Clinical Readiness Skin Punch Biopsy Sample Collections

Clinical Readiness Skin Punch Biopsy Sample Collection

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06588426

Enrollment

100

Registered

2024-09-19

Start date

2024-09-13

Completion date

2027-07-31

Last updated

2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Defect, Congenital Heart Disease (CHD)

Keywords

CHD, Congenital Heart Defect

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactAdam Armstrong

clinical@webuildhearts.org(507) 577-1764

Outcome results