Actively Recruiting
Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes
Led by City of Hope Medical Center · Updated on 2026-02-23
20
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
U
University of California, Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 68 years
- Diagnosed with type 1 diabetes mellitus for at least 5 years with specific C-peptide levels
- Unstable blood glucose with frequent hypoglycemia, hypoglycemia unawareness, severe hypoglycemic episodes, erratic blood glucose affecting daily life, or hospital visits for diabetic ketoacidosis in the past 12 months
- Ability and willingness to comply with post-transplant regimen including immunosuppression, contraception, clinic visits, and detailed health logs
- Ability to give informed consent
- Fully vaccinated against COVID-19
You will not qualify if you...
- Body Mass Index (BMI) greater than 33
- Insulin requirements over 1.0 units per kilogram per day
- Significant kidney disease with low estimated glomerular filtration rate or high urine albumin levels
- Significant liver or gallbladder disease including abnormal liver tests or liver masses
- Significant cardiovascular disease including poor heart function or recent heart attack
- Active proliferative retinopathy
- High blood pressure despite treatment
- High cholesterol or triglycerides despite treatment
- Anemia or other blood disorders needing medical attention
- Low white blood cell count
- Increased risk of bleeding or chronic blood clotting disorders
- Recent unresolved or chronic infections including tuberculosis, HIV, hepatitis, or syphilis
- Negative Epstein-Barr virus antibody test
- History of cancer except certain skin or cervical cancers fully treated
- Active peptic ulcer disease
- History of gastric bypass surgery
- Recent non-adherence to medical therapy
- Untreated or poorly controlled psychiatric illness
- Previous organ or tissue transplant
- Live vaccines within 60 days before enrollment
- Chronic diseases requiring contraindicated medications
- Use of investigational drugs within four weeks
- Active alcohol, substance abuse, or smoking within past 3 months
- Pregnant, breastfeeding, or unwilling/unable to use contraception during study and immunosuppression
- No health insurance for immunosuppression and follow-up care
- Any medical condition that may interfere with safe study participation according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
Research Team
A
Arthur Riggs Diabetes & Metabolism Research Institute at COH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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