PMID- 31842921
OWN - NLM
STAT- MEDLINE
DCOM- 20200601
LR  - 20220411
IS  - 1749-799X (Electronic)
IS  - 1749-799X (Linking)
VI  - 14
IP  - 1
DP  - 2019 Dec 16
TI  - 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.
PG  - 441
LID - 10.1186/s13018-019-1477-2 [doi]
LID - 441
AB  - 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.
FAU - Rodas, Gil
AU  - Rodas G
AD  - Medical Department, Football Club Barcelona, C/Aristides Maillol, s/n 08028, 
      Barcelona, Spain.
AD  - Medicine and Exercise Sport Unit, Hospital Clinic and Sand Joan de Deu, Barcelona 
      University, C/Villarroel 170, 08036, Barcelona, Spain.
FAU - Soler, Robert
AU  - Soler R
AD  - ITRT Institut Terapia Regenerativa Tissular Centro Medico Teknon, C/Vilana 12. 
      08022, Barcelona, Spain.
FAU - Balius, Ramon
AU  - Balius R
AD  - Consell Catala del'Esport, Unitat d'Esporti Salut Av Paisos Catalans, 40-48, 
      08950, Esplugues, Spain.
FAU - Alomar, Xavier
AU  - Alomar X
AD  - Diagnostico por la Imagen, Clinica Creu Blanca, Passeig de la Reina Elisenda de 
      Montcada, 17, 08034, Barcelona, Spain.
FAU - Peirau, Xavier
AU  - Peirau X
AD  - ITRT Institut Terapia Regenerativa Tissular Centro Medico Teknon, C/Vilana 12. 
      08022, Barcelona, Spain.
AD  - Institut Nacional d'Educacio Fisica de Catalunya (INEFC), Partida Caparrella s/n, 
      25192, Lleida, Lleida, Spain.
FAU - Alberca, Mercedes
AU  - Alberca M
AD  - Instituto de Biologia y Genetica Molecular (IBGM), Universidad Valladolid y CSIC 
      Edificio IBGM, C/ Sanz y Fores, s/n, 47003, Valladolid, Spain.
AD  - Red TerCel de Terapia Celular, Instituto de Salud Carlos III, Hospital Clinico 
      Universitario Virgen de la Arrixaca. Servicio de Hematologia. Edf. General, Ctra. 
      Madrid-Cartagena s/n, 30120, Murcia, Spain.
FAU - Sanchez, Ana
AU  - Sanchez A
AD  - Instituto de Biologia y Genetica Molecular (IBGM), Universidad Valladolid y CSIC 
      Edificio IBGM, C/ Sanz y Fores, s/n, 47003, Valladolid, Spain.
AD  - Red TerCel de Terapia Celular, Instituto de Salud Carlos III, Hospital Clinico 
      Universitario Virgen de la Arrixaca. Servicio de Hematologia. Edf. General, Ctra. 
      Madrid-Cartagena s/n, 30120, Murcia, Spain.
FAU - Sancho, Javier Garcia
AU  - Sancho JG
AD  - Instituto de Biologia y Genetica Molecular (IBGM), Universidad Valladolid y CSIC 
      Edificio IBGM, C/ Sanz y Fores, s/n, 47003, Valladolid, Spain.
AD  - Red TerCel de Terapia Celular, Instituto de Salud Carlos III, Hospital Clinico 
      Universitario Virgen de la Arrixaca. Servicio de Hematologia. Edf. General, Ctra. 
      Madrid-Cartagena s/n, 30120, Murcia, Spain.
FAU - Rodellar, Clementina
AU  - Rodellar C
AD  - LAGENBIO, Facultad de Veterinaria, Lab. Genetica Bioquimica. Facultad de 
      Veterinaria, Universidad de Zaragoza, C/Miguel Servet 177, 50013, Zaragoza, 
      Spain.
FAU - Romero, Antonio
AU  - Romero A
AD  - LAGENBIO, Facultad de Veterinaria, Lab. Genetica Bioquimica. Facultad de 
      Veterinaria, Universidad de Zaragoza, C/Miguel Servet 177, 50013, Zaragoza, 
      Spain.
FAU - Masci, Lorenzo
AU  - Masci L
AD  - Institute of Sport Exercise and Health, London, UK.
FAU - Orozco, Lluis
AU  - Orozco L
AD  - ITRT Institut Terapia Regenerativa Tissular Centro Medico Teknon, C/Vilana 12. 
      08022, Barcelona, Spain.
FAU - Maffulli, Nicola
AU  - Maffulli N
AUID- ORCID: 0000-0002-5327-3702
AD  - Department of Musculoskeletal Disorders, University of Salerno School of 
      Medicine, Surgery and Dentistry, Salerno, Italy. n.maffulli@qmul.ac.uk.
AD  - Centre for Sports and Exercise Medicine, Queen Mary University of London, London, 
      UK. n.maffulli@qmul.ac.uk.
AD  - School of Pharmacy and Bioengineering, Keele University School of Medicine, Stoke 
      on Trent, UK. n.maffulli@qmul.ac.uk.
LA  - eng
SI  - ClinicalTrials.gov/NCT03454737
GR  - ITRT.2018.23-B/CT/Institutde Terapia Regenerativa Tissular, Centro Medico Teknon/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20191216
PL  - England
TA  - J Orthop Surg Res
JT  - Journal of orthopaedic surgery and research
JID - 101265112
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Clinical Trials, Phase I as Topic/methods
MH  - Clinical Trials, Phase II as Topic/methods
MH  - Double-Blind Method
MH  - Humans
MH  - Magnetic Resonance Imaging
MH  - Male
MH  - Mesenchymal Stem Cell Transplantation/adverse effects/*methods
MH  - Mesenchymal Stem Cells/*cytology
MH  - Middle Aged
MH  - Pain Measurement/methods
MH  - *Patellar Ligament/diagnostic imaging
MH  - Patient Selection
MH  - Pilot Projects
MH  - Randomized Controlled Trials as Topic/methods
MH  - Research Design
MH  - Tendinopathy/diagnostic imaging/*therapy
MH  - Treatment Outcome
MH  - Ultrasonography
MH  - Young Adult
PMC - PMC6916077
OTO - NOTNLM
OT  - Tendinopathy; Mesenchymal stem cells; Platelet-rich plasma
COIS- The authors declare that they have no competing interests.
EDAT- 2019/12/18 06:00
MHDA- 2020/06/02 06:00
PMCR- 2019/12/16
CRDT- 2019/12/18 06:00
PHST- 2019/07/01 00:00 [received]
PHST- 2019/11/14 00:00 [accepted]
PHST- 2019/12/18 06:00 [entrez]
PHST- 2019/12/18 06:00 [pubmed]
PHST- 2020/06/02 06:00 [medline]
PHST- 2019/12/16 00:00 [pmc-release]
AID - 10.1186/s13018-019-1477-2 [pii]
AID - 1477 [pii]
AID - 10.1186/s13018-019-1477-2 [doi]
PST - epublish
SO  - J Orthop Surg Res. 2019 Dec 16;14(1):441. doi: 10.1186/s13018-019-1477-2.