A Simple Double-Spin Closed Method for Preparing Platelet-Rich Plasma

Machado, Edilson Silva; Soares, Fabiano P; Yamaguchi, Roberta S; Felipone, William K; Meves, Robert; Souza, Tais Amara C; Topolniak, Roberto; Caldas, José P; Abreu, Ernani V; Neto, Luiz S Rabelo; Pinchemel, Pedro Vinicius S; Bredemeier, Markus

doi:10.7759/cureus.20899

Cited by 7 publications

(6 citation statements)

References 25 publications

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“…The PRP used had an average concentration of 5x (Harvest Technologies Corporation Plymouth, MA centrifuge). This historical series was recently compared with another series of patients from the same team who used an ultraconcentrated Leukocyte Rich PRP (LR PRP) with an average of 10x more platelets than the baseline level [31]. The improvement in pain in the historical series was 1.7 (p=0.063) and in disability was 33.7±12.3 (p=0.001).…”

Section: Discussionmentioning

confidence: 99%

“…Study design: This is a prospective case series study presenting the clinical results of the patients treated with PRP injections performed following the Multi Target clinical protocol and the Simple Double Spin PRP method described elsewere [23]. This study composes the second part of the feasibility study of a randomized controlled trial project named 'Biologic Therapy for Low Back Pain', and follow the guidelines of the Biological Treatments Working Group of the American Academy of Orthopedics (www.mibo-statement.org) and the Standard Protocol Items Recommendations for Interventional Trials -SPIRIT Checklist [24,25].…”

Section: Methodsmentioning

confidence: 99%

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A Regenerative Interventional Approach to the Management of Degenerative Low Back Pain

Machado¹

2022

JRMBR

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Objective: Low back pain has been strongly related to the degenerative process of the spine, especially the degeneration of the intervertebral disc and facet joints. The main procedures for the management of low back pain are no intended to slow down or reverse the degenerative process. Platelet Rich Plasma (PRP), an orthobiologic product, has been the subject of several studies in the management of low back pain. Methods: A prospective case series study presenting the clinical results of 23 patients treated with PRP injections performed following clinical a interventionist protocol called PerMuTIS – Personalized Multi Target Biologic Injection of the Spine. The method to obtain the platelet concentrate was the Simple Double Spin technique, a low-cost double spin that produces Leucocyte Rich PRP. Baseline scores of pain and disability using the Visual Analog Scale (VAS) and Roland-Morris Disability Questionnaire (RMDQ) were recorded. Results: Mean VAS pain score across the cohort decreased by approximately 62%, while the Roland-Morris disability score decreased by about 60% at 52 weeks. There was no report of adverse events. The Leucocite and Monocite Rich PRP product showed concentration of 4.3X above baseline, with monocites concentration of 3.2X baseline. Conclusion: The concept of application in multiple targets using a simple and low-cost preparation technique proved to be feasible and without reports of serious side effects that compromise its indication. The PerMuTIS – Personalized Multi Target Biologic Injection in the Spine Technique using Simple Double Spin protocol demonstrated safety and feasibility in this prospective study of patients with low back pain who failed conservative treatments. Large scale, multicenter randomized clinical trial will provide an appropriate level of evidence to assist in clinical practice.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

A Regenerative Interventional Approach to the Management of Degenerative Low Back Pain

Machado¹

2022

JRMBR

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“…Clinical use of leukocyte-rich PRP (L-PRP) is often associated with increased pain, swelling, and inflammation in the treated area [22]. Despite challenges in eliminating leukocytes through a simple centrifugation procedure, several PRP preparations opt for a second centrifugation to minimize leukocyte content and further concentrate platelets [23,24]. These trends point towards a preference for leukocyte depletion in PRP preparation protocols.…”

Section: Leukocyte Content Of Platelet-rich Plasmasmentioning

confidence: 99%

Not all platelet-rich plasma are created equal

Cantero

2024

Current Opinion in Obstetrics &Amp; Gynecology

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Purpose of review This review aims to elucidate potential variations in clinical outcomes resulting from the use of different types of platelet-rich plasma (PRPs) in reproductive medicine. It seeks to explore the reasons behind the diverse results reported in various studies and assess the general features distinguishing different PRP formulations. Recent findings PRPs have found applications across diverse medical fields, generating controversy due to the variability in outcomes. The field of reproductive medicine, despite its limited published studies, is encountering a similar challenge as it integrates these treatments. Summary The multitude of PRP product brands in the market, coupled with ‘home-made’ PRPs, poses a significant barrier to establishing a common protocol for the preparation of standardized PRP products. This impediment hinders widespread adoption by clinicians, particularly in endometrial or ovarian treatments. Drawing from evidence in other medical disciplines, this review endeavors to compile essential characteristics that PRPs must possess, aiming to mitigate the impact of variables affecting results in forthcom ing studies.

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“…Autologous PRP products are complex and naturally variable in their composition and the need for thorough quality controls in view of clinical applications makes it crucial to demonstrate consistency in the manufacturing process [ 4 , 15 , 51 , 52 ]. General protocols for PRP preparation consist of blood collection and a first centrifugation step to separate the red blood cells (RBC), which is then followed by a subsequent second centrifugation step to concentrate the platelets and other components and to provide activation of the biological product (i.e., mechanical action of injection, Figure S2 ) [ 61 , 62 , 63 , 64 , 65 , 66 ].…”

Section: Importance Of Manufacturing Process Standardization For Ther...mentioning

confidence: 99%

“…The main parameters that may be optimized comprise the type of medical devices chosen for blood draw, variation of the relative centrifugal force, as well as temperature and time brackets for platelet isolation ( Table 3 ) [ 16 , 59 , 62 , 66 ]. Even though commercially marketed PRP kits offer the possibility of rapid obtention of ready-to-use PRP suspensions, which should be sterile, several disadvantages have been identified [ 16 , 59 ].…”

Section: Importance Of Manufacturing Process Standardization For Ther...mentioning

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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A Simple Double-Spin Closed Method for Preparing Platelet-Rich Plasma

Cited by 7 publications

References 25 publications

A Regenerative Interventional Approach to the Management of Degenerative Low Back Pain

A Regenerative Interventional Approach to the Management of Degenerative Low Back Pain

Not all platelet-rich plasma are created equal

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

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