RecruitingPhase 2Phase 3NCT04011020

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

Sponsor

Throne Biotechnologies Inc.

Enrollment

50 participants

Start Date

Sep 20, 2022

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

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.

Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called Stem Cell Educator therapy for people with recently diagnosed type 1 diabetes. The therapy works by filtering a patient's blood through a device containing special stem cells from umbilical cord blood, which are thought to calm the immune system's attack on insulin-producing cells in the pancreas. **You may be eligible if...** - You are 14 or older - You have been diagnosed with type 1 diabetes within the past 2 years - You have at least one diabetes-related autoantibody in your blood (such as GAD65, IAA, IA2, or ZnT8) - You still produce some insulin (fasting C-peptide > 0.3 ng/ml) - Your HbA1c (3-month blood sugar average) is below 10% - You have good vein access and are using a continuous glucose monitor **You may NOT be eligible if...** - You have had type 1 diabetes for more than 2 years - You have no remaining insulin production - You have very poor blood sugar control (HbA1c ≥ 10%) - You are pregnant or unable to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTStem 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.