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Clinical Trial Details

Trial ID: L2054
Source ID: NCT03973827
Associated Drug: Protrans
Title: Wharton´s Jelly Derived Mesenchymal Stromal Cell Repeated Treatment of Adult Patients Diagnosed with Type I Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type1diabetes
Interventions: DRUG: ProTrans|OTHER: Control
Outcome Measures: Primary: 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., 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 ., 372 days | Secondary: Number of patients insulin independent (ADA criteria) at day 372., To study changes in insulin requirements during one year following treatment ., 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 ., 372 days|Insulin requirement/kg BW at day 372. HbA1c at day 372., To study changes in insulin requirements during one year following treatment ., 372 days|HbA1c at day 372, To study changes in HbA1c during one year following treatment., 372 days|Glucose variability (mean amplitude of glycaemic excursions and glycaemic lability index) duration derived from the continuous glucose monitoring system® at day 372, To study changes in glucose levels during one year following treatment., 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., 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., 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., 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:, 372 days
Sponsor/Collaborators: Sponsor: NextCell Pharma Ab
Gender: MALE
Age: ADULT
Phases: PHASE1|PHASE2
Enrollment: 15
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-05-17
Completion Date: 2024-11-20
Results First Posted:
Last Update Posted: 2025-03-07
Locations: Karolinska Trial Alliance, Fas 1 enheten, Karolinska Universitetssjukhuset Huddinge, Huddinge, Sweden
URL: https://clinicaltrials.gov/show/NCT03973827