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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: Recruiting Phase 2 study of Type 1 Diabetes, sponsored by Throne Biotechnologies.
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 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Interventions
- COMBINATION_PRODUCT Stem Cell Educator therapy
Study Locations (2)
New Jersey
- Hackensack Meridian Health - Hackensack
- Throne Biotechnologies - Paramus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-09-20 |
| Est. Completion | 2025-06-20 |
| Phase | Phase 2 |
What NCT04011020 shows while recruiting
NCT04011020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04011020's enrollment target sits among peer trials
50 87th of 198 higher than 107 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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