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

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2019Author
Rodas, Gil
Soler, Robert
Balius, Ramón
Alomar, Xavier
Alberca, Mercedes
Sánchez, Ana
García Sancho, Javier
Rodellar, Clementina
Romero, Antonio
Masci, Lorenzo
Orozco, Lluís
Maffulli, Nicola
Suggested citation
Rodas, Gil;
Soler, Robert;
Balius, Ramón;
Alomar, Xavier;
Peirau i Terés, Xavier;
Alberca, Mercedes;
...
Maffulli, Nicola.
(2019)
.
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.
Journal of Orthopaedic Surgery and Research, 2019, vol. 14, article441.
https://doi.org/10.1186/s13018-019-1477-2.
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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.
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Journal of Orthopaedic Surgery and Research, 2019, vol. 14, article441European research projects
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