Platelet rich plasma: hope or hype?

Yaman, Reena; Kinard, Theresa N.

doi:10.21037/aob-21-57

Cited by 7 publications

(7 citation statements)

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“…In particular, the high diversity observed in the domain of autologous PRP preparation and use may be partly attributed to the heterogeneity of clinical users (e.g., hospitals, private clinics and medical offices, and esthetic institutes) and manufacturing materials (i.e., commercial PRP kits) [ 27 , 44 ]. This in turn may potentially explain the highly contrasted clinical reports on orthobiologic intervention efficacy assessment, as clinical results are highly dependent on the therapeutic indication and on the PRP preparation/administration method [ 24 , 25 , 26 , 27 , 30 , 40 , 44 ]. In addition to the fragmented and inhomogeneous technical aspects of current autologous PRP preparation and use, the application of regulatory requirements is specific to member states in the European Union (EU), and several gray zones exist with regard to responsibility attribution [ 29 , 44 ].…”

Section: Discussionmentioning

confidence: 99%

“…Autologous PRP therapy for tendon affections requires a local ultrasound-guided injection of a processed blood extract, which has been obtained by minimal manipulation (e.g., differential centrifugation) from patients’ blood. Such extracts are composed of concentrated platelets in autologous plasma following the removal of erythrocytes and lymphocytes [ 28 , 29 , 30 ]. Standard native blood sample volumes to be drawn from patients for PRP therapies in sports medicine range from 20 mL to 40 mL, with average blood platelet counts of 200,000 ± 75,000 platelets/µL.…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2023

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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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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2023

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“…In practice, platelet concentration factors in PRP can vary from 2–12 times and some studies have even reported a 0.52 value from the baseline, even though evoking standardization methods [ 15 , 16 , 17 ]. It is not clear from available clinical studies that higher platelet doses or concentrations provide an increased clinical benefit [ 27 , 75 ].…”

Section: Discussionmentioning

confidence: 99%

“…In addition, the American Academy of Orthopaedic Surgeons has published a consensus paper aiming to improve and accelerate the clinical evaluation, clinical use, and multifactorial optimization of biological-based therapies for musculoskeletal diseases and affections [ 26 ]. From a therapeutic standpoint, PRP applications have frequently been used within tissues with low intrinsic healing potential and for indications such as tendinopathies, calcaneal and plantar fasciitis in the foot, muscle strains, ligament sprains, articular cartilage injuries and degeneration, or local preparation before hair transplants [ 7 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ].…”

Section: Introductionmentioning

confidence: 99%

Current Status of PRP Manufacturing Requirements & European Regulatory Frameworks: Practical Tools for the Appropriate Implementation of PRP Therapies in Musculoskeletal Regenerative Medicine

Sebbagh

Cannone²,

Gremion

et al. 2023

Bioengineering

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Providing accurate and up-to-date practical tools enabling oversight of platelet-rich plasma (PRP) legislation and of the appropriate standards to be implemented for its manufacture and use in Europe is a demanding task. This is due to rapid medico-technological advancements, slowness and disparity in legislation updates and enforcement between member states, and many reported gray-zone practices, notably for autologous PRP use. The levels of risk associated with blood manipulation processes generally dictate the manufacturing requirements for PRP preparations, which have gradually shifted toward good manufacturing practices (GMP) for standardization and overall quality enhancement. This work firstly outlines Western European and Swiss legislation for PRP products/preparations, providing key simplified information and recommendations for medical doctors seeking to implement this biological-based therapy for safe use in hospital settings, clinics, or private offices. This work secondly shows the importance of PRP-based product manufacturing standardization, which subsequently enables sound clinical evaluation of therapeutic interventions. Although the applicable legal bases provide guidelines for GMP manufacturing infrastructure and basic process design, paramount importance is set on the definition of workflows, technical specifications, and key parameters for PRP preparation and delivery. Overall, the development of simple and robust technologies and processes for PRP preparation is critical for guaranteeing the high therapeutic quality of the intervention, in collaboration with qualified GMP manufacturing platforms. Importantly, this work aims to serve as a practical tool for clinicians based in Western Europe who are willing to appropriately (i.e., administratively and technically) implement autologous PRP treatments in musculoskeletal regenerative medicine workflows, to ensure they make informed and optimal regulatory or process-based decisions.

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“…PRP has the capacity to bring greater concentrations of physiologically active growth factors and different proteins to wounded tissues, with the added benefits of simplicity, safety, efficacy, and continuous availability (13) . Since the plasma used in autologous transplantation treatment is the patient's own, there is no chance of sensitization, genetic manipulation or disease transmission (14) .…”

Section: Introductionmentioning

confidence: 99%

Potential Effect of Platelet Rich Plasma as a Promoter of Bone Healing in Obese Rats (Histological and Ultrastructural Study)

Labah

Wahba

2023

Egyptian Dental Journal

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The study aimed to examine the impact of platelet rich plasma (PRP) on the healing of a mandibular bone defect in obese rats. In this research, forty-eight adult male albino rats were divided into two equal groups; Group 1: were fed on standard diet. Group 2: were fed on high fat diet for four weeks for obesity inducing. A bone defect on the right side of mandible was created in each rat then all rats were subdivided into two equal subgroups. In subgroups 1.1 and 2.1, the bone defects were left without treating whereas in subgroups 1.2 and 2.2 the bone defects were filled with PRP. Two and four weeks postoperatively, six rats per group were euthanized and the samples were processed histological examination, X-ray elemental microanalysis and scanning electron microscopic examination. The results showed that rats received high fat diet and their bone defects left untreated revealed delayed bone healing and depicted significant decrease in bone calcium level in comparison with other subgroups. Interestingly, rats received high fat diet and their bone defects filled with platelet rich plasma revealed marked progress in bone healing and exhibited significant increase in bone calcium level in comparison with rats received high fat diet and with untreated bone defect. Conclusion: Obesity impaired the healing of mandibular bone defect. However, PRP has the ability to offset the negative effect of obesity and promote bone healing in obese rats. Therefore, it is highly recommended in obese individuals to fill the surgical bone defects with PRP.

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Platelet rich plasma: hope or hype?

Cited by 7 publications

References 0 publications

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

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

Current Status of PRP Manufacturing Requirements & European Regulatory Frameworks: Practical Tools for the Appropriate Implementation of PRP Therapies in Musculoskeletal Regenerative Medicine

Potential Effect of Platelet Rich Plasma as a Promoter of Bone Healing in Obese Rats (Histological and Ultrastructural Study)

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