The activity of the Centre for Regenerative Medicine ”Stefano Ferrari” (CMR) of the University of Modena and Reggio Emilia is focused on advanced therapies for cell and gene therapy and basic and translational research on epithelial and hematopoietic stem cells.
Autologous cultures of limbal stem cells are currently used for corneal regeneration and restoration of visual acuity in patients with severe corneal chemical and thermal burns associated to total unilateral or severe bilateral limbal stem cells deficiency. Such cultures obtained the designation of orphan medicinal product by the European Medicines Agency (EMA) in 2008 and conditional marketing authorization in 2015.
Pre-clinical development stage
Definition of experimental and clinical protocols aimed at clinical application of:
- epidermal stem cells in different cutaneous pathologies;
- stem cells of conjunctival, urethral and buccal epithelia in traumatic destruction of the conjunctival epithelium, dry-eye Syndrome, posterior hypospadias, recurring urethral stenosis, reconstructive surgery of blindness due to bilateral ocular surface damage;
- stem cells of respiratory epithelia for the reconstruction of upper respiratory tract.
Ongoing Phase I/II clinical trials for ex-vivo gene therapy of laminin 5-dependent Junctional Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa.
Definition of clinical protocols for ex-vivo gene therapy of Collagen XVII-dependent Junctional Epidermolysis Bullosa.
Definition of experimental protocols for ex-vivo gene therapy of laminin 5-dependent and Collagen XVII-dependent Junctional Epidermolysis Bullosa and Collagen VII-dependent Dystrophic Epidermolysis Bullosa by new generation SIN-retroviral vectors and/or homologous recombination technology.
- culture and functional characterization of epithelial stem cells (epidermis, cornea, conjunctiva, urethra and oral mucosa) and hematopoietic stem cells;
- studies of molecular mechanisms regulating self-renewal, proliferation and differentiation of squamous epithelial and hematopoietic stem cells by conventional methods integrated with genomic (genotyping and next generation sequencing), epigenomic and transcriptomic technologies;
- functional and molecular characterization of leukemia stem cells;
- genetic modification and gene editing technologies
CMR has a 2000 sq meters GMP facility (AIFA decree n. aM – 169/2014) containing 17 independent Class B rooms, which is run by the University spin-off Holostem Terapie Avanzate, a biotechnology company founded in 2008 through the profitable union between the scientific know-how of the University of Modena and Reggio Emilia and its researchers and the industrial know-how of Chiesi Farmaceutici S.p.A.
CMR hosts the Interdepartmental Centre for Stem Cells and Regenerative Medicine (CIDSTEM), accredited by regional government as industrial research laboratory and technology transfer centre within the Emilia-Romagna High Technology Network, founded to gather the regional academic institutions and public research centres and provide skills, facilities and resources to the business sector.