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

NCT05647213 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-13

No results posted yet for this 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

  • Univentricular Heart
  • Congenital Heart Disease
  • Heart Failure NYHA Class III
  • Heart Failure NYHA Class IV

Interventions

BIOLOGICAL

iPSC-CL

Autologous IPSCL

Sponsors & Collaborators

  • HeartWorks, Inc.

    lead OTHER

Principal Investigators

  • Timothy J Nelson, M.D., Ph.D. · HeartWorks, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2027-09-30
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05647213 on ClinicalTrials.gov