Pisa Biobank and Tuscany Regional Biorepository

Departmental Section of Biobanks (SOD Biobanche) of the Azienda Ospedaliera Universitaria Pisana, consists of a Tissue and Cell institute, the Heart Valve Bank, and a biorepository, the Regional Biologic Archive. A clean room consisting of three laboratories (1 class C and 2 class B) represents a core facility for some of the processes and projects of the biobank. The Regional Biological Archive is a biobank which currently carries out as an institutional task the storage of serum, plasma and non-viable cells of multiorgan, multi-tissue donors and donors of corneas, as well as solid organ transplant recipients of the Tuscany Region, providing the possibility of reviewing and re-evaluating even at a distance of years the donor/recipient pairs. The mission of SOD Biobanche is to act as a transversal service platform in the field of biobanking of biological material. In this broader perspective the structure is open to new projects concerning biobanking, some of which are already in the activation phase, such as a bank for urogenital tissues, a biobank of tumors of the musculoskeletal system and an advanced therapy protocol for the use of partially osteoinduced expanded mesenchymal stem cells.

Autologous bone marrow expanded mesenchymal stem cells in patellar tendinopathy: protocol for a phase I/II, single-centre, randomized with active control PRP, double-blinded clinical trial

Introduction Patellar tendon overuse injuries are common in athletes. Imaging may show a change in tissue structure with tendon thickening and disruption of the intratendinous substance. We wish to test the hypothesis that both autologous bone marrow expanded mesenchymal stem cells and autologous leukocyte-poor platelet-rich plasma (LP-PRP) implanted into the area of the disrupted tendinopathic patellar tendon will restore function, but tendon regeneration tissue will only be observed in the subjects treated with autologous bone marrow expanded mesenchymal stem cells. Methods and analysis This is a single-centre, pilot phase I/II, double-blinded clinical trial with randomisation with active control. Twenty patients with a diagnosis of patellar tendinopathy with imaging changes (tendon thickening and disruption of the intratendinous substance at the proximal portion of the patellar tendon) will be randomised in a 1:1 ratio to receive a local injection of either bone-marrow autologous mesenchymal stem cells (MSC), isolated and cultured under GMP at The Institute of Biology and Molecular Genetics (IBGM) (Spain) or P-PRP. The study will have two aims: first, to ascertain whether a clinically relevant improvement after 3, 6 and 12 months according to the visual analogue scale (VAS), Victorian Institute of Sport Assessment for patellar tendons (VISA-P) and dynamometry scales (DYN) will be achieved; and second, to ascertain whether the proposed intervention will restore tendon structure as determined by ultrasonography (US), Doppler ultrasonography (DUS), and innovative MRI and ultrasound techniques: Magnetic Resonance T2 FAT SAT (UTE, Ultrashort Echo TE) sequence and Ultrasound Tissue Characterization (UTC). Patients who are randomised to the P-PRP treatment group but do not achieve a satisfactory primary endpoint after 6 months will be offered treatment with MSC. Trial registration NCT03454737.