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New treatment option for Diabetes Mellitus, Type 1
Official title Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes
ClinicalTrials.gov ID: NCT03746769
What this study is testing
What is Allogenic Human Islet Cells?
Allogenic Human Islet Cells is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for diabetes mellitus, type 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 68
You may be able to join if
- Age 18-68 years
- 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...
- Unstable blood glucose characterized by: Frequent hypoglycemia (blood glucose less than or equal to 54 mg/dl more than once per week) -and/or-...
- Ability and willingness to comply with post-transplant regimen, including immunosuppression, use of reliable contraception, frequent clinic visits...
- Ability to give informed consent.
You likely can't join if
- BMI \> 33
- Insulin requirements \> 1.0 units/kg/day
- Significant kidney disease (estimated GFR from serum creatinine measurement \ 300mg albumin/g creatinine)
- Significant hepatobiliary disease, including elevation of liver enzymes \> twice the upper limit of normal for each of ALT and AST (any elevation of...
- Significant cardiovascular disease, including non-correctable coronary artery disease with ejection fraction \< 50% and/or recent myocardial...
- Evidence of active proliferative retinopathy
See the full eligibility criteria
- Age 18-68 years
- 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.
- 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...
- 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...
- Ability to give informed consent.
- Fully vaccinated against COVID-19
- BMI \> 33
- Insulin requirements \> 1.0 units/kg/day
- Significant kidney disease (estimated GFR from serum creatinine measurement \ 300mg albumin/g creatinine)
- 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...
- 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...
- Evidence of active proliferative retinopathy
- Hypertension( \>/= 140/90) despite appropriate treatment
- Hyperlipidemia (total cholesterol \> 260 mg/dl, LDL \> 160 mg/dl, and/or triglycerides \> 300 mg/dl) despite appropriate treatment
- Anemia (Hgb \< 11 g/dl) or other hematologic disorders that require medical attention
- WBC \<3,000/ul
- Increased risk of bleeding (platelet count \ 1.5), other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy (i.e. heparin or warfarin)
- 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)
- EBV IgG negative
- Any history of malignancy, except completely resected squamous or basal cell skin cancer or in situ cancer of the cervix
- Evidence of active peptic ulcer disease
- History of gastric bypass
- Recent history of non-adherence to recommended medical therapy
- Psychiatric illness that is untreated, or likely to interfere significantly with study compliance despite treatment
- Previous organ/tissue transplant
- Administration of live attenuated vaccines within 60 days of enrollment.
- Presence of a chronic disease that must be chronically treated with contraindicated medications
- Use of investigational agents within four weeks of enrollment
- Active alcohol or substance abuse, including cigarette smoking (must be abstinent for \> 3 months)
- 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...
- Individuals without health insurance covering the cost of immunosuppression and clinical and laboratory follow-up after completion of the study
- Any medical condition that in the opinion of the investigator will interfere with safe participation in the trial
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 68 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.