Islet Transplantation in Type 1 Diabetic Patients Using the Edmonton Protocol of Steroid Free Immunosuppression

Completed · Phase 1/Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

The primary purpose of this study is to demonstrate the safety of allogeneic islet transplantation in type 1 diabetic patients performed at the University of Illinois at Chicago (UIC). The purpose is to reproduce the Edmonton protocol to demonstrate that pancreatic islets isolated at UIC are safe and of sufficient quality to provide reproducible graft function.

Key facts

Study ID

NCT00566813

Run by

University of Illinois at Chicago

People needed

10

Starts

2004-11-01

Expected to finish

2020-07-15

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes > 5 years complicated by at least one of the following situations despite intensive insulin management:
• Reduced awareness of hypoglycemia at plasma glucose levels < 54 mg/dL
• Metabolic lability/instability characterized by two or more episodes of severe hypoglycemia or hospital visits for diabetic ketoacidosis over the last year
• Progressive secondary complications of diabetes:
• Retinopathy-three step progression using the ETDRS grading system or equivalent progression;
• Nephropathy- microalbuminuria rise of 50 µg/min (72 mg/24h) over three months within the past two years despite using an ACE inhibitor;
• Neuropathy-persistent gastroparesis, postural hypotension, neuropathic bowel or bladder, or severe peripheral neuropathy unresponsive to management

You may not qualify if…

• Co-existing cardiac disease:
• Myocardial infarction within past six months
• Angiographic evidence of non-correctable coronary artery disease
• Ischemia on functional cardiac exam d. Heart failure > NYHA II
• Active alcohol or substance abuse or cigarette smoking
• Psychiatric disorder: schizophrenia, bipolar disorder, or major depression that is unstable on medication
• Non-adherence to prescribed regimens
• Active infection including hepatitis C, hepatitis B, HIV
• TB by history, current infection, or under treatment for suspected TB
• History of malignancies except squamous or basal skin cancer
• Stroke within the past 6 months
• BMI > 26 kg/m2 or body weight > 70 kg at screening visit
• C-peptide response to glucagon stimulation, any C-peptide ≥ 0.3 ng/mL
• Inability to provide informed consent
• Age less than 18 or greater than 65 years
• Creatinine clearance < 85 mL/min/1.73 m2 by 24-hour urine collection
• Serum creatinine > 1.5 mg/dL
• Macroalbuminuria > 300 mg/24h
• Baseline Hb < 12 gm/dL in women, < 13 gm/dL in men
• Baseline liver function tests outside normal range
• Untreated proliferative retinopathy
• Positive pregnancy test, intent for pregnancy, male's intent to procreate, unwilling to use effective contraception, breast-feeding
• Previous transplant or PRA reactivity > 20%)
• Insulin requirement > 0.7 IU/kg/day
• HbA1C > 12%

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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