A European consortium is putting a novel regenerative human heart valve to the test that may revolutionise the field of cardiovascular tissue engineering. Based on a special technology that removes all biological material from the valve, this novel medical product boosts immune tolerance and longevity.
Heart valve transplantation is the gold standard for treating acquired
and congenital valvular heart disease. The valves need to be
immunologically compatible, and for young patients the grafts need to
grow with the patient. Currently used mechanical or biological valves
are associated with the undesirable effects of clotting and
degeneration.
Previous work by the consortium partners resulted in the development of human-donated decellularised heart valves that have been treated to remove all biological material. The collagen matrix that is essentially left behind forms an excellent scaffold for autologous cells to grow into a new valve. Preliminary data in paediatric and adolescent patients indicate high immune tolerance.
The EU-funded
ESPOIR (European clinical study for the application of regenerative heart valves) project further tests these promising results in a four-year clinical trial. The consortium comprises eight leading paediatric cardiac surgical centres across Europe that plan to operate on over 200 patients during the trial.
Valves are provided by the tissue banks European Homograft Bank (EHB) and German Society for Tissue Transplantation (DGFG). The valves are transported cross-border, and the decellularisation process is carried out by a collaborating small enterprise. Eleven patients have been successfully treated with a decellularised pulmonary heart valve, and six more implantations are under way.
The consortium created a database to provide long-term data acquisition on the overall performance of the transplanted heart valves. The ESPOIR Registry contains data of 110 patients who received a decellularised homograft for pulmonary valve replacement.
ESPOIR's decellularised heart valve is envisioned to last up to 20 years, twice longer than the biological prosthesis. This will not only cut back on heart valve reoperation costs, it will also substantially improve the quality of life of operated patients by minimising side-effects while saving people's lives.