Recruiting
Phase 2
Phase 3

Stem Cell Educator

Sponsor:

Throne Biotechnologies Inc.

Code:

NCT04011020

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Stem Cell Educator therapy

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes

Study ID

NCT04011020

Start date

Sep 20, 2022

Status verified date

Apr, 2024

Completion date

Jun 20, 2025

Anticipated

Primary completion date

Oct 20, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

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/UCM356451.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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment of T1D with Stem Cell Educator therapy

Recruited T1D subjects will receive one treatment with SCE therapy.

experimental: Conventional insulin therapy

Control group will receive conventional insulin therapy.

Interventions

Stem Cell Educator therapy

Patients with T1D will be evaluated by the study principal investigator or co-investigators. Informed consent will be obtained at the initial screening visit. The initial screening visit will occur within 30 days of initiation of SCE therapy. The second screening visit will occur within 7 days of therapy. Subjects who meet all criteria will be scheduled for treatment. All enrolled subjects will receive treatment with the SCE system consisting of a single session of mononuclear cells (MNC) collection by apheresis where 10 L of blood will be processed on day -1. The MNC product will then be exposed over to the SCE and on day 0 the product will be infused intravenously back to the patient.

Primary outcome measure

  • Incidence of Treatment Adverse Events in T1D Subjects [ Time Frame: 6 month ]

Central Contacts and Locations

Central contacts

YONG ZHAO, MD,PhD

201 988 0290Yong.Zhao@ThroneBio.com

Locations

Throne Biotechnologies

Recruiting

Paramus, New Jersey, United States, 07652

Contacts

Yong Zhao, MD,PhD

201-988-0290yong.zhao@thronebio.com

Principal Investigator:

Boris Veysman, MD

More Information

Sponsor

Throne Biotechnologies Inc.

Last update posted

Apr 29, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Throne Biotechnologies Inc. on 2024-04-29.