Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatments allogenic islet cells (human, u. chicago), intraportal infusion of islet cells
Phase phase 1/phase 2
Sponsor University of Chicago
Start date October 2003
End date October 2017
Trial size 50 participants
Trial identifier NCT00160732, 12176A, BB-IND 11228

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
allogenic islet cells (human, u. chicago)
Human allogenic islet cells. Immunosuppression varies but may include prograf, celcept, sirolimus, prednisone. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.
intraportal infusion of islet cells
Intraportal infusion of islet cell through the portal vein in the liver.

Primary Outcomes

Measure
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.
time frame: Monthly
decrease in incidence of hypoglycemic events
time frame: Monthly

Secondary Outcomes

Measure
absence of complications from the procedure and side effects of the medication
time frame: Monthly

Eligibility Criteria

Male or female participants from 18 years up to 58 years old.

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.

Additional Information

Official title Allogenic Islet Cells (Human, U. of Chicago) Administered Via Intraportal Infusion; and Immunosuppressive Therapy
Principal investigator Piotr Witkowski, MD, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Chicago.