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

Prior treatment

• 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 known, or previous, malignancy.
• Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC.

Other illness

• 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 known demyelinating disease or with symptoms or physical examination findings consistent with possible demyelinating disease.
• Known hypersensitivity against any excipients, i.e. dimethyl sulfoxide (DMSO).- This criterion is only applicable to patients which receive study drug.

Lab values

• 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

Other

• Inability to provide informed consent
• Patients with body mass index (BMI) \> 30, or weight \>100 kg
• Patients with weight \<50 kg
• Patients with any immune suppressive treatment
• Patients with proliferative retinopathy

• 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.