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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
HeartWorks, Inc.
Study ID
NCT05647213
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • iPSC-CL — BIOLOGICAL
    Autologous IPSCL

Study Details

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.

Key Dates

Start date
Feb 3, 2023
Status verified
Jun 2025
Primary completion
Sep 30, 2027
Completion
Feb 28, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treated
    Subjects in Treated arm will receive one dose of Investigational Product. Within this arm are three dose levels. Dose level selection will be determined by product availability subjects have available product and when they can be treated. Dose levels will escalate in order of treatment date.
  • No Intervention: Control
    Subjects who enroll but do not receive Investigational Product will be placed in the control arm.

Primary Outcome Measure

Short term safety [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55901
Karen Miller
[email protected]
Lori Riess
[email protected]
Rebecca K Ameduri, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic· Rochester, MN

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