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NCT05647213 · ClinicalTrials.gov registry record · Phase 1
Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
A Phase 1 study of Congenital Heart Disease and Heart Failure NYHA Class III, sponsored by HeartWorks.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05647213 is a Phase 1 study of Congenital Heart Disease and Heart Failure NYHA Class III that is actively recruiting participants, run by HeartWorks. The registered enrollment target is 50 participants, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05647213, a Phase 1 study of Congenital Heart Disease and Heart Failure NYHA Class III, is actively recruiting participants, sponsored by HeartWorks.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are: * Is this product safe to deliver to humans * Is the conduct of this trial feasible Participants will be asked to: * Agree to testing and monitoring before and after product administration * Receive investigational product * Agree to lifelong follow-up Researchers will compare subjects from the same pool to see if there is a difference between treated and untreated subjects.
Conditions Studied
Interventions
- BIOLOGICAL iPSC-CL
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-02-03 |
| Est. Completion | 2029-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05647213
The ClinicalTrials.gov registry entry for NCT05647213 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (89% lower). The listed sponsor is HeartWorks, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which iPSC-CL is the first listed.
NCT05647213 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT05647213 about?
NCT05647213 is a clinical study titled "Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease". The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are: * Is this product safe to deliver to humans * Is the conduct of this trial feasible Participants will be asked to...
What is the current status of trial NCT05647213?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2023-02-03. Estimated completion is 2029-02.
What conditions does trial NCT05647213 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Heart Failure NYHA Class III, Heart Failure NYHA Class IV, Univentricular Heart.
What interventions are being tested in trial NCT05647213?
The interventions under investigation include: iPSC-CL (BIOLOGICAL).
Who is sponsoring clinical trial NCT05647213?
This trial is sponsored by HeartWorks, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05647213 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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