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Improving Islet Transplantation Outcomes With Gastrin for Type 1 Diabetes

This study is testing if Gastrin-17, a natural gut hormone, can improve the success of islet cell transplantation for people with difficult-to-control Type 1 diabetes. Islet cells, which make insulin, are transplanted into your liver from a deceased donor. You would also receive Gastrin-17 injections under the skin twice daily for 30 days, both soon after the transplant and again six months later. The goal is to see if this combination helps you make your own insulin, reduces severe low blood sugar (hypoglycemia), and improves your blood sugar control (HbA1c). This study is looking for 20 participants, aged 18-68, who have had Type 1 diabetes for at least 5 years and experience unstable blood sugar or hypoglycemia unawareness. The study's status is currently unclear.

Study design
This is an interventional study involving 20 participants. It is not specified if it is randomized, blinded, or what phase it is.
What's involved
Qualified participants will receive a single islet transplant and two rounds of Gastrin-17 treatment (twice daily injections for 30 days) with the transplant and again 6 months later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one year after the transplant, which is 6 months after the second course of Gastrin-17.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03746769

Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes

Recruiting
PHASE1Ages 18–68InterventionalTreatment
City of Hope Medical Center
~20 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:Allogenic Human Islet CellsGastrin 17

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects who are insulin independent, free from severe hypoglycemia and have HbA1c less than or equal to 6.5% ("complete response")
Measured over 1 year post transplant (6 months after second course of Gastrin)

Conditions

Diabetes Mellitus, Type 1

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
California1

Study leadership

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

Who to contact

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

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 4. 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. 5. Ability to give informed consent. 6. Fully vaccinated against COVID-19

What this trial measures

  • 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)