Standardized management of platelet derivatives for tissue regeneration research and applications_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

XIE Xingqin ^1,2 ,  ZHANG Yi ^1,2 , ZHAO Xinxin ² , LIU Tongxin ² , SUN Liping ³

1. National and Local Joint Stem Cell Research and Engineering Center for Aging Diseases, Harbin Heilongjiang, 150028, P.R.China;
2. R&D Center, Tian Qing Stem Cell Co., Ltd., Harbin Heilongjiang, 150028, P.R.China;
3. Department of Obstetrics and Gynecology, Qiqihar Jianhua Hospital, Qiqihar Heilongjiang, 161006, P.R.China;

Corresponding?author：

ZHANG Yi, Email: neo_yi_zhang@163.com

Keywords：

Platelet derivatives; platelet-rich plasma; platelet rich fibrin; platelet lysates; standardization; quality control

DOI：

10.7507/1002-1892.202011023

Video：

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Objective To summary the standardized management in research and applications of platelet derivatives for tissue regeneration.Methods The related literature about bottlenecks and standardized management of platelet derivatives in recent years was reviewed and analyzed.Results Although the platelet derivatives are increasingly used to accelerate the regenerative processes of injured joint, skin, nerve, ligament/tendon, and alveolar bone, etc., the large variation in preparation methods, diverse nomenclature, incomplete reporting system, and lack of quantitative and standardized management of the preparation process have caused uncertainty and incomparability of research and application results. In recent years, there has been a trend towards standardized research and management of platelet derivatives.Conclusion The implementation of standardized research and quality management will contribute to promote the research and application of platelet derivatives in the field of tissue regeneration.

Citation： XIE Xingqin, ZHANG Yi, ZHAO Xinxin, LIU Tongxin, SUN Liping. Standardized management of platelet derivatives for tissue regeneration research and applications. Chinese Journal of Reparative and Reconstructive Surgery, 2021, 35(3): 392-398. doi: 10.7507/1002-1892.202011023 Copy

