Mesenchymal Stromal Cells to Treat Type 1 Diabetes in Children and Adolescents

Exclusion Criteria

• •1. Subjects with body weight \>100 kg
• •2. Subjects with unstable cardiovascular status incl. NYHA class III/IV or symptoms of angina pectoris.
• •3. Subjects with uncontrolled hypertension (≥160/105 mmHg).
• •4. Subjects with active on-going infections.
• •5. Subjects with latent or previous as well as on-going therapy against tuberculosis, or exposed to tuberculosis or has traveled in areas with a high risk of tuberculosis or mycosis within the last 3 months.
• •6. Subjects with serological evidence of infection with HIV, Treponema pallidum, hepatitis B antigen (subjects with serology consistent with previous vaccination and a history of vaccination are acceptable), or hepatitis C.
• •7. Subjects with any systemic immune suppressive treatment
• •8. Subjects with a known demyelinating disease or with symptoms or physical examination findings consistent with possible demyelinating disease.
• •9. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• •10. Subjects with known, or previous, malignancy.
• •11. Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin.
• •12. Subjects with GFR \<60 ml/min/1.73 m2 body surface.
• •13. Subject with any condition or any circumstance that, in the opinion of the investigator, would make it unsafe to undergo treatment with MSC.
• •14. Known hypersensitivity against any excipients, i.e., dimethyl sulfoxide (DMSO).