Phase 2 N=10 Treatment

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

Diabetes Mellitus, Type 1

Bottom Line

View on ClinicalTrials.gov: NCT00566813 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Nov 2018

Primary outcome: Primary: Number of Participants With Adverse Events Including Laboratory Abnormalities at the End of Study Participation — 4; 5 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Islet Cell Transplant (Drug); Islet Cell Transplant plus (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Illinois at Chicago
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events Including Laboratory Abnormalities at the End of Study Participation	4; 5	—
PRIMARY Number of Participants With Insulin Independence at End of Study Participation	4; 5	—
PRIMARY Number of Participants With HbA1c Less Than or Equal to 6.5 & Free of Severe Hypoglycemic Events	4; 5	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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 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 1.5 mg/dL
Macroalbuminuria > 300 mg/24h
Baseline Hb 20%)
Insulin requirement > 0.7 IU/kg/day
HbA1C > 12%
Hyperlipidemia
Chronic use of steroids
Use of coumadin or other anticoagulant (except aspirin) or PT INR > 1.5
Addison's disease
Allergy to radiographic contrast material

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00566813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.