The director, Michael De Luca, and his main collaborator, Graziella Pellegrini, QP and Coordinator of the Cell Therapy, are considered international leaders in the field of stem cell biology of the epithelial lining targeted to their clinical application in regenerative medicine and are responsible for major scientific advances in the field of cell therapy and gene therapy of serious diseases otherwise un-treatable.
In addition to developing cultured epidermal stem cells used for life-saving therapy for patients with extensive burns (with hundreds of patients in collaboration with several hospitals) and therapy for stable vitiligo and the piebaldism (with hundreds of patients treated in Italy), they first described the possibility to reconstitute in vitro the urethral epithelium for clinical application in patients with severe hypospadias rear, as well as to reconstruct the epithelium of the oral mucosa for clinical application in patients with large deficits of the same.
Over the past decade, Michael De Luca and Graziella Pellegrini have developed a colture system and clinical application of stem cells for the limbo-corneal surface reconstruction corneal severely damaged and recovery of vision. Over the past 5 years, many international clinical centers have successfully reproduced these results.
The recent years acquired knowledge on the biology of human epidermal stem cells and their clinical application in cell therapy have allowed the working group headed by Prof. De Luca to gain the experience needed to correct genetic defects in a stable manner in stem cells from patients with genetic diseases of the skin, such as Epidermolysis Bullosa. This result led to successfully perform the first clinical trial (approved by the Ministry of Health) of ex vivo gene therapy in the form of junctional epidermolysis bullosa.
The CMR / CIDSTEM is a building, which opened in 2008, which is spread over 4 floors with a total area of 4,000 square meters, including 3,000 square meters of workshops and 1,000 square meters of floor technician.
In particular, it has a laboratory for basic research of 1,000 square meters, with 5 bedrooms for cell culture and gene transfer and laboratories are fully equipped to work in biochemistry, molecular biology, confocal microscopy, immunofluorescence, laser microdissection, flow cytometry, histology, cytology, real-time PCR. It also has centrifuges and other equipment and services such as cold rooms, warm room, cryostats, crioconservatori and emitters for cells.
It also has a workshop production of pharmaceutical GMP certified about 1,500 square meters, with 17 rooms for cell culture class B (according to Annex 1 cGMP) independent and fully dedicated to the preparation of cell cultures for clinical application in cell therapy and gene therapy and clinical trials, quality control and preparation of culture media. Each room is equipped with incubators for cell culture temperature, relative humidity and carbon dioxide concentration controlled; refrigerators and freezers for storage of reagents; laminar flow hoods for the machining of cells and tissues in a controlled environment (class A according to Annex 1 cGMP), centrifugal and cytocentrifuges, thermostatic baths, microscopes. Outside laboratories are classified as accessory equipment such as refrigerators and freezers for Ultra-Low precongelamento of tissues, crioconservatori in liquid nitrogen, PCR, fume hoods, robots for the automated execution of immunohistochemical staining and immunofluorescence, centrifuges, microscopes, irraggiatore and balances (analytical and semianalitica). There are also departments for the selection of the materials input and output, control laboratories histological and local washing and sterilization and terminals of the control systems and monitoring.