Wharton´s Jelly Derived Mesenchymal Stromal Cell Repeated Treatment of Adult Patients Diagnosed with Type I 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.

Inclusion criteria

• A new written informed consent for participation of the study is required to be given before undergoing any study-specific procedures.
• Only patients that have previously been dosed by the IMP according to protocol Protrans-1 are eligible for a second dose of Protrans.
• 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.
• Clinical history compatible with type 1 diabetes diagnosed less than 3 years before enrolment. This also includes control patients not receiving IMP.
• Only male patients between 18-41 years of age will be included.
• Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol.

Exclusion criteria

• Inability to provide informed consent
• Patients with body mass index (BMI) > 30, or weight >100 kg
• Patients with weight <50 kg
• Patients with unstable cardiovascular status incl. NYHA class III/IV or symptoms of angina pectoris.
• Patients with uncontrolled hypertension (≥160/105 mmHg).
• Patients with active on-going infections.
• 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.
• 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.
• Patients with any immune suppressive treatment
• Patients with known demyelinating disease or with symptoms or physical examination findings consistent with possible demyelinating disease.
• Patients with known, or previous, malignancy.
• Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
• Patients with GFR <80 ml/min/1.73 m2 body surface
• Patients with proliferative retinopathy
• Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC.
• Known hypersensitivity against any excipients, i.e. dimethyl sulfoxide (DMSO).- This criterion is only applicable to patients which receive study drug.