Status:
WITHDRAWN
cePolyTregs in Islet Transplantation
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Juvenile Diabetes Research Foundation Canadian Clinical Trial Network
Conditions:
Diabetes type1
Eligibility:
All Genders
18-68 years
Phase:
PHASE1
Brief Summary
The transplant of the insulin-producing cell into the liver (Islet transplant) has been proven an effective and valuable treatment for type 1 diabetics patients with poor blood sugar. However, Islet t...
Detailed Description
Type-1 diabetes mellitus (T1DM) occurs due to a loss of insulin production caused by the destruction of the insulin producing cells located in the human pancreas. Patients living with T1DM experience ...
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, TB (subjects with a positive 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 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 :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05349591
Start Date
August 15 2022
End Date
May 22 2025
Last Update
June 17 2025
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7