RECRUITING

Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes

Conditions

Diabetes Mellitus, Type 1 islet islet cell transplant gastrin hypoglycemia labile diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Improving Islet Transplantation Outcomes With Gastrin

Quick Facts

Study Start:2019-07-07

Study Completion:2026-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03746769

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 68 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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	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

Inclusion Criteria

Exclusion 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:
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

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 and Locations

Study Contact

Arthur Riggs Diabetes & Metabolism Research Institute at COH

CONTACT

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

Islets@coh.org

Principal Investigator

Fouad Kandeel, MD, PhD

PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center

Duarte, California, 91010

United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

Fouad Kandeel, MD, PhD, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-07

Study Completion Date2026-02-01

Study Record Updates

Study Start Date2019-07-07

Study Completion Date2026-02-01

Terms related to this study

Keywords Provided by Researchers

islet
islet cell
transplant
gastrin
hypoglycemia
labile diabetes

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 1