-01
Completion
2028-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03746769 on ClinicalTrials.gov