Clinical Readiness Skin Punch Biopsy Sample Collections

HeartWorks, Inc.100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Congenital Heart Disease (CHD)Congenital Heart Defect

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Successful manufacture of induced pluripotent stem cells

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

Time frame: 12 months

Central Contacts

Adam Armstrong

CONTACT

(507) 577-1764 clinical@webuildhearts.org

Data from ClinicalTrials.gov

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