IOR PROMETEO Laboratory
IOR PROMETEO Laboratory undertakes to manage, implement and coordinate regenerative medicine products and tissue engineering in orthopedic manufacturing and research and development.
It provides consultancy and training services at regional, national and international levels in the field of regenerative medicine, tissue engineering in orthopedic and maxillofacial surgery.
IOR PROMETEO Laboratory has the following organizational chart:
Tissue Factory: authorized by CNT, in compliances with Law 91/99, it is the referent Bank for Emilia-Romagna region for musculoskeletal tissues, with the specific aim of collect, validate, process, manufacture, identify, storage and distribute the drawn tissues, certifying qualification, security and safety. It supplies – for implantation and transplantation purposes, bone segments, tendon and stripes, adequately kept, under microbiological control and deriving from donors whose identity and qualification has been previously evaluated. The processation of tissue undergoes in class A and under controlled contamination ambient. BTM projects and develops news tissutal products, even in collaboration with private companies being them national or international. It collaborates to clinical protocols within regenerative medicine, supplying lyophilized or demineralized tissues to being combined to grow factors.
Cell Factory: authorized by AIFA, for extensive cell manipulation within class A controlled contamination ambient; is dedicated to the isolation, expansion and release of autologous chondrocytes and mesenchymal stem cells, applying GMP. It deals with the identification and the development alternative sources for cells with respect to the ones in use and new bio-materials to use in combination with stem cells for the regeneration of bone, cartilage and tendons. It is involved in clinical trials developing and supplying products for cell therapies.
Quality control and microbiology Laboratory: authorized by AIFA, performs GMP process tests and releases of products for extensive cell manipulation, carried out within the Cell Factory. It performs microbiological controls on tissues stocked within the Cell and the musculoskeletal tissue Bank and offers microbiological analytical service control and clinical to the operational units of IOR (Istituto Ortopedico Rizzoli). It controls material quality level entering the Cell Factory GMP storage. It is involved in clinical trials developing and supplying quality controls for products for cell therapies. It collaborates with other operational units for the implementation of studies and research activities.
Laboratory for the analysis and the characterization of tissues or engineered bio-materials: it deals with mechanical and biological study of “hybrid” new materials. It undertakes in the evaluation of mechanical competencies measured through dedicated proof machinery and tools where loads and stresses are applied following protocols in strict compliance with the Law. It deals therefore with evaluation of specific characteristics of biological systems and interactions between them and the used materials.
Biobanks: storage of human tissue and cells, within and through validated cryoconservation tools and machinery, monitoring temperature, alarm manager, GMP compliance programmed services.
The Bank for Cells and Musculoskeletal tissue, the Cell factory and the Quality control and microbiology Laboratory are certificated for the EA 37 sector: “Projecting and supplying of training events, internships, catalogue courses, seminars and study days”. They offer tailored training courses; within the ambit of specific collaborations, they supply catalogue courses agreed with the customer on the following themes:
- implementation and management of sterile rooms
- development of a GMP structure in compliance with extensive cell manipulation requirements
- development of integrated ISO-GMP-sectoral requirement systems
- development and management of quality control laboratories
- development and management of cell and tissue banks
Regenerative medicine in orthopedic surgery: usage of grow factor, non relevant manipulation bank bone, engineered tissues.
IOR Prometeo Laboratory researches and develops new products based upon:
- alternative cell sources with respect to the ones nowadays in use
- new biomaterials to use in combination with stem cells for bone, cartilage and tendon regeneration.
In coordination with IOR and other Italian Hospitals clinical translational research structures, it is involved in clinical trials developing and supplying products for cell therapy, with protocols authorized by Ethic Committee within the hospital housing the trial and by ISS (Istituto Superiore di Sanità).
It is at the point of activation a group of experts dedicated to clinical trials monitoring when using advanced therapy pharmaceutical products.
Technological relevant resources:
- HVAC (sterile rooms) with 4 lass A and B laboratories classe A e B.
- Cappe biohazard a flusso unidirezionale.
- Microscopi rovesciati.
- Incubatori a CO2.
- Isolatore (glove box) di classe A con background D.
- Contenitori criobiologici e criogenici di azoto liquido.
- Termiciclatore per PCR real time.
- Centrifughe refrigerate.
- Bact Alert 3D.
- Endosafe PTS100 per LAL test.
- Bactec 9050.
- Microscan Walkaway Sistema semiautomatico Mini API per identificazione e antibiogramma di aerobi ed anaerobi.
- Cappe chimiche a filtrazione molecolare.
- Sega a nastro.
- Apparecchiatura a controllo alfa-numerico per taglio.
- Mulino ultracentrifugo.
- Ultracongelatori a -80°C.
- TMA Tissue Macro Arrays
- Analizzatore di immagini “Gel Logic”.
IOR Prometeo Laboratory Partner:
Tissutal therapy Structure within AO Niguarda: is composed by the regional reference Center for in vitro human epidermis colture (DGR n. 39806 of 24/02/88), by the Bank for cryonconservation of tissues and the deep wounds and burns ambulatory. The Center for human epidermis colture and tissue cryoconservation deals with activity that are considered as purposes of the National Healthcare System, both form clinical (transplants) and technical-logistic standpoints (computerized national coordination between healthcare companies). The laboratories grant qualitative and safety levels for the processes for the treatment and the storage, in compliance with 2004/23/CE. European Directive.
The equipment comprises 600 sq.meters of controlled contamination laboratory, under the most recent GMP requirements for the manipulation of tissue destined to cryoconservation.
In particular different tissues of different typologies are treated:
- derm and engineered epidermis
- dermal derivation stem cells
The equipe collaborates with the Center for Nanomedicine and Tissutal engineering, through a synergic approach finalized to identify new therapeutic solutions among the most spread diseases.
The Epidermis Bank, with its thousands of square meters of laboratories, is the largest Italian high Biosafety which are carried out on tissue engineering, ie cultivation of skin and cartilage and tissue cryopreservation. The center is considered a benchmark at regional and national level, and takes advantage of the synergy and collaboration with medical, pharmaceutical, chemistry, biomaterials, biomedical engineering and biotechnology. The cell factory bank produces skin and cartilage.
Thanks to the technologies supplied to laboratories, more than 100,000 cm2 of engineered skin are annually produced from stem cells derived by dermis or epidermis of donors. In 1996, the first Italian plant in vitro cultured cartilage has been performed. This technique applied to the knee surgery has made it possible to treat even the most serious injuries, until shortly before judged incurable. The artificial ligament has also allowed not to sacrifice more healthy parts to rebuild, making the surgery less traumatic and faster recovery. Through the activity of cryopreservation, the bank collects and stores samples of skin and cartilage, constituting a reference center for the whole region Lombardy. Dedicated software allows direct connection with the National Transplant Centre, thus ensuring a degree of traceability of donated tissue.