Clinical Trial to assess the effect of plasma rich in growth factors in locomotor system pathology. Tendinopathies
Objectives
Clinical Trial to evaluate the potential anti-inflammatory effect, safety and efficacy of autologous Platelet-rich plasma and Leukocyte Poor (LP-PRP) treatment.
In previous studies, LP-PRP has shown anti-inflammatory and pain relief effects, which are attributed to growth factors contained in platelets such as TGF-. This effect was more apparent in surgical interventions on hands or feet and motivated preliminary studies in a large animal model to evaluate the anti-inflammatory activity of LP-PRP infiltrated in muscle, tendon and joint lesions. The good results obtained at ITRT in the veterinary clinic, together with the absence of complications, encouraged the development of a clinical trial in humans.
There is disparity of criteria in the medical community regarding the use of PRP in tendinopathies, which we understand is fundamentally conditioned by the error of assimilating all LP-PRP without differentiating their characteristics or underestimating the importance of administering repeated doses at certain intervals.
Methodology
Phase IIa, unicentric clinical trial in patients with tendinopathy. 13 patients had supraspinatus tendinopathy, 12 had patellar tendinopathy, 2 had Achilles tendinopathy and 4 had epicondylitis. Each pathological location requires a personalized approach, as well as different doses of PRP.
2 autologous LP-PRP infiltrations were administered at 15-day intervals around the affected tendon.
The degree of pain was assessed using the visual analogue scale for pain (VAS).
Results
Safety
PRP infiltration did not cause any complications or significant toxic effects in treated patients.
Efficacy
The treatment showed efficacy in peritendinous inflammations, even in cases that were refractory to other therapies.
The highest efficacy was reported in the most frequently affected tendons: supraspinatus shoulder tendon (12 out of 13 patients), patellar tendon (9 out of 12 patients), Achilles tendon (2 out of 2 patients) and 4 epicondylitis patients.
Conclusions
Peritendinous infiltration of autologous LP-PRP showed positive results.
The obtained data encouraged continuing the treatments and advancing knowledge by conducting, as far as possible, new comparative and randomized studies.
STUDY DESCRITPION
Unicentric study
Development phase: IIa
Status: completed
Sponsor: ITRT
CEIC: Centro Médico Teknon
Investigators: L Orozco, R Soler Rich, L Rodriguez
Scientific collaboration: E Anítua, M Sánchez, I Andia, X Albillos, J Azofra, J Ardèvol, G Rodas, L Til, J Pericàs, J Toneu, C Solano, J Pericàs, A Turmo, X Valle; F Vidal
Ayuda a la investigación: ITRT- Centro Médico Teknon; Banc de Sang i Teixits (BST)