Type 1 diabetes MedDRA version: 20.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861
Conditions
Interventions
Product Name: ProTrans
Pharmaceutical Form: Suspension for injection
Sponsors
NextCell Pharma
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. A new written informed consent for participation of the study is required to be given before undergoing any study-specific procedures. 2. Only patients that have previously been dosed by the IMP according to protocol Protrans-1 are eligible for a second dose of Protrans. 3. No identified IMP related on-going adverse event, neither history of any adverse event that is evaluated potentially to be related to the previous IMP dosing in Protrans I. 4. Clinical history compatible with type 1 diabetes diagnosed less than 3 years before enrolment. This also includes control patients not receiving IMP. 5. Only male patients between 18-41 years of age will be included. 6. Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to provide informed consent 2. Patients with body mass index (BMI) > 30, or weight >100 kg 3. Patients with weight 30, or weight >100 kg 3. Patients with weight <50 kg 4. Patients with unstable cardiovascular status incl. NYHA class III/IV or symptoms of angina pectoris. 5. Patients with uncontrolled hypertension (=160/105 mmHg). 6. Patients with active infections unless treatment is not judged necessary by the investigators 7. Patients with latent or previous as well as on-going therapy against tuberculosis, or exposed to tuberculosis or has travelled in areas with high risk of tuberculosis or mycosis within the last 3 months. 8. Patients with serological evidence of infection with HIV, Treponema pallidum, hepatitis B antigen (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C. 9. Patients with any immune suppressive treatment 10. Patients with known demyelinating disease or with symptoms or physical examination findings consistent with possible demyelinating disease. 11. Patients with known, or previous, malignancy. 12. Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin 13. Patients with GFR <80 ml/min/1.73 m2 body surface 14. Patients with proliferative retinopathy 15. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC. 16. Known hypersensitivity against any excipients, i.e. dimethyl sulfoxide (DMSO).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective To investigate the safety and tolerance after a repeated allogeneic infusion of WJMSCs intravenously in adult patients diagnosed with type 1 diabetes after one year following the repeated treatment. Safety Objective To investigate the safety and tolerance after a repeated allogeneic infusion of WJMSCs intravenously in adult patients diagnosed with type 1 diabetes after 5 year following the repeated treatment.;Secondary Objective: Secondary Objectives Study changes in beta-cell function, metabolic control and Diabetes Treatment Satisfaction during one year following the repeated treatment.;Primary end point(s): Primary Endpoint The primary endpoint in this study is; safety parameters include adverse events and hypoglycemia, allergic reactions, ophthalmologic examination, ECG, vital signs, laboratory assessments at day 372. Safety Endpoint The safety endpoint of this study is the safety and tolerance after a repeated allogeneic infusion of WJMSCs intravenously in adult patients diagnosed with type 1 diabetes after 5 year.;Timepoint(s) of evaluation of this end point: Primary Endpoint: At day 372 Safety Endpoint During the whole trial 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoint: Delta-change of C-peptide Area Under 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. • Number of patients insulin independent (ADA criteria) at day 372. • Number of patients with daily insulin needs 0.20 nmol/l, in response to the MMTT, at day 372. • To study changes during one year following treatment in: -Insulin doses -HbA1c -Glucose variability -Diabetes Treatment Satisfaction;Timepoint(s) of evaluation of this end point: Secondary endpoints: Day 372 following WJMSC | — |
Countries
Sweden
Contacts
Public ContactMathias Svahn
NextCell Pharma
Outcome results
None listed