RECRUITING Phase 3 ClinicalTrials.gov

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

Sponsor: Throne Biotechnologies Inc. • ClinicalTrials.gov ID: NCT04011020

Registry updated: 2026-10-05

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Description

Type 1 diabetes (T1D) is a T cell-mediated autoimmune disease that causes a deficit of pancreatic islet beta cells. Millions of individuals worldwide have T1D, and incidence increases annually. Several recent clinical trials point to the need for an approach that produces comprehensive immune modulation at both the local pancreatic and systemic levels. Stem Cell Educator (SCE) therapy offers comprehensive immune modulation at both the local and systemic levels in T1D by using a patient's own immune cells (including platelets) that are "educated" by cord blood stem cells. Tested clinically in more than 300 patients, SCE therapy has shown lasting reversal in autoimmunity in T1D patients, including improved C-peptide levels, reduced median glycated hemoglobin A1C (HbA1C) values, and decreased median daily usage of insulin. SCE therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent Cord Blood Stem Cells (CB-SC) in vitro, and returns the "educated" autologous immune cells to the patient's circulation.

Interventions

Stem Cell Educator therapy (Combination product)
Patients with T1D will be evaluated by the study principal investigator or sub-investigators. Informed consent will be obtained at the initial screen meeting. Subjects who meet all criteria will be scheduled for treatment. All enrolled subjects will receive treatment with the Stem Cell Educator (SCE) therapy consisting of a single session of mononuclear cells (MNC) collection by apheresis where peripheral blood will be processed on day 1. The MNC product will then be exposed overnight to the SCE and on day 2 the product Gleukocell will be infused intravenously back to the patient.

Eligibility criteria

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.

Conditions

Type 1 Diabetes

Locations

Throne Biotechnologies — Paramus, New Jersey, United States
Throne Biotechnologies — Paramus, New Jersey, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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