Stem Cell Therapy for the Treatment of Congenital Heart Disease
Research type
Research Study
Full title
Stem Cell Therapy for the Treatment of Congenital Heart Disease: Mending the Youngest Heart
IRAS ID
156551
Contact name
Massimo Caputo
Contact email
Sponsor organisation
University of Bristol
Clinicaltrials.gov Identifier
2424,
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Despite recent advances in cardiac surgery, congenital heart disease (CHD) still represents an unmet clinical need due to the limited durability of materials used to repair cardiac defects and consequent development of heart failure. The advent of stem cell therapy and tissue engineering has raised new hope for the treatment of CHD patients. The aim of this project is to upgrade the valved-conduits and patches commonly used in reconstructive CHD surgery, by creating biomaterials/medical devices endowed with potential to grow, remodel and regenerate the failing right ventricle in vivo. We will test different cell products, including autologous stem cells from neonatal heart and bone marrow and blood, and cardiovascular cells derived from autologous induced pluripotent cells, to verify the optimal regenerative component within the medical device. We shall then use an in vivo CHD piglet model to test the new devices for proof of concept of feasibility and efficacy. If feasibility and efficacy is demonstrated we will perform a first-in-human clinical trial, comparing bio-engineered and conventional scaffolds for reconstruction of the right ventricular outflow tract and pulmonary arteries. This will be the subject of future applications for regulatory approval
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/1064
Date of REC Opinion
25 Jun 2015
REC opinion
Further Information Favourable Opinion