cePolyTregs in Islet Transplantation (NCT05349591) | Clinical Trial Compass
WithdrawnPhase 1
cePolyTregs in Islet Transplantation
Stopped: Due to feasibility challenges and following mutual agreement by JDRF CCTN and the Principal Investigator for Statement of Work 4 (SOW4), the study conducted by Dr. James Shapiro has been withdrawn/terminated.
Canada0Started 2022-08-15
Plain-language 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 transplant is currently limited by the number of pancreas organ donors and the need for lifelong medication requirements such as antirejection drugs. The investigators have learned that Regulatory T cells (Tregs), a small subset of a cluster of differentiation 4+ (CD4+) T cells, have emerged as the major contributor to self-tolerance by preventing the initiation of unwanted immune activation and by suppressing ongoing immune responses to limit bystander tissue destruction. It has been suggested that infusion of Tregs before extensive graft damage may improve long-term graft outcomes. In this trial, we propose to study Analogous cryopreserved PolyTregs (cePolyTregs). cePolyTregs is a product with the same in vivo functionality to that of the non-cryopreserved PolyTregs.
Who can participate
Age range18 Years – 68 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion 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)
✕. 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