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Recruiting NCT06588426

Clinical Readiness Skin Punch Biopsy Sample Collections

— Observational Congenital Heart Disease (CHD) Congenital Heart Defect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Congenital Heart Disease (CHD), Congenital Heart Defect. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Readiness Skin Punch Biopsy Sample Collection

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.

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.

Primary outcome measures

  • Successful manufacture of induced pluripotent stem cells [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT06588426 · IPSC-CL-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