Active — Not RecruitingPhase 1/2

Allogenic Islet Cell Transplantation

United States50 participantsStarted 2003-10

Plain-language summary

The purpose of this study is to determine the safety of transplanting human islet cells for controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In addition, initial observations will be made with regards to the effectiveness of reversing hypoglycemia with this treatment. The "Edmonton Protocol" of using specific anti-rejection drugs without steroids is also being evaluated.

Who can participate

Age range

18 Years – 58 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have type I diabetes mellitus, documented by undetectable C-peptide. Patients must have been diabetic for at least five years, and be aged 18 - 58 years. * Patients must be on an intensive regimen of glucose monitoring and exogenous insulin injection (defined as greater than or equal to three checks and injections per day). This regimen must be prescribed and supervised by the patient's diabetologist. * Despite intensive therapy, patients must have at least one of the following: * Brittle diabetes (metabolic instability), as defined by elevated mean amplitude of glycemic excursion; * Hypoglycemic unawareness, with at least one episode in the past two years in which hypoglycemia required the assistance of another person (e.g., family member, emergency medical technician \[EMT\], etc.), and was associated with a fingerstick blood glucose (FSBG) of \< 50 mg/dl and prompt recovery after administration of oral glucose, intravenous glucose, or glucagon; * Progressive complications of diabetes (nephropathy manifested by proteinuria, retinopathy documented by an ophthalmologist after dilated eye exam, or neuropathy as determined by a neurologist). * Patients must be able to give informed consent. Exclusion Criteria: * Failure to meet inclusion criteria * Panel of Reactive Antibody (PRA) \> 10% * Creatinine clearance \< 80 mL/min * Prior organ transplant * Portal hypertension: this refers to portal hypertension diagnosed previously by any …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

decrease in insulin requirement - Subjects able to maintain fasting blood glucose concentrations below 126 mg/dL and 2-hour post prandial levels below 180 mg/dL will be considered to be insulin independent.

Timeframe: Monthly

decrease in incidence of hypoglycemic events

Timeframe: Monthly

Trial details

NCT IDNCT00160732

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-10

View on ClinicalTrials.gov More Diabetes Mellitus, Type 1 trials