Volume 31, Issue 11 (February 2021)
Studies in Medical Sciences 2021, 31(11): 847-862 |
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Golchin A, Mohammadpour S, Kangari P, Roshangar L, Ai J. OVERVIEW OF BIOLOGIC PRODUCTS WITH MARKETING AUTHORIZATION APPROVAL FOR CLINICAL APPLICATION. Studies in Medical Sciences 2021; 31 (11) :847-862
URL: http://umj.umsu.ac.ir/article-1-5032-en.html
URL: http://umj.umsu.ac.ir/article-1-5032-en.html
Assistant Professor of applied cell sciences, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran (Corresponding author) , agolchin.vet10@yahoo.com
Abstract: (3402 Views)
Background & Aims: Among the different fields of modern medical sciences, regenerative medicine has attracted the attention of many researchers and physicians. The development of this branch of medicine has increased hopes for the treatment of incurable diseases. As a new idea in regenerative medicine in interaction with tissue engineering and genetics, cell therapy has been able to snatch the lead in modern medical sciences and confirm the clinical use of several cell-based pharmaceutical products. Cell therapy aims to transplant healthy human cells to replace or repair damaged cells for therapeutic purposes. Hence, this study aims to introduce and review approved cell-based drugs that are currently used in therapy.
Materials & Methods: This study is a non-systematic review in which all biological products with therapeutic approval worldwide were extracted and reported from relevant organizations' sites.
Articles were also searched manually and electronically in PubMed, Scopus, and Science Direct databases.
Results: Since cell therapy products are related to products based on gene therapy and tissue engineering, all biological products with clinical use approval were collected and introduced from different countries. In total, the United States with 16 products, South Korea with 14 products, and the European Union with 8 products had the highest number of cell therapy products, respectively.
Conclusion: Due to the novelty of this branch of medicine and the entry of cell therapy-based products into the consumer market, a rising trend in production and attention to the future of reconstructive medicine and cell therapy is predictable.
Materials & Methods: This study is a non-systematic review in which all biological products with therapeutic approval worldwide were extracted and reported from relevant organizations' sites.
Articles were also searched manually and electronically in PubMed, Scopus, and Science Direct databases.
Results: Since cell therapy products are related to products based on gene therapy and tissue engineering, all biological products with clinical use approval were collected and introduced from different countries. In total, the United States with 16 products, South Korea with 14 products, and the European Union with 8 products had the highest number of cell therapy products, respectively.
Conclusion: Due to the novelty of this branch of medicine and the entry of cell therapy-based products into the consumer market, a rising trend in production and attention to the future of reconstructive medicine and cell therapy is predictable.
Type of Study: Review article |
Subject:
بیوشیمی
References
1. Quinley ED. Quality and Regulatory Issues in Cellular Therapy. In: Shaz BH, Hillyer CD, editor. Elsevier; 2013.. p. 577-84. [DOI:10.1016/B978-0-12-397164-7.00087-2]
