Biomedical technology company Xeltis has received conditional approval from the Paul Erlich Institute in Germany to initiate the first clinical study of its tissue-engineered cardiovascular grafts.
Sponsored by the University of Zurich, the prospective, single-centre study is intended to assess the safety and efficacy of Xeltis’ autologous tissue-engineered vascular grafts in paediatric patients requiring completion of a total cavo-pulmonary connection.
The trial will enrol up to ten patients and will be performed at Heart Center Leipzig, Germany.
Principal investigator of the study Martin Kostelka said that the new grafts can deliver life-saving therapy for children born with cardiovascular defects due to its expected longevity, ability to grow and very low risk of thrombosis and infection.
”We very much look forward to enrolling our first patient in this important trial,” Kostelka added.
The company expects to enrol first patient in 2012.