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Diabetes Mellitus, Type 1Phase 1/2NCT03746769

Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes

A Phase 1/2 study testing Allogenic Human Islet Cells and Gastrin 17 in people with Diabetes Mellitus, Type 1, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 68 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Allogenic Human Islet Cells and Gastrin 17
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
29 May 2019to 1 Aug 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 68 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • -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

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • History of gastric bypass
  • Recent history of non-adherence to recommended medical therapy
  • Psychiatric illness that is untreated, or likely to interfere significantly with study compliance despite treatment
  • Previous organ/tissue transplant
  • Administration of live attenuated vaccines within 60 days of enrollment.
  • Presence of a chronic disease that must be chronically treated with contraindicated medications
  • Use of investigational agents within four weeks of enrollment
  • Active alcohol or substance abuse, including cigarette smoking (must be abstinent for > 3 months)
  • Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures (i.e., tubal ligation, two barrier methods, abstinence) for the duration of study treatment and for as long as they are on immunosuppressive medication, and women presently breastfeeding.
  • Individuals without health insurance covering the cost of immunosuppression and clinical and laboratory follow-up after completion of the study
  • Any medical condition that in the opinion of the investigator will interfere with safe participation in the trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Arthur Riggs Diabetes & Metabolism Research Institute at COH contact

1-866-44-ISLET(1-866-444-7538)

Islets@coh.org

United States1 site, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Fouad Kandeel, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: Improving Islet Transplantation Outcomes With Gastrin

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
Read the detailed description

Islet cell transplantation involves transplanting the cells that make insulin from a pancreas of deceased organ donor to a patient with diabetes. Because there is a limited supply of donor islet cells available, this study is testing whether Gastrin injections can help make a fewer number of transplanted islets work better.

Gastrin is a natural gut hormone that is present in the pancreas during its development in the embryo but not after birth, and is believed to participate in the formation of the normal pancreas. Several studies have tried to use gastrin to help grow insulin making islet cells in laboratory experiments or after transplanting islets in laboratory animals. In early clinical trials, diabetic patients treated with gastrin and other growth factors required less insulin after 4 weeks of gastrin treatment and the effect lasted more than 12 weeks after stopping treatment, suggesting that gastrin may have increased the number of cells that make insulin.

This study will evaluate whether taking Gastrin injections following a single islet transplantation is safe, improves how well the islet transplant works and/or helps increase the number of insulin-making cells in the islets.

Qualified participants will receive treatment with a single islet transplant and two rounds of gastrin treatment (twice daily injections for 30 days) with transplant and again 6 months later. Study participants will also take anti-rejection medications (to prevent the body from rejecting the islet cells) and other medications to guard against infection and support their health and/or the health of the transplanted islets. Participants will need to return to City of Hope in Duarte, CA for frequent follow-up visits for one year after transplant.

Being tested
Allogenic Human Islet Cells, Gastrin 17
Keywords
islet, islet cell, transplant, gastrin, hypoglycemia, labile diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogenic Human Islet CellsBiological

    islet cells transplanted into the portal vein in the liver

  • 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.

Study groups in NCT03746769
Study groupRoleWhat they receive
Single Arm StudyExperimentalNot described
Receives: Biological: Allogenic Human Islet Cells; Drug: Gastrin 17

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (1)

  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").

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2018
  2. Study start29 May 2019
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03746769
Sponsor's protocol ID
18156
Status last verified
Oct 2026
First submitted
9 Nov 2018
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Orr C, Stratton J, El-Shahawy M, Forouhar E, Peng A, Singh G, Omori K, Qi M, Kandeel F. Impact of Tacrolimus, Sirolimus, Age, and Body Mass Index on the Occurrence of Skin Cancer and Islet Dysfunction After Transplantation. Cell Transplant. 2025 Jan-Dec;34:9636897241309412. doi: 10.1177/09636897241309412.

    PubMed 39780302

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogenic Human Islet Cells and Gastrin 17 in people with Diabetes Mellitus, Type 1, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arthur Riggs Diabetes & Metabolism Research Institute at COH (1-866-44-ISLET(1-866-444-7538), Islets@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03746769, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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