Clin2
NCT05647213Possibly a fitRecruiting

Skin biopsy study of stem-cell therapy for congenital heart disease

Univentricular HeartCongenital Heart DiseaseHeart Failure NYHA Class IIIHeart Failure NYHA Class IV

Part of Genetic & congenital, Heart & circulation clinical trials.

This early study takes a small skin sample to make a personalized type of heart stem cells in the future. It is testing whether this approach is safe and feasible for people with complex single-chamber congenital heart disease and advanced heart failure.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
50 people
Ages
18 years to 40 years
Study type
Interventional

Who can take part

  • You are age 18 to 40 and can understand and sign consent
  • You have univentricular (single-chamber) congenital heart disease
  • You have advanced heart failure with high symptom burden (NYHA class IV) and weak pumping (ejection fraction under 40%)
  • Your heart doctors expect you may survive about 1 to 1.5 years when the skin sample is taken
  • You are either waiting long for a transplant, were denied a transplant, or need a heart machine for support
  • You can follow study visits and have someone able to help you—especially the first 3 weeks after treatment is given

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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