Clinical Readiness Skin Punch Biopsy Sample Collections

Last updated: June 23, 2025
Sponsor: HeartWorks, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Congenital Heart Disease

Treatment

N/A

Clinical Study ID

NCT06588426
IPSC-CL-002
  • Ages > 18
  • All Genders

Study Summary

This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 and older

  • Congenital heart disease

  • Likely to qualify for an active clinical trial under IND 28611 in the future

Exclusion

Exclusion Criteria:

  • Previous cardiac transplantation

  • Unable or unwilling to consent

  • HIV diagnosis

  • Hepatitis diagnosis

Study Design

Total Participants: 100
Study Start date:
September 13, 2024
Estimated Completion Date:
July 31, 2027

Study Description

This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.

Connect with a study center

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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