1.	Burkhart JM, Vaudel M, Gambaryan S, et al. The first comprehensive and quantitative analysis of human platelet protein composition allows the comparative analysis of structural and functional pathways. Blood, 2012, 120(15): e73-82.
2.	Lee HW, Choi KH, Kim JY, et al. Proteomic classification and identification of proteins related to tissue healing of platelet-rich plasma. Clin Orthop Surg, 2020, 12(1): 120-129.
3.	Le ADK, Enweze L, DeBaun MR, et al. Current clinical recommendations for use of platelet-rich plasma. Curr Rev Musculoskelet Med, 2018, 11(4): 624-634.
4.	Acebes-Huerta A, Arias-Fernández T, Bernardo á, et al. Platelet-derived bio-products: Classification update, applications, concerns and new perspectives. Transfus Apher Sci, 2020, 59(1): 102716.
5.	Agrawal AA. Evolution, current status and advances in application of platelet concentrate in periodontics and implantology. World J Clin Cases, 2017, 5(5): 159-171.
6.	Zamani M, Yaghoubi Y, Movassaghpour A, et al. Novel therapeutic approaches in utilizing platelet lysate in regenerative medicine: Are we ready for clinical use? J Cell Physiol, 2019, 234(10): 17172-17186.
7.	Hausauer AK, Humphrey S. The physician’s guide to platelet-rich plasma in dermatologic surgery part Ⅱ: Clinical evidence. Dermatol Surg, 2020, 46(4): 447-456.
8.	中國醫療保健國際交流促進會骨科分會. 關節腔注射富血小板血漿治療膝骨關節炎的臨床實踐指南 (2018 年版). 中華關節外科雜志 (電子版), 2018, 12(4): 444-448.
9.	Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol, 2009, 27(3): 158-167.
10.	DeLong JM, Russell RP, Mazzocca AD. Platelet-rich plasma: the PAW classification system. Arthroscopy, 2012, 28(7): 998-1009.
11.	Mautner K, Malanga GA, Smith J, et al. A call for a standard classification system for future biologic research: the rationale for new PRP nomenclature. PM R, 2015, 7(4 Suppl): S53-S59.
12.	Magalon J, Chateau AL, Bertrand B, et al. DEPA classification: a proposal for standardising PRP use and a retrospective application of available devices. BMJ Open Sport Exerc Med, 2016, 2(1): e000060.
13.	Lana JFSD, Purita J, Paulus C, et al. Contributions for classification of platelet rich plasma-proposal of a new classification: MARSPILL. Regen Med, 2017, 12(5): 565-574.
14.	Rossi LA, Murray IR, Chu CR, et al. Classification systems for platelet-rich plasma. Bone Joint J, 2019, 101-B(8): 891-896.
15.	Fujioka-Kobayashi M, Miron RJ, Hernandez M, et al. Optimized platelet-rich fibrin with the low-speed concept: Growth factor release, biocompatibility, and cellular response. J Periodontol, 2017, 88(1): 112-121.
16.	Al-Ajlouni J, Awidi A, Samara O, et al. Safety and efficacy of autologous intra-articular platelet lysates in early and intermediate knee osteoarthrosis in humans: A prospective open-label study. Clin J Sport Med, 2015, 25(6): 524-528.
17.	Labibzadeh N, Emadedin M, Fazeli R, et al. Mesenchymal stromal cells implantation in combination with platelet lysate product is safe for reconstruction of human long bone nonunion. Cell J Fall, 2016, 18(3): 302-309.
18.	Robinson ST, Douglas AM, Chadid T, et al. A novel platelet lysate hydrogel for endothelial cell and mesenchymal stem cell-directed neovascularization. Acta Biomater, 2016, 36: 86-98.
19.	劉春香, 王博昊, 張怡. 超活化富血小板裂解液的制備及其對雄激素性脫發小鼠模型毛囊再生作用. 國際生物制品學雜志, 2020, 43(1): 16-19.
20.	Naskou MC, Sumner S, Berezny A, et al. Fibrinogen-depleted equine platelet lysate affects the characteristics and functionality of mesenchymal stem cells. Stem Cells Dev, 2019, 28(23): 1572-1580.
21.	Chahla J, Cinque ME, Piuzzi NS, et al. A call for standardization in platelet-rich plasma preparation protocols and composition reporting: A systematic review of the clinical orthopaedic literature. J Bone Joint Surg (Am), 2017, 99(20): 1769-1779.
