Islet Transplantation Using Campath-1H and Infliximab Induction

Status:

COMPLETED

Islet Transplantation Using Campath-1H and Infliximab Induction

Lead Sponsor:

University of Alberta

Collaborating Sponsors:

Juvenile Diabetes Research Foundation

Conditions:

Type 1 Diabetes

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

Islet transplantation has been investigated as a treatment for Type 1 diabetes mellitus in selected patients with inadequate glucose control despite insulin therapy. However, the perennial hope that s...

Detailed Description

This is a single-centre, prospective, open-label study in Type 1 diabetic participants receiving an islet cell transplant; all participants will receive Campath-1H + Infliximab induction therapy follo...

Eligibility Criteria

Inclusion

must have Type 1 diabetes mellitus for more than 5 years
diabetes must be complicated by at least one of the following situations that persist despite intensive insulin management efforts. The complicating situations are (1) Reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at plasma glucose levels of \< 3.0 mmol/L; (2) Metabolic lability/instability, characterized by MAGE ≥ 11.0 mmol/L and wide swings in blood glucose despite optimal diabetes therapy; and (3) Despite efforts at optimal glucose control, progressive secondary complications of diabetes, including retinopathy, neuropathy, or nephropathy

Exclusion

Severe co-existing cardiac disease
Active alcohol or substance abuse
Psychiatric disorder making the subject not a suitable candidate for transplantation
Active infection including hepatitis C, hepatitis B, HIV, or TB
Any history of or current malignancies except squamous or basal skin cancer
BMI \> 28 kg/m2 or body weight \> 85 kg at screening visit
Positive fasting C-peptide response on assessment (2 positive results)
Creatinine clearance \< 80 mL/min/1.73 m2
Serum creatinine \> 150 µmol/L
Macroalbuminuria (urinary albumin excretion rate \> 300 mg/24h)
Baseline Hb \< 105g/L in women, or \< 130 g/L in men
Baseline LFT's outside of normal range
Untreated proliferative retinopathy
Positive pregnancy test, intent for future pregnancy or male subjects' intent to procreate, failure to follow effective contraceptive measures, or presently breast feeding
Previous transplant, or evidence of sensitization on PRA
Insulin requirement \> 1.0 IU/kg/day
HbA1C \> 0.12
Hyperlipidemia (fasting LDL cholesterol \> 3.4 mmol/L, treated or untreated; and/or fasting triglycerides \> 2.3 mmol/L)
Under treatment for a medical condition requiring chronic use of steroids
Use of coumadin or other anticoagulant therapy (except aspirin) or subject with PT INR \> 1.5
Untreated Addison's disease
Untreated Celiac disease
Untreated thyroid disease

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT00175266

Last Update

October 2 2009

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