2. Shi PA. Chapter 57 - Patient Blood Management. In: Transfusion Medicine and Hemostasis. 2013. p. 373-81. [DOI:10.1016/B978-0-12-397164-7.00057-4]
3. Golchin A, Farahany TZ, Khojasteh A, Soleimanifar F, Ardeshirylajimi A. The Clinical Trials of Mesenchymal Stem Cell Therapy in Skin Diseases: An Update and Concise Review. Curr Stem Cell Res Ther 2018 ;14(1):22-33. [DOI:10.2174/1574888X13666180913123424] [PMID]
4. Golchin A, Rekabgardan M, Taheri RA, Nourani MR. Promotion of Cell-Based Therapy: Special Focus on the Cooperation of Mesenchymal Stem Cell Therapy and Gene Therapy for Clinical Trial Studies. In: Turksen K, editor. Advances in experimental medicine and biology [Internet]. Springer, New York, NY; 2018.p. 103-18. Available from: http://link.springer.com/10.1007/5584_2018_256 [DOI:10.1007/5584_2018_256] [PMID]
5. Golchin A, Chatziparasidou A, Ranjbarvan P, Niknam Z, Ardeshirylajimi A. Embryonic Stem Cells in Clinical Trials: Current Overview of Developments and Challenges. In: Advances in Experimental Medicine and Biology [Internet]. Springer, New York, NY; 2020 [cited 2020 Nov 19]. p. 1-19. Available from: http://link.springer.com/10.1007/5584_2020_592 [DOI:10.1007/5584_2020_592] [PMID]
6. Gallo S, Sangiolo D, Carnevale Schianca F, Aglietta M, Montemurro F. Treating breast cancer with cell-based approaches: an overview. Expert Opin Biol Ther2017;17(10):1255-64. Available from: http://www.ncbi.nlm.nih.gov/pubmed/28728493 [DOI:10.1080/14712598.2017.1356816] [PMID]
7. Singh HM, Ungerechts G, Tsimberidou AM. Gene and cell therapy for pancreatic cancer. Expert Opin Biol Ther 2015;15(4):505-16. [DOI:10.1517/14712598.2015.1001734] [PMID]
8. Rivière I, Sadelain M. Chimeric Antigen Receptors: A Cell and Gene Therapy Perspective. Mol Ther. 2017;25(5):1117-24. [DOI:10.1016/j.ymthe.2017.03.034] [PMID] [PMCID]
9. Golchin A, Niknejad H. Cell Therapy Using Embryonic Stem Cell Source in Clinical Trial Studies: Advantages and Limitations. J Maz Univ Med Sci 2017 ;27(148):161-75. [Google Scholar]
10. Chen C-H, Sereti K-I, Wu BM, Ardehali R. Translational aspects of cardiac cell therapy. J Cell Mol Med 2015;19(8):1757-72. [DOI:10.1111/jcmm.12632] [PMID] [PMCID]
11. Salehi-Nik N, Rezai Rad M, Kheiri L, Nazeman P, Nadjmi N, Khojasteh A. Buccal Fat Pad as a Potential Source of Stem Cells for Bone Regeneration: A Literature Review. Stem Cells Int 2017 ;2017:1-13. [DOI:10.1155/2017/8354640] [PMID] [PMCID]
12. Budd E, Waddell S, de Andrés MC, Oreffo ROC. The Potential of microRNAs for Stem Cell-based Therapy for Degenerative Skeletal Diseases. Curr Mol Biol Reports 2017;3(4):263-75. [DOI:10.1007/s40610-017-0076-4] [PMID] [PMCID]
13. Chal J, Pourquié O. Making muscle: skeletal myogenesis in vivo and in vitro. Development 2017;144(12):2104-22. A [DOI:10.1242/dev.151035] [PMID]
14. Golchin A, Seyedjafari E, Ardeshirylajimi A. Mesenchymal Stem Cell Therapy for COVID-19: Present or Future. Stem Cell Rev Rep 2020 : 1-7.. [DOI:10.1007/s12015-020-09973-w] [PMID] [PMCID]
15. Golchin A. Cell-Based Therapy for Severe COVID-19 Patients: Clinical Trials and Cost-Utility. Stem Cell Rev Rep2020 :1-7. [DOI:10.1007/s12015-020-10046-1] [PMID] [PMCID]
16. Cuende N, Rasko JEJ, Koh MBC, Dominici M, IKONOMOU L. Cell, tissue and gene products with marketing authorization in 2018 worldwide. Cytotherapy 2018;20(11):1401-13. [DOI:10.1016/j.jcyt.2018.09.010] [PMID]
