Status:
COMPLETED
PolyTreg Immunotherapy in Islet Transplantation
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Diabetes Research Institute Foundation
Liana's Dream Foundation
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-68 years
Phase:
PHASE1
Brief Summary
Islet transplantation is a relatively new procedure used in people with difficult to control Type 1 diabetes. Patients who receive an islet transplant take medication that suppresses their immune syst...
Detailed Description
BACKGROUND: Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by the destruction of pancreatic beta (β)-cells, resulting in absolute deficiency of insulin. To date, clinical isle...
Eligibility Criteria
Inclusion
- To be eligible, subjects must be 18-68 years old, and have had T1DM for more than 5 years, complicated by at least 1 of the following situations that persist despite intensive insulin management efforts:
- Reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at plasma glucose levels \< 3.0 mmol/L, indicated by, 1 or more episodes of severe hypoglycemia requiring third party assistance within 12 months, or a Clarke score ≥4, or HYPO score ≥1000, or lability index (LI) ≥400 or combined HYPO/LI \>400/\>300.
- Metabolic instability, characterized by erratic blood glucose levels that interfere with daily activities and or 1 or more hospital visits for diabetic ketoacidosis over the last 12 months.
- In addition, participants must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
Exclusion
- Patients will be excluded if they meet any one or more of the following criteria:
- Severe co-existing cardiac disease, characterized by any one of these conditions: (a) recent myocardial infarction (within past 6 months); (b) left ventricular ejection fraction \<30%; or (c) evidence of ischemia on functional cardiac exam
- Active alcohol or substance abuse (must be abstinent for 6 months prior to transplant)
- Clinical history of T1DM diagnosed \>age 40, insulin dependent \<5 years
- Active infection including Hepatitis C, Hepatitis B, HIV, tuberculosis (TB) (subjects with a positive purified protein derivative (PPD) performed within one year of enrolment, and no history of adequate chemoprophylaxis)
- Measured glomerular filtration rate (GFR) \< 60mL/min/1.73 m2
- Presence or history of macroalbuminuria (\>300 mg/g creatinine)
- Clinical suspicion of nephritic (hematuria, active urinary sediment) or rapidly progressing renal impairment (e.g. Increase in serum creatinine of 25% within the last 3-6 months)
- Baseline Hb \< 105g/L (\<10.5 g/dL) in women, or \< 120 g/L (\<12 g/dL) in men
- Untreated proliferative retinopathy
- Positive pregnancy test, intent for future pregnancy, failure to follow effective contraceptive measures, or presently breast-feeding
- Previous transplant or evidence of significant sensitization on panel reactive antibody (PRA) (at the discretion of the investigator).
- Insulin requirement \>1.0 U/kg/day
- HbA1C \>12%
- Uncontrolled hyperlipidemia \[fasting LDL cholesterol \> 3.4 mmol/L (133 mg/dL), treated or untreated; and/or fasting triglycerides \> 2.3 mmol/L (90 mg/dL)\]
- 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 Celiac disease
- Patients with a Graves disease will be excluded unless previously adequately treated with radioiodine ablative therapy
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03444064
Start Date
February 1 2018
End Date
December 17 2024
Last Update
December 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8