Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03746769
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 68 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogenic Human Islet Cells — BIOLOGICAL
    islet cells transplanted into the portal vein in the liver
  • Gastrin 17 — DRUG
    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.

Study Details

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

Key Dates

Start date
Jul 7, 2019
Status verified
Feb 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm Study

Primary Outcome Measure

Proportion of subjects who are insulin independent, free from severe hypoglycemia and have HbA1c less than or equal to 6.5% ("complete response") [ Time Frame: 1 year post transplant (6 months after second course of Gastrin) ]

Central Contacts

  • Arthur Riggs Diabetes & Metabolism Research Institute at COH
    1-866-44-ISLET(1-866-444-7538)
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Fouad Kandeel, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
City of Hope Medical Center· Duarte, CA

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