An open label, parallel single centre trial of Wharton's Jelly derived allogenic mesenchymal stromal cells repeated treatment to preserve endogenous insulin production in adult patients diagnosed with type 1 diabetes
This is a phase (I)/II study, and the purpose of this study is to determine whether, in adult patients diagnosed for type 1 diabetes, a repeated allogeneic infusion of WJMSCs is safe and to study changes in beta-cell function, metabolic control and Diabetes Treatment Satisfaction. The study population will consist of 15 adult male patients, 18-41 years of age (inclusive at both ends) diagnosed (\<3,5 years) with type 1 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Karolinska Trial Alliance, Fas 1 enheten, Karolinska Universitetssjukhuset Huddinge
Huddinge, Sweden
The primary endpoint in this study is; safety parameters include adverse events and hypoglycemia, allergic reactions, ophthalmologic examination, ECG, vital signs, laboratory assessments.
To investigate the safety and tolerance after a repeated allogeneic infusion of Whartons Jelly Mesenchymal Stromal Cells (WJMSCs) intravenously in adult patients diagnosed with type 1 diabetes after one year following the repeated treatment.
Time frame: 372 days
Delta-change of C-peptide AreaUnder the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at day 372 following WJMSC infusion when compared to test performed before start of treatment when compared to control patients.
To study changes in insulin requirements during one year following treatment .
Time frame: 372 days
Number of patients insulin independent (ADA criteria) at day 372.
To study changes in insulin requirements during one year following treatment .
Time frame: 372 days
Number of patients with daily insulin needs <0.25U/kg at day 372.
To study changes in insulin requirements during one year following treatment .
Time frame: 372 days
Insulin requirement/kg BW at day 372. HbA1c at day 372.
To study changes in insulin requirements during one year following treatment .
Time frame: 372 days
HbA1c at day 372
To study changes in HbA1c during one year following treatment.
Time frame: 372 days
Glucose variability (mean amplitude of glycaemic excursions and glycaemic lability index) duration derived from the continuous glucose monitoring system® at day 372
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To study changes in glucose levels during one year following treatment.
Time frame: 372 days
Delta change of levels of fasting C-peptide at day 372 when compared to test before start of treatment
To study changes in fasting C-peptide levels during one year following treatment.
Time frame: 372 days
Numbers of patients with peak C-peptide >0.20 nmol/l, in response to the MMTT, at day 372.
To study changes in C-peptide levels during one year following treatment.
Time frame: 372 days
To study changes during one year following treatment in: -Insulin doses -HbA1c -Glucose variability -Diabetes Treatment Satisfaction
To study changes in C-peptide levels during one year following treatment.
Time frame: 372 days
To study changes in insulin requirements during one year following treatment
2\. Delta-change of C-peptide AreaUnder the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at day 372 following WJMSC infusion when compared to test performed before start of treatment when compared to control patients. Description:
Time frame: 372 days