Islet cell transplant aims to free diabetics from insulin shots
NCT ID NCT00160732
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if transplanting donor islet cells into the liver can safely help people with difficult-to-control type 1 diabetes achieve normal blood sugar levels without insulin. Up to 50 adults aged 18-58 who have had diabetes for at least 5 years and still struggle with blood sugar swings despite intensive insulin therapy will receive the cells along with anti-rejection drugs. The goal is to reduce or eliminate the need for insulin injections, but lifelong immunosuppression is required.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2003
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 58 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 means, or, by the investigators' evaluation, symptoms and/or signs of liver dysfunction with or without portal hypertension including, but not limited to, jaundice, ascites, encephalopathy, spider angiomata, coagulopathy, or peri-umbilical venous engorgement. Elevated portal pressures, as measured during intended islet infusion, may also result in discontinuation of infusion. * Abnormal liver function tests (\> 2 times the upper limit of normal as defined by the University of Chicago Clinical Laboratory) * History of malignancy. Any history of malignancy in a patient who has had an "adequate" period of no evidence of neoplastic disease should not rule out individuals from enrolling in this study. Rather, pre-enrollment screening for malignancy will follow current established guidelines as for solid-organ transplant. These current guidelines appear in Kasiske, B.L., et al. "The Evaluation of Renal Transplant Candidates: Clinical Practice Guidelines," American Journal of Transplantation 1 (Supplement 2): 12-22, 2001. * Active peptic ulcer disease * Pregnancy, or inability to comply with contraceptive regimen * Severe unremitting gastroparesis or diarrhea * Active infection * Serologic positivity for HIV and/or hepatitis * Chest radiographic abnormality consistent with neoplastic or infectious disease * Major ongoing psychiatric illness and/or substance abuse * Noncompliance with current medical regimen * Obesity (body mass index \[BMI\] \> 28) * Any other medical condition precluding safe transplantation and immunosuppression * Ejection fraction \< 30% * Myocardial infarction (MI) within the past 6 months * Known allergies or hypersensitivity to immunosuppressive agents used in this protocol * Inability to provide written informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The University of Chicago Hospitals
Chicago, Illinois, 60637, United States
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Other studies related to the condition(s) this trial covers.
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