Treatment of Refractory Patellar Tendinopathy With Mesenquimal Trunk Cells. Comparative Study With PRP. (TENDO)
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|ClinicalTrials.gov Identifier: NCT03454737|
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : August 8, 2018
This is a clinical trial, unicentric, prospective, controlled, randomized, double blind during the experimental phase A.
In the experimental phase B, it is contemplated to administer the experimental treatment to the subjects included in the group treated with P-PRP in the event that the first treatment would be significantly more effective, both from a clinical and regenerative point of view
|Condition or disease||Intervention/treatment||Phase|
|Patellar Tendinopathy||Procedure: mesenchymal stem cells Procedure: Pure platelet-rich plasma||Not Applicable|
- Confirm the presence of patellar tendon gap regeneration after the peritendinous and intratendinous infusion of MSV and compare it with the P-PRP group, evaluated by ECO, NMR and UTC.
- To evaluate the clinical efficacy of infusion of MSC in refractory patellar tendinopathy compared with the P-PRP group through the subjective clinical evolution of the patient, the EVA and VISA-P questionnaires and the strength of the extensor muscle group measured by dynamometry.
- Secondary objective 1. To evaluate the feasibility and safety of the advanced therapy medication MSV and P-PRP when applied by percutaneous infusion into the body of the patellar tendinosis, verifying that each of the procedures established in the protocol is feasible and recording the possible adverse effects related with both treatments and adverse events arising during the period of the clinical trial, whether or not related to it
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Treatment of Refractory Patellar Tendinopathy With Mesenquimal Trunk Cells. Comparative Study With PRP.|
|Actual Study Start Date :||December 13, 2017|
|Estimated Primary Completion Date :||June 20, 2019|
|Estimated Study Completion Date :||December 14, 2020|
|Experimental: mesenchymal stem cells||
Procedure: mesenchymal stem cells
Autologous bone marrow aspiration is used as a cellular source to obtain MSVs and is subjected to the protocolized anticoagulant procedure. After checking the perfect condition of the shipment and the correct completion of the documentation that accompanies it, the processing of the bone marrow will be carried out.
The processing of the bone marrow will be done in the Cell Therapy Unit of the IBGM under NCF, within 24 hours of the completion of the aspiration
|Active Comparator: Pure platelet-rich plasma||
Procedure: Pure platelet-rich plasma
Under aseptic conditions, in surgical medium, 6 ml of P-PRP will be obtained from 36 ml of autologous peripheral venous blood sample.
The plasma coagulation will be activated by the addition of Cl2Ca at a concentration of 5%.
- Improvement in the tendon ecotexture [ Time Frame: 24 months ]The patellar tendon will be examined longitudinally and transversely using gray scale and color, exerting a minimum pressure with the probe. Images will be recorded in static and dynamic formats to develop a consensus of the findings.
- Presence of patellar tendon regeneration by the peritendinous and intratendinous infusion of MSV patellar tendinopathy compared to the P-PRP group [ Time Frame: 24 months ]Using ECO, RMN and UTC (Ultrasound Tissue Characterisation)
- the strength of the extensor muscle group [ Time Frame: 24 months ]using dynamometry.
- subjective clinical evolution of the patient [ Time Frame: 24 months ]Using EVA and VISA-P (Victorian Institute of Sport Assessment (patelar)) questionnaries.
- strength of the extensor muscle group [ Time Frame: 24 months ]Using dynamometry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454737
|Contact: Gil Rodas, MD||+34 firstname.lastname@example.org|
|Contact: Carme Barberoemail@example.com|
|Institut de Terapia Regenerativa Tissular||Recruiting|
|Barcelona, Spain, 08022|
|Contact: Gil Rodas, MD +34 932906042 firstname.lastname@example.org|
|Contact: Carme Barbero +34 932906042 email@example.com|
|Principal Investigator:||Gil Rodas, MD||Centro Médico Teknon|