22.	Fadadu PP, Mazzola AJ, Hunter CW, et al. Review of concentration yields in commercially available platelet-rich plasma (PRP) systems: a call for PRP standardization. Reg Anesth Pain Med, 2019, 44: 652-659.
23.	De Pascale MR, Sommese L, Casamassimi A, et al. Platelet derivatives in regenerative medicine: an update. Transfus Med Rev, 2015, 29(1): 52-61.
24.	Callan MB, Shofer FS, Catalfamo JL. Effects of anticoagulant on pH, ionized calcium concentration, and agonist-induced platelet aggregation in canine platelet-rich plasma. Am J Vet Res, 2009, 70(4): 472-477.
25.	Isobe K, Watanebe T, Kawabata H, et al. Mechanical and degradation properties of advanced platelet-rich fibrin (A-PRF), concentrated growth factors (CGF), and platelet-poorplasma-derived fibrin (PPTF). Int J Implant Dent, 2017, 3(1): 17.
26.	Ozer K, Kankaya Y, Colak O, et al. The impact of duration and force of centrifugation on platelet content and mass in the preparation of platelet-rich plasma. Aesthetic Plast Surg, 2019, 43(4): 1078-1084.
27.	呂汝舉, 田舉, 朱江婷, 等. 富血小板血漿設備的設計和應用//張長青, 程飚. 富血小板血漿技術在臨床的應用. 上海: 上海交通大學出版社, 2018: 37-42.
28.	Rebulla P, Pupella S, Santodirocco M, et al. Multicentre standardisation of a clinical grade procedure for the preparation of allogeneic platelet concentrates from umbilical cord blood. Blood Transfus, 2016, 14(1): 73-79.
29.	van der Meer PF, Seghatchian J, Marks DC. Quality standards, safety and efficacy of blood-derived serum eye drops: A review. Transfus Apher Sci, 2016, 54(1): 164-167.
30.	Viau S, Lagrange A, Chabrand L, et al. A highly standardized and characterized human platelet lysate for efficient and reproducible expansion of human bone marrow mesenchymal stromal cells. Cytotherapy, 2019, 21(7): 738-754.
31.	Seghatchian J, Espinosa A, Burnouf T. Quality, safety and sustained therapeutic efficacy of blood-derived serum eye drops to treat dry eye syndrome: R& D road map for future progress. Transfus Apher Sci, 2016, 54(1): 168-169.
32.	Strunk D, Lozano M, Marks DC, et al. International Forum on GMP-grade human platelet lysate for cell propagation: summary. Vox Sang, 2018, 113(1): 80-87.
33.	Schallmoser K, Henschler R, Gabriel C, et al. Production and quality requirements of human platelet lysate: A position statement from the working party on cellular therapies of the international society of blood transfusion. Trends Biotechnol, 2020, 38(1): 13-23.
34.	International Cellular Medical Society. Best Practices Standards in Cell Based Medicine, Section Ⅷ-Platelet Rich Plasma (PRP) Guidelines [EB/OL]. http://www.cellmedicinesociety.org/attachments/370_Section%2010%20-%20Platelet%20Rich%20Plasma%20(PRP)%20Guidelines.pdf, 2011.
35.	中國醫療保健國際交流促進會骨科分會. 富血小板血漿在骨關節外科臨床應用專家共識 (2018 年版). 中華關節外科雜志 (電子版), 2018, 12(5): 596-600.
36.	Beitzel K, Allen D, Apostolakos J, et al. US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine. J Knee Surg, 2015, 28(1): 29-34.
37.	Fiorentino S, Roffi A, Filardo G, et al. European definitions, current use, and EMA stance of platelet-rich plasma in sports medicine. J Knee Surg, 2015, 28(1): 51-54.
38.	Anitua E, Prado R, Orive G. A new regulatory framework forplatelet-rich plasma in spain. J Knee Surg, 2015, 28(4): 355-356.
39.	Anitua E, Prado R, Orive G. A new regulatory framework for platelet-rich plasma in spain. J Knee Surg, 2015, 28(4): 355-356.
40.	Anitua E, Prado R, Orive G. Closing regulatory gaps: new ground rules for platelet-rich plasma. Trends Biotechnol, 2015, 33(9): 492-495.
41.	Kawase T, Okuda K. Comprehensive quality control of the regenerative therapy using platelet concentrates: The current situation and prospects in Japan. Biomed Res Int, 2018, 2018: 6389157.

