This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Hospital for Sick Children
Toronto, Ontario, Canada
RECRUITINGStage A Safety: Side effects reported for entire cohort
To determine if there are unexpected adverse events with intra arterial delivery of sP into the celiac artery in individuals with Type 1 Diabetes, and evidence of residual beta cell function as reflected by a peak C---peptide levels of \> 200 pmol/L. Multiple measurements per patient will be aggregated to arrive at one reported value: Number of participants with abnormal laboratory values, adverse events and/or peak C-peptide levels \>200pmol/L that are related to treatment.
Time frame: Reported during the first 20-27 days following sP administration
C-Peptide Levels (small cohort)
To determine in an initial small cohort (n=12, toxicity and dose finding cohort) if one or more sP doses significantly increases the basal or stimulated c---Peptide levels at Day 20---27 post---injection using data from Mixed Meal Tolerance Test (MMTT).
Time frame: Day 20-27 post sP injection
C-Peptide Levels (large cohort)
To assess in a larger cohort (n=40, continued safety and efficacy) whether sP dose, determined from the dose finding cohort, significantly increases basal or stimulated C-- peptide levels at Day 20---27 post sP---injection using MMTT data.
Time frame: Day 20-27 post sP injection
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