RECRUITING

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

Quick Facts

Study Start:2022-09-20

Study Completion:2025-06-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04011020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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/UCM356451.pdf) until 6 months post treatment. 11. Must agree to comply with all study requirements and be willing to complete all study visits	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

Inclusion Criteria

Exclusion 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/UCM356451.pdf) until 6 months post treatment.
11. Must agree to comply with all study requirements and be willing to complete all study visits

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

Contacts and Locations

Study Contact

YONG ZHAO, MD,PhD

CONTACT

201 988 0290

Yong.Zhao@ThroneBio.com

Principal Investigator

YONG ZHAO, MD,PhD

STUDY_CHAIR

Throne Biotechnologies Inc.

Study Locations (Sites)

Hackensack Meridian Health

Hackensack, New Jersey, 07601

United States

Throne Biotechnologies

Paramus, New Jersey, 07652

United States

Collaborators and Investigators

Sponsor: Throne Biotechnologies Inc.

YONG ZHAO, MD,PhD, STUDY_CHAIR, Throne Biotechnologies Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-20

Study Completion Date2025-06-20

Study Record Updates

Study Start Date2022-09-20

Study Completion Date2025-06-20

Terms related to this study

Additional Relevant MeSH Terms

Type 1 Diabetes