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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: Recruiting Phase 1 study of Congenital Heart Disease and Heart Failure NYHA Class III, sponsored by HeartWorks.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary safety endpoint is short term safety defined as the rate of new or worsening serious adverse events (SAE) from any System Organ Class (SOC) within 3 months of the iPSC-CL delivery as compared to the control arm.
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 |
What NCT05647213 shows while recruiting
NCT05647213 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 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Congenital Heart Disease
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 NCT05647213's enrollment target sits among peer trials
50 41st of 63 higher than 18 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease 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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