1. Burkhart JM, Vaudel M, Gambaryan S, et al. The first comprehensive and quantitative analysis of human platelet protein composition allows the comparative analysis of structural and functional pathways. Blood, 2012, 120(15): e73-82.
2. Lee HW, Choi KH, Kim JY, et al. Proteomic classification and identification of proteins related to tissue healing of platelet-rich plasma. Clin Orthop Surg, 2020, 12(1): 120-129.
3. Le ADK, Enweze L, DeBaun MR, et al. Current clinical recommendations for use of platelet-rich plasma. Curr Rev Musculoskelet Med, 2018, 11(4): 624-634.
4. Acebes-Huerta A, Arias-Fernández T, Bernardo á, et al. Platelet-derived bio-products: Classification update, applications, concerns and new perspectives. Transfus Apher Sci, 2020, 59(1): 102716.
5. Agrawal AA. Evolution, current status and advances in application of platelet concentrate in periodontics and implantology. World J Clin Cases, 2017, 5(5): 159-171.
6. Zamani M, Yaghoubi Y, Movassaghpour A, et al. Novel therapeutic approaches in utilizing platelet lysate in regenerative medicine: Are we ready for clinical use? J Cell Physiol, 2019, 234(10): 17172-17186.
7. Hausauer AK, Humphrey S. The physician’s guide to platelet-rich plasma in dermatologic surgery part Ⅱ: Clinical evidence. Dermatol Surg, 2020, 46(4): 447-456.
8. 中國醫療保健國際交流促進會骨科分會. 關節腔注射富血小板血漿治療膝骨關節炎的臨床實踐指南 (2018 年版). 中華關節外科雜志 (電子版), 2018, 12(4): 444-448.
9. Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol, 2009, 27(3): 158-167.
10. DeLong JM, Russell RP, Mazzocca AD. Platelet-rich plasma: the PAW classification system. Arthroscopy, 2012, 28(7): 998-1009.
11. Mautner K, Malanga GA, Smith J, et al. A call for a standard classification system for future biologic research: the rationale for new PRP nomenclature. PM R, 2015, 7(4 Suppl): S53-S59.
12. Magalon J, Chateau AL, Bertrand B, et al. DEPA classification: a proposal for standardising PRP use and a retrospective application of available devices. BMJ Open Sport Exerc Med, 2016, 2(1): e000060.
13. Lana JFSD, Purita J, Paulus C, et al. Contributions for classification of platelet rich plasma-proposal of a new classification: MARSPILL. Regen Med, 2017, 12(5): 565-574.
14. Rossi LA, Murray IR, Chu CR, et al. Classification systems for platelet-rich plasma. Bone Joint J, 2019, 101-B(8): 891-896.
15. Fujioka-Kobayashi M, Miron RJ, Hernandez M, et al. Optimized platelet-rich fibrin with the low-speed concept: Growth factor release, biocompatibility, and cellular response. J Periodontol, 2017, 88(1): 112-121.
16. Al-Ajlouni J, Awidi A, Samara O, et al. Safety and efficacy of autologous intra-articular platelet lysates in early and intermediate knee osteoarthrosis in humans: A prospective open-label study. Clin J Sport Med, 2015, 25(6): 524-528.
17. Labibzadeh N, Emadedin M, Fazeli R, et al. Mesenchymal stromal cells implantation in combination with platelet lysate product is safe for reconstruction of human long bone nonunion. Cell J Fall, 2016, 18(3): 302-309.
18. Robinson ST, Douglas AM, Chadid T, et al. A novel platelet lysate hydrogel for endothelial cell and mesenchymal stem cell-directed neovascularization. Acta Biomater, 2016, 36: 86-98.
19. 劉春香, 王博昊, 張怡. 超活化富血小板裂解液的制備及其對雄激素性脫發小鼠模型毛囊再生作用. 國際生物制品學雜志, 2020, 43(1): 16-19.
20. Naskou MC, Sumner S, Berezny A, et al. Fibrinogen-depleted equine platelet lysate affects the characteristics and functionality of mesenchymal stem cells. Stem Cells Dev, 2019, 28(23): 1572-1580.
21. Chahla J, Cinque ME, Piuzzi NS, et al. A call for standardization in platelet-rich plasma preparation protocols and composition reporting: A systematic review of the clinical orthopaedic literature. J Bone Joint Surg (Am), 2017, 99(20): 1769-1779.
22. Fadadu PP, Mazzola AJ, Hunter CW, et al. Review of concentration yields in commercially available platelet-rich plasma (PRP) systems: a call for PRP standardization. Reg Anesth Pain Med, 2019, 44: 652-659.
