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
García Sancho, Javier
MetadataShow full item record
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.
Is part ofJournal of Orthopaedic Surgery and Research, 2019, vol. 14, article441
European research projects
The following license files are associated with this item:
Showing items related by title, author, creator and subject.
The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial Misericòrdia, Carles; Martínez Alonso, Montserrat; Pons Rodríguez, Anna; Pérez Lacasta, María José; Perestelo Pérez, Lilisbeth; Sala, Maria; Vidal, Carmen; Garcia, Montse; Toledo Chávarri, Ana; Codern, Núria; Feijoo Cid, Maria; Romero, Anabel; Pla, Roger; Soler González, Jorge; Castells, Xavier; Rué i Monné, Montserrat (BioMed Central, 2017)The decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary ...
Virgin olive oil enriched with its own phenolic compounds or complemented with thyme improves endothelial function: The potential role of plasmatic fat-soluble vitamins. A double blind, randomized, controlled, cross-over clinical trial Valls, Rosa M.; Farràs, Marta; Pedret, Anna; Fernández Castillejo, Sara; Catalán Santos, Úrsula; Romeu, Marta; Giralt, Montserrat; Sáez, Guillermo T.; Fitó, Montserrat; De la Torre, Rafael; Covas Planells, María Isabel; Motilva Casado, Mª José; Solà, Rosa; Rubió Piqué, Laura (Elsevier, 2017)The aim of the present study was to assess whether different functional virgin olive oils (FVOOs) with varying phenolic compounds (PC) could protect the plasmatic fat-soluble vitamins, which in turn could improve the ...
Impact of Virgin Olive Oil and Phenol-Enriched Virgin Olive Oils on the HDL Proteome in Hypercholesterolemic Subjects: A Double Blind, Randomized, Controlled, Cross-Over Clinical Trial (VOHF Study) Pedret, Anna; Catalán Santos, Úrsula; Fernandez-Castillejo, Sara; Farràs, Marta; Valls, Rosa M.; Rubió Piqué, Laura; Canela, Núria; Aragonés, Gerard; Romeu, Marta; Castaner, Olga; De la Torre, Rafael; Covas Planells, María Isabel; Fitó, Montserrat; Motilva Casado, Mª José; Solà, Rosa (Public Library Science, 2015-06-10)The effects of olive oil phenolic compounds (PCs) on HDL proteome, with respect to new aspects of cardioprotective properties, are still unknown. The aim of this study was to assess the impact on the HDL protein cargo of ...