Clinical Readiness Skin Punch Biopsy Sample Collections

Recruiting

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

• Registration Number: NCT06588426
• Lead Sponsor: HeartWorks, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study Start: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2027-01
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful manufacture of induced pluripotent stem cells	12 months	Outcome measured will be the manufacture of iPSC that meets pre-determined acceptance criteria.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States