NCT03746769

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
27mo left

Started Jul 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jul 2019Aug 2028

First Submitted

Initial submission to the registry

November 9, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

July 7, 2019

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

9.1 years

First QC Date

November 9, 2018

Last Update Submit

February 20, 2026

Conditions

Diabetes Mellitus, Type 1

Keywords

isletislet celltransplantgastrinhypoglycemialabile diabetes

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who are insulin independent, free from severe hypoglycemia and have HbA1c less than or equal to 6.5% ("complete response")

    1 year post transplant (6 months after second course of Gastrin)

Secondary Outcomes (1)

  • Proportion of subjects who are free of severe hypoglycemic episodes (SHE) and have a HbA1c less than or equal to 7.0% ("partial response").

    At Month 1, Month 2.5, and Month 6 post start of each Gastrin course

Other Outcomes (12)

  • Reduction/elimination of hypoglycemia

    At Month 1, Month 2.5, and Month 6 post start of each Gastrin course

  • Reduction in daily insulin use

    At Month 1, Month 2.5, and Month 6 post start of each Gastrin course

  • Reduction of daily insulin use per 100,000 IEQ transplanted

    At Month 1, Month 2.5, and Month 6 post start of each Gastrin course

  • +9 more other outcomes

Study Arms (1)

Single Arm Study

EXPERIMENTAL
Biological: Allogenic Human Islet CellsDrug: Gastrin 17

Interventions

Allogenic Human Islet CellsBIOLOGICAL

islet cells transplanted into the portal vein in the liver

Single Arm Study
Gastrin 17DRUG

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.

Single Arm Study

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-68 years
  • Type 1 diabetes mellitus (documented with fasting C-peptide level of \</= 0.2 ng/ml before and \</= 0.3 ng/ml after IV administration of 1 mg of glucagon) for at least 5 years.
  • Unstable blood glucose characterized by:
  • Frequent hypoglycemia (blood glucose less than or equal to 54 mg/dl more than once per week)
  • and/or- Hypoglycemia unawareness (Clarke score of 4 or more).
  • and/or- One or more severe hypoglycemic episodes in 12 months preceding enrollment
  • and/or- Erratic blood glucose levels that interfere with daily activities
  • and/or- One or more hospital visits for diabetic ketoacidosis in the 12 months preceding enrollment
  • Ability and willingness to comply with post-transplant regimen, including immunosuppression, use of reliable contraception, frequent clinic visits, testing and maintaining detailed logs of blood glucose levels, insulin doses and medications, and completing detailed follow-up studies.
  • Ability to give informed consent.
  • Fully vaccinated against COVID-19

You may not qualify if:

  • BMI \> 33
  • Insulin requirements \> 1.0 units/kg/day
  • Significant kidney disease (estimated GFR from serum creatinine measurement \<65 ml/min, random spot urine microalbumin to creatinine ratio \>300mg albumin/g creatinine)
  • Significant hepatobiliary disease, including elevation of liver enzymes \> twice the upper limit of normal for each of ALT and AST (any elevation of these enzymes will be determined), bilirubin not within normal limits, albumin \< 3.5 g/dl, liver masses, portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e. gallstones)
  • Significant cardiovascular disease, including non-correctable coronary artery disease with ejection fraction \< 50% and/or recent myocardial infarction (within last 12 months); or extensive peripheral vascular disease not correctable by surgery,
  • Evidence of active proliferative retinopathy
  • Hypertension( \>/= 140/90) despite appropriate treatment
  • Hyperlipidemia (total cholesterol \> 260 mg/dl, LDL \> 160 mg/dl, and/or triglycerides \> 300 mg/dl) despite appropriate treatment
  • Anemia (Hgb \< 11 g/dl) or other hematologic disorders that require medical attention
  • WBC \<3,000/ul
  • Increased risk of bleeding (platelet count \< 120,000 cells/ul; INR \> 1.5), other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy (i.e. heparin or warfarin)
  • Recent unresolved acute infection (except for mild skin infection or nail fungal infection), or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or syphilis (RPR)
  • EBV IgG negative
  • Any history of malignancy, except completely resected squamous or basal cell skin cancer or in situ cancer of the cervix
  • Evidence of active peptic ulcer disease
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Interventions

gastrin 17

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Fouad Kandeel, MD, PhD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur Riggs Diabetes & Metabolism Research Institute at COH

CONTACT

1-866-44-ISLET(1-866-444-7538)Islets@coh.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 20, 2018

Study Start

July 7, 2019

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations

US(1)