Process Optimization and Efficacy Assessment of Standardized PRP for Tendinopathies in Sports Medicine: Retrospective Study of Clinical Files and GMP Manufacturing Records in a Swiss University Hospital.

Details

Ressource 1Request a copy Under indefinite embargo.
UNIL restricted access
State: Public
Version: author
License: CC BY 4.0
Serval ID
serval:BIB_E069875488C1
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Process Optimization and Efficacy Assessment of Standardized PRP for Tendinopathies in Sports Medicine: Retrospective Study of Clinical Files and GMP Manufacturing Records in a Swiss University Hospital.
Journal
Bioengineering
Author(s)
Sebbagh P., Hirt-Burri N., Scaletta C., Abdel-Sayed P., Raffoul W., Gremeaux V., Laurent A., Applegate L.A., Gremion G.
ISSN
2306-5354 (Print)
ISSN-L
2306-5354
Publication state
Published
Issued date
25/03/2023
Peer-reviewed
Oui
Volume
10
Number
4
Pages
409
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
Platelet-rich plasma (PRP) preparations have recently become widely available in sports medicine, facilitating their use in regenerative therapy for ligament and tendon affections. Quality-oriented regulatory constraints for PRP manufacturing and available clinical experiences have underlined the critical importance of process-based standardization, a pre-requisite for sound and homogeneous clinical efficacy evaluation. This retrospective study (2013-2020) considered the standardized GMP manufacturing and sports medicine-related clinical use of autologous PRP for tendinopathies at the Lausanne University Hospital (Lausanne, Switzerland). This study included 48 patients (18-86 years of age, with a mean age of 43.4 years, and various physical activity levels), and the related PRP manufacturing records indicated a platelet concentration factor most frequently in the range of 2.0-2.5. The clinical follow-up showed that 61% of the patients reported favorable efficacy outcomes (full return to activity, with pain disappearance) following a single ultrasound-guided autologous PRP injection, whereas 36% of the patients required two PRP injections. No significant relationship was found between platelet concentration factor values in PRP preparations and clinical efficacy endpoints of the intervention. The results were in line with published reports on tendinopathy management in sports medicine, wherein the efficacy of low-concentration orthobiologic interventions appears to be unrelated to sport activity levels or to patient age and gender. Overall, this study confirmed the effectiveness of standardized autologous PRP preparations for tendinopathies in sports medicine. The results were discussed in light of the critical importance of protocol standardization for both PRP manufacturing and clinical administration to reduce biological material variability (platelet concentrations) and to enhance the robustness of clinical interventions (comparability of efficacy/patient improvement).
Keywords
cell therapies, good manufacturing practices, musculoskeletal regenerative medicine, optimized manufacturing, orthobiologics, platelet-rich plasma, process standardization, sports medicine, tendinopathies, transfusion medicine
Pubmed
Web of science
Open Access
Yes
Create date
08/05/2023 13:12
Last modification date
19/07/2023 6:57
Usage data