A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes

Our previous work demonstrated that human cord blood-derived multipotent stem cells (CB-SCs)
are a unique type of stem cell identified from human cord blood, distinct from other stem
cell types including hematopoietic stem cells (HSCs), and mesenchymal stem cells (MSCs). The
stem cells and harnessed some of their unique properties with Stem Cell Educator therapy by
using CB-SCs in a closed-loop system that circulates a patient's blood through a blood cell
separator, briefly co-cultures the patient's lymphocytes with adherent CB-SCs in vitro, and
returns the "educated" lymphocytes (but not the CB-SCs) to the patient's circulation . This
treatment leads to global immune modulations and immune balance as demonstrated by clinical
data and animal studies. The Stem Cell Educator therapy may revolutionize the clinical
treatment of diabetes and other immune-related diseases through CB-SCs' immune education and
induction of immune balance, without the safety and ethical concerns associated with
conventional stem cell-based approaches

Inclusion Criteria:

- Adult patients
- Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes
Association criteria for the Clarification and Diagnosis of diabetes

- Must have a blood test confirming the presence of at least one autoantibody to
pancreatic islet cells (IAA, IA2, GAD 65, ZnT8)

- Fasting C-peptide level > 0.3 ng/ml

- Adequate venous access for apheresis

- Ability to provide informed consent

- 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.

- 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

- Pregnancy or breastfeeding mothers

- 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 (lupus, rheumatoid arthritis, scleroderma,
etc.)

- Anticoagulation other than ASA.

- Hemoglobin < 10 g/dl or platelets < 100 k/ml

- Is unable or unwilling to provide informed consent

- Presence of any other physical or psychological medical condition that, in the opinion
of the investigator, would preclude participation