Partner 2: corlife oHG (corlife)

Sponsor of the Clinical Study, Processing of DAH, WPL for WP3 and 5

Corlife is an innovative lifesciences start-up, located in Hannover, Germany. Since 2006, the company has been developing and supplying products and technologies in the fields of cardiovascular and cardiothoracic surgery. corlife is specialized in stented and stentless devices based on tissue-engineered matrix composites which integrate into the patient's body and which become indistinguishable from the patient's own tissue. corlife's proprietary technologies are based on various international patents and patent applications. The company has its own capacities to produce and for quality assurance. corlife already avails of experience in the manufacturing, regulatory approval and clinical examination of tissue preparations at European level and sells its own products. The decellularised pulmonary valve has been approved in Germany. Mutual recognition procedures have been completed in Switzerland and Italy and are currently being carried out in other countries. A team of 16 specialists from various disciplines will support the implementation of the ARISE project.

Main tasks

Processing: corlife will manufacture all the decellularised heart valves for the proposed study. The base materials are fresh, non-cryopreserved homografts, delivered by the clinical participants and the tissue banks. Due to the very high quality requirements both for the samples and for the quality management, which is a legal requirement, the implants for the consortium can only be produced by corlife. Corlife has already initiated procedures for the approval of the decellularised human aortic valve and has participated in preparatory discussions with the German competent authority, the Paul-Ehrlich-Institut (PEI). On this basis, PEI has invited corlife to submit an application for approval, , which is currently being processed by corlife, meaning that clinical work will be able to begin early in the project.

corlife has already gained experience with how decellularised human tissue products and their surveillance is handled legally in European countries. Since the DAH does not fall under the classifications for medical devices or medicinal products in most European countries, many European Guidelines do not apply. National laws and regulations take precedence, rendering the regulatory process very complicates. Since corlife is already familiar with these procedures, these obstacles can be tackled relatively quickly.

Corlife is the sponsor of the surveillance and therefore responsible under the ICH Guidelines to ensure a safe and effective study. The responsibility of regulatory affairs is to organize a clinical study consistent with all European and national regulations, to monitor the surveillance and to report all events with the authorities. Monitoring consists of data collection, plausibility assessment, completing the data sets as applicable, analysing those data and summarising all information in reports. This responsibility is not divisible and all monitoring activities are therefore managed by corlife.

Contributors to ARISE

Dr Michael Harder, Managing Partner
Nicolin Heister, Head Regulatory Affairs
Carmen Puschmann, Regulatory Affairs
Bettina Giere, Manufacturing, Quality Manager
Christina Bruning, Manufacturing, Process Coordination
Miriam Baritsch, Technician
Janine Schalk, Technician