17. Research C for BE and. Cellular & Gene Therapy Products. 2018 [cited 2018 May 6]; Available from: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/default.htm [Google Scholar]
18. Stockwell S. Oncology times. Lippincott Williams & Wilkins; 2016. p. 12. [URL]
19. Research C for BE and. Approved Products - CLEVECORD (HPC Cord Blood). 2016 [cited 2018 May 7];20(38):12. Available from: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm518869.htm [DOI:10.1097/01.COT.0000505534.78469.5e]
20. Allison M. Hemacord approval may foreshadow regulatory creep for HSC therapies. Nat Biotechnol 2012;30(4):304. [DOI:10.1038/nbt0412-304] [PMID]
21. Schmidt C. FDA approves first cell therapy for wrinkle-free visage. Nat Biotechnol 2011;29(8):674-5. [DOI:10.1038/nbt0811-674] [PMID]
22. McArdle A, Senarath-Yapa K, Walmsley GG, Hu M, Atashroo DA, Tevlin R, et al. The role of stem cells in aesthetic surgery: fact or fiction? Plast Reconstr Surg 2014;134(2):193-200. [DOI:10.1097/PRS.0000000000000404] [PMID] [PMCID]
23. Gobbi A, Kon E, Berruto M, Francisco R, Filardo G, Marcacci M. Patellofemoral Full-Thickness Chondral Defects Treated with Hyalograft-C. Am J Sports Med 2006;34(11):1763-73. [DOI:10.1177/0363546506288853] [PMID]
24. Dunkin BS, Lattermann C. New and Emerging Techniques in Cartilage Repair: MACI. Oper Tech Sports Med. 2013;21(2):100-7. [DOI:10.1053/j.otsm.2013.03.003] [PMID] [PMCID]
25. Ochs BG, Müller-Horvat C, Albrecht D, Schewe B, Weise K, Aicher WK, et al. Remodeling of Articular Cartilage and Subchondral Bone After Bone Grafting and Matrix-Associated Autologous Chondrocyte Implantation for Osteochondritis Dissecans of the Knee. Am J Sports Med 2011;39(4):764-73. [DOI:10.1177/0363546510388896] [PMID]
26. Dekker TJ, Erickson B, Adams SB, Gross CE. Topical Review: MACI as an Emerging Technology for the Treatment of Talar Osteochondral Lesions. Foot Ankle Int 2017;38(9):1045-8. [DOI:10.1177/1071100717711482] [PMID]
27. Schmidt C. Gintuit cell therapy approval signals shift at US regulator. Nat Biotechnol 2012;30(6):479. [DOI:10.1038/nbt0612-479] [PMID]
28. Golchin A, Farahany TZTZ. Biological Products: Cellular Therapy and FDA Approved Products. Stem Cell Rev Reports 2019;15(2):1-10. [DOI:10.1007/s12015-018-9866-1] [PMID]
29. Zheng P-P, Kros JM, Li J. Approved CAR T cell therapies: ice bucket challenges on glaring safety risks and long-term impacts. Drug Discov Today 2018;23(6):1175-82. [DOI:10.1016/j.drudis.2018.02.012] [PMID]
30. Liu Y, Chen X, Han W, Zhang Y. Tisagenlecleucel, an approved anti-CD19 chimeric antigen receptor T-cell therapy for the treatment of leukemia. Drugs of Today 2017;53(11):597. [DOI:10.1358/dot.2017.53.11.2725754] [PMID]
31. Tisagenlecleucel (Kymriah) for ALL. Med Lett Drugs Ther 2017;59(1532):177-8. [PMID]
32. Shaberman B. A Retinal Research Nonprofit Paves the Way for Commercializing Gene Therapies. Hum Gene Ther 2017;28(12):1118-21. [DOI:10.1089/hum.2017.29058.bsh] [PMID] [PMCID]
33. Voretigene Neparvovec-rzyl (Luxturna) for Inherited Retinal Dystrophy. Med Lett Drugs Ther 2018 ;60(1543):53-5. [PMID]
34. Golchin A, Shams F, Kangari P, Azari A, Hosseinzadeh S. Regenerative Medicine: Injectable Cell-Based Therapeutics and Approved Products. Adv Exp Med Biol [Google Scholar]
