Recruiting
Phase 3

Stem Cell Educator

Sponsor:

Throne Biotechnologies Inc.

Code:

NCT04011020

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 10+

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 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.

Conditions

Type 1 Diabetes

Study ID

NCT04011020

Start date

Sep 20, 2022

Status verified date

Sep, 2026

Completion date

Dec 20, 2028

Anticipated

Primary completion date

Oct 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

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.

Interventions

Stem Cell Educator therapy

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.

Primary outcome measure

  • Change in fasting C-peptide levels [ Time Frame: 3 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

Jennifer Anti-Ampratwum, RN, MBA

201 988 0290jennifer.anti@thronebio.com

Throne Biotechnologies

Recruiting

Paramus, New Jersey, United States, 07652

Contacts

Jennifer Anti-Ampratwum, RN, MBA

201 988 0290jennifer.anti@thronebio.com

Principal Investigator:

Yong Zhao, MD, PhD

More Information

Sponsor

Throne Biotechnologies Inc.

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • Type 1 diabetes, stem cells, cord blood, treatment, immune modulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Throne Biotechnologies Inc. on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.