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NCT04011020 · ClinicalTrials.gov registry record · Phase 2

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

A Phase 2 study of Type 1 Diabetes, sponsored by Throne Biotechnologies.

Recruiting
Registry status
Phase 2
Development phase
50
Enrollment target
2
Study locations

NCT04011020 is a Phase 2 study of Type 1 Diabetes that is actively recruiting participants, run by Throne Biotechnologies. The registered enrollment target is 50 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT04011020, a Phase 2 study of Type 1 Diabetes, is actively recruiting participants, sponsored by Throne Biotechnologies.

RECRUITING
Registry status
Phase 2
Development phase
50 participants
Enrollment target
2
Study locations

Study 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 Studied

Type 1 Diabetes

Interventions

  • COMBINATION_PRODUCT Stem Cell Educator therapy

Study Locations (2)

New Jersey

  • Hackensack Meridian Health - Hackensack
  • Throne Biotechnologies - Paramus

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2022-09-20
Est. Completion 2025-06-20
Phase Phase 2

Sponsor

Throne Biotechnologies

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04011020

The ClinicalTrials.gov registry entry for NCT04011020 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (94% lower). The listed sponsor is Throne Biotechnologies, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Stem Cell Educator therapy is the first listed.

NCT04011020 reports 2 study locations spanning 1 distinct geographic area - top geographies include New Jersey.

Frequently Asked Questions

What is clinical trial NCT04011020 about?

NCT04011020 is a clinical study titled "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 modula...

What is the current status of trial NCT04011020?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2022-09-20. Estimated completion is 2025-06-20.

What conditions does trial NCT04011020 study?

This clinical trial studies the following conditions: Type 1 Diabetes.

What interventions are being tested in trial NCT04011020?

The interventions under investigation include: Stem Cell Educator therapy (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT04011020?

This trial is sponsored by Throne Biotechnologies, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04011020 being conducted?

This trial has 2 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.