Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

Inclusion Criteria

• Pediatric and adult patients (>10 years).
• Must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) Guidelines.
• Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet beta Cells (IAA, IA2, GAD 65, ZnT8).
• Fasting C-peptide level > 0.3 ng/ml.
• Adequate venous access for apheresis.
• Ability to provide informed consent or assent.
• For female patients only, willingness to use FDA-recommended birth control (http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356451.pdf) until 6 months post treatment.
• Must agree to comply with all study requirements and be willing to complete all study visits.

Exclusion Criteria

• AST or ALT 2 > x upper limit of normal.
• Abnormal bilirubin (total bilirubin > 1.2 mg/dL, direct bilirubin > 0.4 mg/dL).
• Creatinine > 2.0 mg/dl.
• Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.
• Known active infection such as Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV), HTLV (human T-cell leukemia-lymphoma virus cAB), or active tuberculosis.
• Pregnant or breastfeeding women.
• Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
• Presence of any other autoimmune diseases (Hashimoto's thyroiditis, celiac disease, lupus, rheumatoid arthritis, scleroderma, etc.).
• Anticoagulation other than ASA.
• Hemoglobin \< 10 g/dl or platelets \< 100 k/ml.
• Subjects with leukopenia, total white blood cells (WBC) count \< 4000/uL.
• Patient or patient's surrogate is unable or unwilling to voluntarily sign an informed consent form.
• Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation.