Type 1 Diabetes Clinical Trial
Official title:
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
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 200 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-SCs) in vitro, and returns the "educated" autologous immune cells to the patient's circulation.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 20, 2025 |
Est. primary completion date | October 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: 1. Adult patients ( 14 years) 2. Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes Association criteria for the Clarification and Diagnosis of diabetes. 3. Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet Cells (IAA, IA2, GAD 65, ZnT8). 4. Fasting C-peptide level > 0.3 ng/ml 5. HbA1C < 10% at enrollment 6. Recent diagnosis (within two years of enrollment) 7. Adequate venous access for apheresis 8. Must be equipped with a continuous glucose monitoring system (CGMS) 9. Ability to provide informed consent 10. For female patients only, willingness to use FDA-recommended birth control (http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356 451.pdf) until 6 months post treatment. 11. 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, or Human Immunodeficiency Virus (HIV) 6. Pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers 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 (lupus, rheumatoid arthritis, scleroderma, etc.) 9. Anticoagulation other than ASA. 10. Hemoglobin < 10 g/dl or platelets < 100 k/ml 11. Is unable or unwilling to provide informed consent 12. Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation |
Country | Name | City | State |
---|---|---|---|
United States | Hackensack Meridian Health | Hackensack | New Jersey |
United States | Throne Biotechnologies | Paramus | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Throne Biotechnologies Inc. | Hackensack Meridian Health |
United States,
Delgado E, Perez-Basterrechea M, Suarez-Alvarez B, Zhou H, Revuelta EM, Garcia-Gala JM, Perez S, Alvarez-Viejo M, Menendez E, Lopez-Larrea C, Tang R, Zhu Z, Hu W, Moss T, Guindi E, Otero J, Zhao Y. Modulation of Autoimmune T-Cell Memory by Stem Cell Educa — View Citation
Zhao Y, Jiang Z, Delgado E, Li H, Zhou H, Hu W, Perez-Basterrechea M, Janostakova A, Tan Q, Wang J, Mao M, Yin Z, Zhang Y, Li Y, Li Q, Zhou J, Li Y, Martinez Revuelta E, Maria Garcia-Gala J, Wang H, Perez-Lopez S, Alvarez-Viejo M, Menendez E, Moss T, Guin — View Citation
Zhao Y, Jiang Z, Zhao T, Ye M, Hu C, Yin Z, Li H, Zhang Y, Diao Y, Li Y, Chen Y, Sun X, Fisk MB, Skidgel R, Holterman M, Prabhakar B, Mazzone T. Reversal of type 1 diabetes via islet beta cell regeneration following immune modulation by cord blood-derived — View Citation
Zhao Y, Knight CM, Jiang Z, Delgado E, Van Hoven AM, Ghanny S, Zhou Z, Zhou H, Yu H, Hu W, Li H, Li X, Perez-Basterrechea M, Zhao L, Zhao Y, Giangola J, Weinberg R, Mazzone T. Stem Cell Educator therapy in type 1 diabetes: From the bench to clinical trials. Autoimmun Rev. 2022 May;21(5):103058. doi: 10.1016/j.autrev.2022.103058. Epub 2022 Jan 31. — View Citation
Zhao Y. Stem cell educator therapy and induction of immune balance. Curr Diab Rep. 2012 Oct;12(5):517-23. doi: 10.1007/s11892-012-0308-1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment Adverse Events in T1D Subjects | The occurrence of treatment-related adverse events will be evaluated post the treatment with SCE therapy. | 6 month | |
Secondary | Preliminary efficacy of SCE therapy to improve beta cell function | Preliminary efficacy as measured by Area under the C-peptide curve (AUC) over the first 2 hours of a 3-hour mixed meal tolerance test (MMTT) | 12 months | |
Secondary | Preliminary efficacy of SCE therapy to improve glucose control | Change in HbA1C levels over time | 12 months | |
Secondary | Preliminary efficacy of SCE therapy to reduce insulin dose | Change in daily insulin requirements | 12 months | |
Secondary | Efficacy of SCE therapy in immune modulation | Measurements of immune markers at baseline, 1, 3, 6, 9, and 12 months. Peripheral blood mononuclear cells (PBMC) will be collected and tested by flow cytometry. | 12 month |
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