No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 68
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
City of Hope Medical Center · Other
Who this trial is looking for
This trial is looking for adults with hard-to-control type 1 diabetes to see if Gastrin treatment can help improve insulin production. Participants will undergo islet transplantation and follow a specific care plan afterward.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 68 years old.
I have been diagnosed with type 1 diabetes for at least 5 years.
I have experienced frequent low blood sugar episodes.
I am willing to follow a strict post-transplant care plan.
I can give informed consent.
I am fully vaccinated against COVID-19.
You may not be able to join if
My body mass index (BMI) is over 33.
I need more than 1.0 units of insulin per kilogram of body weight each day.
I have significant kidney disease.
I have serious liver problems.
I have significant heart disease.
I have a current serious infection.
I have a history of certain types of cancer.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 allogen…
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
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. Age 18-68 years
2. 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.
3. Unstable blood glucose characterized by:
Frequent hypoglycemia (blood glu…
Inclusion Criteria:
1. Age 18-68 years
2. 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.
3. 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
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
Exclusion Criteria:
1. BMI \> 33
2. Insulin requirements \> 1.0 units/kg/day
3. Significant kidney disease (estimated GFR from serum creatinine measurement \<65 ml/min, random spot urine microalbumin to creatinine ratio \>300mg albumin/g creatinine)
4. 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)
5. 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,
6. Evidence of active proliferative retinopathy
7. Hypertension( \>/= 140/90) despite appropriate treatment
8. Hyperlipidemia (total cholesterol \> 260 mg/dl, LDL \> 160 mg/dl, and/or triglycerides \> 300 mg/dl) despite appropriate treatment
9. Anemia (Hgb \< 11 g/dl) or other hematologic disorders that require medical attention
10. WBC \<3,000/ul
11. 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)
12. 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)
13. EBV IgG negative
14. Any history of malignancy, except completely resected squamous or basal cell skin cancer or in situ cancer of the cervix
15. Evidence of active peptic ulcer disease
16. History of gastric bypass
17. Recent history of non-adherence to recommended medical therapy
18. Psychiatric illness that is untreated, or likely to interfere significantly with study compliance despite treatment
19. Previous organ/tissue transplant
20. Administration of live attenuated vaccines within 60 days of enrollment.
21. Presence of a chronic disease that must be chronically treated with contraindicated medications
22. Use of investigational agents within four weeks of enrollment
23. Active alcohol or substance abuse, including cigarette smoking (must be abstinent for \> 3 months)
24. 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.
25. Individuals without health insurance covering the cost of immunosuppression and clinical and laboratory follow-up after completion of the study
26. Any medical condition that in the opinion of the investigator will interfere with safe participation in the trial
Contacts
Arthur Riggs Diabetes & Metabolism Research Institute at COH
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