Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes
Improving Islet Transplantation Outcomes With Gastrin
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 68 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 30 days, 1 year
- Procedures mentioned: Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "Participants will need to return to City of Hope in Duarte, CA for frequent follow-up visits for one year after transplant."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding gastrin, a gut hormone, to a transplant of insulin-making cells is safe and helps control blood sugar. It is for adults with hard-to-control type 1 diabetes and uses cells from a deceased, unrelated donor. Both the donor cells and gastrin treatment are experimental and are not FDA-approved to treat any disease.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18–68 years old.
- You have had type 1 diabetes for at least 5 years. Blood tests must show that your body makes very little insulin.
- You have unstable blood sugar. This may mean blood sugar of 54 mg/dl or lower more than once a week, trouble noticing low blood sugar, or blood sugar swings that disrupt daily life. You may also qualify if, in the past year, you had a severe low blood sugar episode or a hospital visit for diabetic ketoacidosis, a dangerous acid buildup.
- You can and will follow the transplant care plan, including taking medicines that keep your body from rejecting the cells and using reliable birth control.
- You can attend frequent visits, have tests, keep detailed blood sugar and medicine records, and complete follow-up studies.
- You can understand the study and agree to take part.
- You are fully vaccinated against COVID-19.
Who can't join
- Your BMI, a measure of weight compared with height, is over 33, or you need more than 1 unit of insulin per kilogram of body weight each day.
- You have serious kidney, liver, gallbladder, heart, or blood vessel disease; active diabetes-related damage involving new blood vessels in the eye; or blood pressure or blood fats that stay above study limits despite treatment.
- You have anemia (too few healthy red blood cells), low white blood cells, a blood disorder needing care, or a high risk of bleeding. Long-term use of blood thinners also rules you out.
- You have a recent infection that has not cleared, except a mild skin or nail fungal infection, or a long-term infection. You also cannot join if a blood test shows no past exposure to Epstein-Barr virus, or if you have a history of cancer, except certain fully removed skin or early cervical cancers.
- You have an active stomach or upper gut ulcer, have had gastric bypass surgery, or have had an organ or tissue transplant. You also cannot join if you received a live, weakened vaccine within 60 days or used an experimental drug within 4 weeks before joining.
- You recently did not follow medical treatment, have a mental illness that is untreated or would greatly affect study participation, or have active alcohol or drug misuse. Cigarette smoking also rules you out; you must have stopped for more than 3 months.
- You are pregnant, plan a future pregnancy, or are breastfeeding. If you can become pregnant, you must use effective birth control during study treatment and for as long as you take medicines to prevent transplant rejection.
- You need ongoing medicines that are not allowed, lack insurance for rejection-prevention medicines and follow-up care after the study, or have another condition the study doctor thinks would make participation unsafe.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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
Study sites (1)
CA
- City of Hope Medical Center · Duarte, CA 91010Fouad Kandeel, MD, PhD · Principal investigatorMore trials in Duarte