RecruitingPhase 1Phase 2NCT03746769

Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes

Improving Islet Transplantation Outcomes With Gastrin

Sponsor

City of Hope Medical Center

Enrollment

20 participants

Start Date

Jul 7, 2019

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

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

Eligibility

Min Age: 18 YearsMax Age: 68 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a hormone called gastrin, given alongside an islet cell transplant, can help the transplanted cells work better and improve blood sugar control in people with Type 1 diabetes who have dangerous, hard-to-control low blood sugar episodes. **You may be eligible if...** - You have had Type 1 diabetes for at least 5 years - You have unstable blood sugar, including frequent dangerous low blood sugar episodes (below 54 mg/dL more than once a week), unawareness of low blood sugar, or a severe low blood sugar episode in the past year - You are aged 18–68 years - You are being considered for an islet cell transplant **You may NOT be eligible if...** - Your diabetes is well controlled or stable - You have significant kidney disease, heart disease, or liver problems - You have active infections or a history of certain cancers - You are pregnant, breastfeeding, or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogenic Human Islet Cells

islet cells transplanted into the portal vein in the liver

DRUGGastrin 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.