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Clinical Trial Summary

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


Clinical Trial Description

- Main objective

1. 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.

2. 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 Design


Related Conditions & MeSH terms


NCT number NCT03454737
Study type Interventional
Source Institut de Terapia Regenerativa Tissular
Contact
Status Active, not recruiting
Phase N/A
Start date December 13, 2017
Completion date December 14, 2020

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