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Recruiting

NCT Number: NCT06588426

Clinical Readiness Skin Punch Biopsy Sample Collections

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.

Recruiting

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Defect Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and older
  • Congenital heart disease
  • Likely to qualify for an active clinical trial under IND 28611 in the future

Exclusion criteria

  • Previous cardiac transplantation
  • Unable or unwilling to consent
  • HIV diagnosis
  • Hepatitis diagnosis

Treatment and study plan

Primary outcomes

  1. Successful manufacture of induced pluripotent stem cells

    Time frame: 12 months

    Outcome measured will be the manufacture of iPSC that meets pre-determined acceptance criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Armstrong

CONTACT

[email protected]

(507) 577-1764

Sponsors and collaborators

Lead sponsor

HeartWorks, Inc.

Other

Registry information

Official study title

Clinical Readiness Skin Punch Biopsy Sample Collection

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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