2026-04-14T03:03:21Zhttps://recercat.cat/oai/request

oai:recercat.cat:2445/1642882025-12-04T20:39:22Zcom_2072_1057col_2072_478800col_2072_478917

00925njm 22002777a 4500 dc Rodas Font, Gil author Soler, Robert author Balius, Ramón author Alomar, Xavier author Peirau, Xavier author García Alberca, Mercedes author Sánchez, Ana author Sancho, Javier author Rodellar, Cementina author Romero, Antonio author Masci, Lorenzo author Orozco, Lluís author Maffulli, Nicola author 2020-06-04T11:38:44Z 2020-06-04T11:38:44Z 2019-12-16 2020-06-04T11:38:44Z 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. Lligaments Cèl·lules mare Plasma sanguini Plaquetes sanguínies Traumatisme Ligaments Stem cells Blood plasma Blood platelets Traumatism 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