Clinical Trial to assess the effect of growth factors rich plasma in locomotor system pathology. Osteoarthritis
Objectives
Study 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.
Methodology
Phase IIa, unicentric clinical trial in patients with osteoarthritis.
79 patients with osteoarthritis grade II-IV were treated. 4 intra-articular infiltrations of autologous LP-PRP were applied at 15-day intervals.
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
In advanced knee osteoarthritis, pain and inflammation decreased significantly in more than 82% of cases.
Conclusions
Intra-articular 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 DESCRIPTION
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, Til, J Pericàs, J Toneu, C Solano, J Pericàs, A Turmo, X Valle; F Vidal
Participating entities: ITRT- Centro Médico Teknon; Banc de Sang i Teixits (BST)