Type 1 diabetes
Conditions
Brief summary
Safety Safety parameters will be evaluated in the intervention trial at each study visit and recorded as adverse events (AEs). Any grade 3 event (or higher) will be evaluated by DSMB. Efficacy Change in C-peptide Area Under the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at 12 months following WJMSC/Placebo infusion when compared to test performed before the start of treatment (baseline).
Detailed description
The proportion of study participants independent of insulin (ADA criteria) at 6 and 12 months., The proportion of participants with daily insulin needs <0.25U/kg at 6 and 12 months., Insulin requirement/kg body weight at 6 and 12 months., Glycosylated Hb (HbA1c) and insulin-dose adjusted HbA1c (IDAA1c) at 6 and 12 months., · Time-in-target (4-8 mmol/l) and Time-in-range (3.9-10 mmol/l) as measured by flash glucose monitoring for 14 days at 6 and 12 months., · Change in C-peptide Area Under the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at 6 months following WJMSC/Placebo infusion when compared to test performed before the start of treatment (baseline)., Change in peak C-peptide concentration during the first 6 months or the first year after treatment
Interventions
DRUGProTrans
Sponsors
Region Uppsala
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Safety parameters will be evaluated in the intervention trial at each study visit and recorded as adverse events (AEs). Any grade 3 event (or higher) will be evaluated by DSMB. Efficacy Change in C-peptide Area Under the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at 12 months following WJMSC/Placebo infusion when compared to test performed before the start of treatment (baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of study participants independent of insulin (ADA criteria) at 6 and 12 months., The proportion of participants with daily insulin needs <0.25U/kg at 6 and 12 months., Insulin requirement/kg body weight at 6 and 12 months., Glycosylated Hb (HbA1c) and insulin-dose adjusted HbA1c (IDAA1c) at 6 and 12 months., · Time-in-target (4-8 mmol/l) and Time-in-range (3.9-10 mmol/l) as measured by flash glucose monitoring for 14 days at 6 and 12 months., · Change in C-peptide Area Under the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at 6 months following WJMSC/Placebo infusion when compared to test performed before the start of treatment (baseline)., Change in peak C-peptide concentration during the first 6 months or the first year after treatment | — |
Countries
Sweden
Outcome results
None listed