Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

Inclusion Criteria:

1. Pediatric and adult patients (\>10 years).
2. Must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) Guidelines.
3. Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet beta Cells (IAA, IA2, GAD 65, ZnT8).
4. Fasting C-peptide level \> 0.3 ng/ml.
5. Adequate venous access for apheresis.
6. Ability to provide informed consent or assent.
7. 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.
8. Must agree to comply with all study requirements and be willing to complete all study visits.

Exclusion Criteria:

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