Clinical Readiness Skin Punch Biopsy Sample Collections

HeartWorks

Status: Enrolling

Conditions: Congenital Heart Defect; Congenital Heart Disease (CHD)

Study type: Observational

Funder types: Other

Identifiers

NCT06588426

IPSC-CL-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Participants with congenital heart disease