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  4. 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
 
research article

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

Sebbagh, Patrick
•
Hirt-Burri, Nathalie
•
Scaletta, Corinne
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April 1, 2023
Bioengineering-Basel

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).

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Type
research article
DOI
10.3390/bioengineering10040409
Web of Science ID

WOS:000979264900001

Author(s)
Sebbagh, Patrick
Hirt-Burri, Nathalie
Scaletta, Corinne
Abdel-Sayed, Philippe  
Raffoul, Wassim
Gremeaux, Vincent
Laurent, Alexis
Applegate, Lee Ann
Gremion, Gerald
Date Issued

2023-04-01

Publisher

MDPI

Published in
Bioengineering-Basel
Volume

10

Issue

4

Start page

409

Subjects

Biotechnology & Applied Microbiology

•

Engineering, Biomedical

•

Biotechnology & Applied Microbiology

•

Engineering

•

cell therapies

•

good manufacturing practices

•

musculoskeletal regenerative medicine

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optimized manufacturing

•

orthobiologics

•

platelet-rich plasma

•

process standardization

•

sports medicine

•

tendinopathies

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transfusion medicine

Editorial or Peer reviewed

REVIEWED

Written at

EPFL

Available on Infoscience
May 22, 2023
Use this identifier to reference this record
https://infoscience.epfl.ch/handle/20.500.14299/197753
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