Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05647213 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Feb 2026 to Sep 2027v7
  2. 3 versions Re-verified since Sep 20, 2023, no change to tracked fieldsv4-v6
  3. Site contact updatedv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2023 to Feb 3, 2023
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05647213
Lead Sponsor HeartWorks, Inc.
Conditions
(from sponsor)		 Univentricular Heart, Congenital Heart Disease, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Related terms Heart Defects, Congenital, Heart Diseases, Univentricular Heart
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov