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.

Similar studies

Other trials that look related to this one.

NCT06371937Recruiting
Heart and blood vessel disease biobank study

This study creates a collection of skin cells (turned into stem cells in a lab) from people with various heart and blood vessel conditions. It aims to find new ways to understand and treat these diseases.

London, Ontario
NCT06588426Recruiting
Skin punch biopsy collection for heart disease research

This trial collects a small skin sample (like a biopsy) from people with congenital heart disease. The samples help prepare for future clinical trials that may test new heart treatments.

Rochester, Minnesota
NCT06866600Not yet recruiting· Phase 1/Phase 2
Stem cell heart injections for severe heart failure

This trial tests whether injecting special heart muscle cells (made from stem cells) during a heart bypass or a heart pump surgery can help improve your heart's function. It is for people with severe heart failure who are already planning one of these surgeries.

Nanjing, Jiangsu
NCT07496372Recruiting· Phase 3
Stem cell injection for advanced heart failure

This trial tests a treatment made from stem cells that are turned into heart muscle cells and injected directly into the heart. It is for people with advanced heart failure who are already on the best available medicines and who are scheduled to have bypass surgery.

Tianjin, Tianjin Municipality
NCT04396899Recruiting· Phase 1/Phase 2
Stem cell heart patch for advanced heart failure

This early-phase study tests a lab-made heart tissue (“engineered myocardium”) placed surgically to help the heart work better in people with advanced heart failure. It mainly checks safety first, and also looks for signs the patch can improve heart function in selected patients.

Göttingen, Lower Saxony
NCT07861035Recruiting· Phase 1
Stem cell therapy during heart bypass surgery for weakened heart muscle

This study tests a new treatment using donor stem cells injected into the heart during scheduled bypass surgery. The goal is to see if these cells help improve heart function in people with heart failure due to blocked arteries and a weak heart pump.

Seongnam-si, Gyeonggi-do

Hear when a new Univentricular Heart trial opens

We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.