RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Feasibility of Autologous Induced Pluripotent Stem Cells of Cardiac Lineage in Subjects With Congenital Heart Disease

Quick Facts

Study Start:2023-02-03
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05647213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clint Hagen, M.S.
CONTACT
1-(507) 577-1764
clint@webuildhearts.org

Principal Investigator

Timothy J Nelson, M.D., Ph.D.
STUDY_DIRECTOR
HeartWorks, Inc.

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55901
United States

Collaborators and Investigators

Sponsor: HeartWorks, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-03
Study Completion Date2029-02

Study Record Updates

Study Start Date2023-02-03
Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

  • univentricular
  • heart disease
  • iPSC
  • induced pluripotent stem cell

Additional Relevant MeSH Terms

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