35. Adv Exp Med Biol 2020;1237:75-95.
36. Research C for BE and. Approved Products - ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo). [cited 2018 May 10]; Available from: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm606681.htm [URL]
37. Siegal DM, Curnutte JT, Connolly SJ, Lu G, Conley PB, Wiens BL, et al. Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity. N Engl J Med 2015;373(25):2413-24. [DOI:10.1056/NEJMoa1510991] [PMID]
38. Biologicals: finished product | European Medicines Agency [Internet]. [cited 2020 Dec 10]. Available from: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/biologicals/biologicals-finished-product [URL]
39. Approved Cellular and Gene Therapy Products | FDA [Internet]. [cited 2020 Dec 10]. Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products [URL]
40. Best Treatment for Avascular Necrosis (AVN) [Internet]. [cited 2020 Dec 11]. Available from: https://www.regrow.in/ossgrow-for-avn [URL]
41. Products | JCR Pharmaceuticals Co., Ltd. [Internet]. [cited 2020 Dec 11]. Available from: https://www.jcrpharm.co.jp/en/site/en/biopharmaceutical/product_tem.html [URL]
42. Igarashi T, Kaneko T, Yoshizawa S, Takada K, Matsu-ura Y, Ikegami H, et al. Autologous chondrocyte implantation with a Reveille cartilage processor for articular cartilage injury: a case report. J Surg Case Reports 2020;2020(4):1-7. [DOI:10.1093/jscr/rjaa074] [PMID] [PMCID]
43. Prochymal - First Stem Cell Drug Approved [Internet]. 2020 [cited 2020 Dec 11]. Available from: https://www.medicalnewstoday.com/articles/245704#1 [URL]
44. Medsafe Home Page [Internet]. [cited 2020 Dec 11]. Available from: https://www.medsafe.govt.nz/ [URL]
45. Cuende N, Rasko JEJ, Koh MBC, Dominici M, Ikonomou L. Cell, tissue and gene products with marketing authorization in 2018 worldwide. Cytotherapy 2018;20(11):1401-13. [DOI:10.1016/j.jcyt.2018.09.010] [PMID]
46. Corestem. First licensed stem cell therapy for ALS [Internet]. 2019. Available from: https://assets.zapnito.com/users/171693/documents/49888/1fa5a859-fbdc-4673-b44c-af6340216877.pdf [URL]
47. Manufactures|Bio&Cosmetics|Our Works|Minisry of Food and Drug Safety [Internet]. [cited 2020 Dec 11]. Available from: https://www.mfds.go.kr/eng/brd/m_30/view.do?seq=71337 [URL]
48. Manufactures|Bio&Cosmetics|Our Works|Minisry of Food and Drug Safety [Internet]. [cited 2020 Dec 11]. Available from: https://www.mfds.go.kr/eng/brd/m_30/view.do?seq=70957 [URL]
49. Manufactures|Bio&Cosmetics|Our Works|Minisry of Food and Drug Safety [Internet]. [cited 2020 Dec 11]. Available from: https://www.mfds.go.kr/eng/brd/m_30/view.do?seq=71390 [URL]
50. Manufactures|Bio&Cosmetics|Our Works|Minisry of Food and Drug Safety [Internet]. [cited 2020 Dec 11]. Available from: https://www.mfds.go.kr/eng/brd/m_30/view.do?seq=70954 [URL]
51. Yoon JS, Song BG, Lee JH, Lee HY, Kim SW, Chang Y, et al. Adjuvant cytokine-induced killer cell immunotherapy for hepatocellular carcinoma: A propensity score-matched analysis of real-world data. BMC Cancer 2019;19(1):523. [DOI:10.1186/s12885-019-5740-z] [PMID] [PMCID]
52. Yim H, Yang HT, Cho YS, Seo CH, Lee BC, Ko JH, et al. Clinical study of cultured epithelial autografts in liquid suspension in severe burn patients. Burns 2011 37(6):1067-71. [DOI:10.1016/j.burns.2011.03.018] [PMID]
53. Golchin A, Hosseinzadeh S, Ardeshirylajimi A. The exosomes released from different cell types and their effects in wound healing. J Cell Biochem 2018;119(7):5043-52. [DOI:10.1002/jcb.26706] [PMID]
54. Rezaie J, Rahbarghazi R, Pezeshki M, Mazhar M, Yekani F, Khaksar M, et al. Cardioprotective role of extracellular vesicles: A highlight on exosome beneficial effects in cardiovascular diseases. J Cell Physiol 2019;234(12):21732-45. 54. [DOI:10.1002/jcp.28894] [PMID]
55. Golchin A, Shams F, Karami F. Advancing mesenchymal stem cell therapy with CRISPR/Cas9 for clinical trial studies. Adv Exp Med Biol 2020;1247:89-100. [DOI:10.1007/5584_2019_459] [PMID]
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