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Cell Therapy
Gastrin + Islet Transplant for Type 1 Diabetes
Phase 1 & 2
Recruiting
Led By Fouad Kandeel, MD, PhD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-68 years
Type 1 diabetes mellitus for at least 5 years (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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 1, month 2.5, and month 6 post start of each gastrin course
Awards & highlights
Study Summary
This trial will evaluate if the combination of these two products can help patients with type 1 diabetes who have difficulty controlling their blood sugar levels with insulin make insulin again and improve blood sugar control.
Who is the study for?
This trial is for adults aged 18-68 with type 1 diabetes who have unstable blood glucose, frequent hypoglycemia, or severe episodes leading to hospital visits. Participants must be fully vaccinated against COVID-19 and willing to follow a strict post-transplant regimen including immunosuppression and contraception. Exclusions include active peptic ulcers, untreated psychiatric illness, significant cardiovascular disease, high insulin requirements, certain infections like HIV/HBV/HCV/CMV/syphilis, recent organ transplants, and those without insurance for follow-up care.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Gastrin hormone treatment combined with transplantation of human allogenic islet cells in patients with difficult-to-control type 1 diabetes. These experimental treatments aim to help patients produce their own insulin again and improve blood sugar control.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to the introduction of foreign cells (transplanted islets) such as inflammation or infection risks from immunosuppressive drugs required after transplant. Specific side effects of Gastrin are not detailed but could involve digestive system disturbances given its role in gut hormone secretion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 68 years old.
Select...
I have had Type 1 diabetes for over 5 years with specific C-peptide levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at month 1, month 2.5, and month 6 post start of each gastrin course
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 1, month 2.5, and month 6 post start of each gastrin course
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects who are insulin independent, free from severe hypoglycemia and have HbA1c less than or equal to 6.5% ("complete response")
Secondary outcome measures
Proportion of subjects who are free of severe hypoglycemic episodes (SHE) and have a HbA1c less than or equal to 7.0% ("partial response").
Other outcome measures
C-peptide/insulin secretion response to glucose/arginine stimulation and other metabolic studies.
Improvement in Personal Glycemic State (PGS) score calculated from continuous glucose monitoring
Improvement in glucose time in range during continuous glucose monitoring
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm StudyExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
571 Previous Clinical Trials
1,922,562 Total Patients Enrolled
University of California, Los AngelesOTHER
1,538 Previous Clinical Trials
10,267,010 Total Patients Enrolled
Fouad Kandeel, MD, PhDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an active stomach ulcer.You are actively abusing alcohol, drugs, or smoking cigarettes, unless you have been abstinent for more than 3 months.I have had an organ or tissue transplant.You do not have antibodies for the Epstein-Barr virus.I have anemia or another blood disorder needing treatment.I have not received any live vaccines in the last 60 days.I use more than 1 unit of insulin per kilogram of my body weight daily.Your blood sugar levels are not stable and you have frequent low blood sugar episodes, are unaware of low blood sugar symptoms, have had severe low blood sugar episodes in the past year, or have erratic blood sugar levels that affect your daily life.I am between 18 and 68 years old.I am committed to following a strict post-transplant care plan, including medication adherence and health monitoring.You have a body mass index (BMI) higher than 33.I have had Type 1 diabetes for over 5 years with specific C-peptide levels.I have a high risk of bleeding or am on long-term blood thinners.I am on long-term medication for a chronic illness that cannot be used with the trial drugs.My blood pressure is high (140/90 or more) despite taking medication.My kidney function is low, and I have high levels of protein in my urine.I have an eye condition where new blood vessels are growing abnormally.You have a mental illness that is not being treated, or even with treatment, it may make it hard for you to follow the study rules.I am not pregnant, not planning to become pregnant, and willing to use effective birth control if of childbearing potential.I do not have serious heart or blood vessel diseases that can't be fixed with surgery.I have had cancer before, but it was either skin cancer that was completely removed or a non-invasive cervical cancer.My cholesterol or triglycerides are high despite treatment.Your white blood cell count is less than 3,000 per microliter.I do not have any current severe infections or long-term infections like TB, HIV, or hepatitis.I have not followed my doctor's advice on treatment recently.My health insurance does not cover post-study care costs.I have had a gastric bypass surgery.My liver function tests are not normal, or I have serious liver or gallbladder issues.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm Study
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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