Fraunhofer Institute for Toxicology and Experimental MedicineWe are a highly specialized, academia-affiliated research center for early-phase and proof-of-concept clinical trials
Fraunhofer ITEM has many years of experience and expertise in the field of clinical airway research, complemented by a unique state-of-the-art infrastructure for performing clinical trials. Our focus of research is on airway diseases, in particular asthma, COPD, and allergic rhinitis, and on interstitial lung diseases, especially idiopathic pulmonary fibrosis (IPF). Other therapeutic areas have been added over the past five years, including atopic dermatitis, inflammatory diseases and vaccine studies.
At the Clinical Research Center Hannover (CRC Hannover), one of Europe’s leading-edge non-hospital clinical research centers, we operate in a collaborative working environment that includes outpatient clinics and overnight facilities for study participants, advanced medical equipment, magnetic resonance imaging (MRI) systems, and a state-of-the-art biobank for storing biological samples.
In cooperation with our partner at the CRC Hannover, the Hannover Medical School, we conduct clinical trials also in other therapeutic areas, mainly atopic dermatitis, psoriasis, and sleep disorders.
Fraunhofer ITEM scientists have developed a wide range of challenge models to test the human response, for example, to inhaled allergens (inhaled allergen challenge; Fraunhofer Allergen Challenge Chambers in particular). We have direct access to human samples such as bronchoalveolar lavage (BAL), sputum, serum, and plasma, and have our own immunological lab where we have access, for example, to flow cytometry and chip cytometry and can perform ultrasensitive biomarker measurements on an MSD multiplex platform.
A large database of both prescreened patients (with asthma, allergic rhinitis, COPD, atopic dermatitis, or idiopathic pulmonary fibrosis) and healthy volunteers and a professional recruitment team ensure reliable time lines in the performance of clinical trials. Our research department furthermore has access to five challenge chambers – the Fraunhofer Allergen Challenge Chambers in particular – for proof-of-concept studies with sophisticated study designs using natural pollen (grass, birch), allergen extracts (e.g. cat, house dust mite), ozone, or hypoxia.