23. De Pascale MR, Sommese L, Casamassimi A, et al. Platelet derivatives in regenerative medicine: an update. Transfus Med Rev, 2015, 29(1): 52-61.
24. Callan MB, Shofer FS, Catalfamo JL. Effects of anticoagulant on pH, ionized calcium concentration, and agonist-induced platelet aggregation in canine platelet-rich plasma. Am J Vet Res, 2009, 70(4): 472-477.
25. Isobe K, Watanebe T, Kawabata H, et al. Mechanical and degradation properties of advanced platelet-rich fibrin (A-PRF), concentrated growth factors (CGF), and platelet-poorplasma-derived fibrin (PPTF). Int J Implant Dent, 2017, 3(1): 17.
26. Ozer K, Kankaya Y, Colak O, et al. The impact of duration and force of centrifugation on platelet content and mass in the preparation of platelet-rich plasma. Aesthetic Plast Surg, 2019, 43(4): 1078-1084.
27. 呂汝舉, 田舉, 朱江婷, 等. 富血小板血漿設備的設計和應用//張長青, 程飚. 富血小板血漿技術在臨床的應用. 上海: 上海交通大學出版社, 2018: 37-42.
28. Rebulla P, Pupella S, Santodirocco M, et al. Multicentre standardisation of a clinical grade procedure for the preparation of allogeneic platelet concentrates from umbilical cord blood. Blood Transfus, 2016, 14(1): 73-79.
29. van der Meer PF, Seghatchian J, Marks DC. Quality standards, safety and efficacy of blood-derived serum eye drops: A review. Transfus Apher Sci, 2016, 54(1): 164-167.
30. Viau S, Lagrange A, Chabrand L, et al. A highly standardized and characterized human platelet lysate for efficient and reproducible expansion of human bone marrow mesenchymal stromal cells. Cytotherapy, 2019, 21(7): 738-754.
31. Seghatchian J, Espinosa A, Burnouf T. Quality, safety and sustained therapeutic efficacy of blood-derived serum eye drops to treat dry eye syndrome: R& D road map for future progress. Transfus Apher Sci, 2016, 54(1): 168-169.
32. Strunk D, Lozano M, Marks DC, et al. International Forum on GMP-grade human platelet lysate for cell propagation: summary. Vox Sang, 2018, 113(1): 80-87.
33. Schallmoser K, Henschler R, Gabriel C, et al. Production and quality requirements of human platelet lysate: A position statement from the working party on cellular therapies of the international society of blood transfusion. Trends Biotechnol, 2020, 38(1): 13-23.
34. International Cellular Medical Society. Best Practices Standards in Cell Based Medicine, Section Ⅷ-Platelet Rich Plasma (PRP) Guidelines [EB/OL]. http://www.cellmedicinesociety.org/attachments/370_Section%2010%20-%20Platelet%20Rich%20Plasma%20(PRP)%20Guidelines.pdf, 2011.
35. 中國醫療保健國際交流促進會骨科分會. 富血小板血漿在骨關節外科臨床應用專家共識 (2018 年版). 中華關節外科雜志 (電子版), 2018, 12(5): 596-600.
36. Beitzel K, Allen D, Apostolakos J, et al. US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine. J Knee Surg, 2015, 28(1): 29-34.
37. Fiorentino S, Roffi A, Filardo G, et al. European definitions, current use, and EMA stance of platelet-rich plasma in sports medicine. J Knee Surg, 2015, 28(1): 51-54.
38. Anitua E, Prado R, Orive G. A new regulatory framework forplatelet-rich plasma in spain. J Knee Surg, 2015, 28(4): 355-356.
39. Anitua E, Prado R, Orive G. A new regulatory framework for platelet-rich plasma in spain. J Knee Surg, 2015, 28(4): 355-356.
40. Anitua E, Prado R, Orive G. Closing regulatory gaps: new ground rules for platelet-rich plasma. Trends Biotechnol, 2015, 33(9): 492-495.
41. Kawase T, Okuda K. Comprehensive quality control of the regenerative therapy using platelet concentrates: The current situation and prospects in Japan. Biomed Res Int, 2018, 2018: 6389157.

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Chinese Journal of Reparative and Reconstructive Surgery

Standardized management of platelet derivatives for tissue regeneration research and applications

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