Treatment of refractory patellar tendinopathy with MSV*. Comparative study with LP-PRP (TENDO)

ClinicalTrials.gov Identifier: NCT03454737
Nº EudraCT: 2016-001262-28

Objectives

Confirm the presence of patellar tendon GAP regeneration after the peritendinous infusion of MSV and compare it with the group of LP-PRP (Platelet-rich plasma and leukocyte-poor).

The research has two objectives. First, to determine if there is clinical improvement after treatment by assessing pain with two procedures, the visual analogue scale (VAS) and the proposed evaluation by the Victorian Institute of Sport Assessment for the patellar tendon (VISA-P), and strength using dynamometry.
The second, to determine the presence of patellar tendon regeneration by means of different imaging techniques: ECO, ECO Doppler, Ultrasound Tissue Characterization (UTC) and magnetic resonance imaging with ultrashort echo time (MRI-UTE). With the last two techniques, tissue regeneration can be quantified by visualizing structural defects and quantifying the alignment of collagen fibres that would not be possible with conventional images.

Methodology

Phase II, comparative, randomized and double-blind clinical trial. 20 pacientes diagnosed with patellar tendinopathy and signs of rupture in the proximal pole of the patellar tendon showing clinical pain and functional disability over more than 6 months are included.

10 randomized patients are treated with MSV and 10 randomized patients (control group) with P-PRP, intra and peritendinous, by ECO and under sedation.

The results will be evaluated at 6 months after treatment. If results support the hypothesis that a greater efficacy is obtained with expanded mesenchymal cells, this autologous treatment will be offered to those patients in the LP-PRP group who still maintain the GAP. All of them will be monitored over 1 and 2 years.


STUDY DESCRIPTION

Unicentric study
Development phase: II, controlled, randomized, double-blind
Status: ongoing
PEI: 10-134
Nº Eudra-CT: 2016-001262-28
Code: MSC-TENDO-2015
ClinicalTrials.gov: NCT03454737
Sponsor: ITRT
CEIm: Grupo Hospitalario Quirónsalud-Barcelona
Control: Spanish Medicine Agency (AEMPS)
Investigators: G Rodas, R Soler, L Orozco, X Peirau, A Munar, R Balius, A Sánchez, M Alberca, V García, J García Sancho, Á Ruiz, A Romero, C Rodellar, JC Vilanova, X Alomar
Participating entities: ITRT, Centro Médico Teknon; Teknon Foundation; Servicios Médicos del Fútbol Club Barcelona; LAGENBIO (Universidad de Zaragoza); IBGM (Universidad de Valladolid); Departamento de Resonancia Magnética de Clínica Girona; Departamento de Diagnóstico por la Imagen de Clínica Creu Blanca; Clínica MAPFRE de Medicina del Tenis.

ECO: ultrasound; VAS: visual analogue scale for pain; MSV: autologous mesenchymal stem cells from bone marrow; LP-PRP: platelet-rich plasma and leukocyte-poor; VISA-P: Victorian Institute of Sports Assessment –Patellar questionnaire; MRI: nuclear magnetic resonance; UTC: ultrasound tissue characterization.

*MSV are autologous, bone marrow mesenchymal stem cells, selected and cultivated under the Correct Manufacturing Standards of the Institute of Molecular Biology and Genetics (University of Valladolid and CSIC).