The First Live-Cell Based Product in The Iranian Drug List; ReColorCell®

Document Type : Commentary

Authors

Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran

Abstract

Vitiligo is an autoimmune skin disorder that can significantly affect the quality of life in patients. However, current
treatment strategies such as phototherapy, topical glucocorticosteroids, or systemic immunosuppressants can
be helpful in vitiligo management, and treatments for disease stability which is the main challenge in vitiligo
management. Novel therapeutic modalities have made promising advances in this regard. Molecular targeted
therapy to target Janus-activated kinase (JAK) such as Tofacitinib and Ruxolitinib in addition to the cell-based
treatments are innovative therapeutic options, which are recently used for vitiligo treatment. Transplantation of
non-cultured melanocytes-keratinocytes have been studied in Iran and phase one data published in 2010 on 10
patients that continued on 300 patients as phase three in 2018. Cell Tech Pharmed™ Co. registered and applied
this cell-based product, ReColorCell®, as a GMP certified by Iranian Food and Drug Administration (IR-FDA). On
11th December 2021, ReColorCell® officially registered as the first cell-based product in the Iranian drug list (IDL).
Currently, the post-market study of this product is ongoing.

Keywords


  1. Chen J, Li S, Li C. Mechanisms of melanocyte death in vitiligo. Med Res Rev. 2021; 41(2): 1138-1166.
  2. Spritz RA, Andersen GH. Genetics of vitiligo. Dermatol Clin. 2017; 35(2): 245-255.
  3. Bergqvist C, Ezzedine K. Vitiligo: a review. Dermatology. 2020; 236(6): 571-592.
  4. Hedayat K, Karbakhsh M, Ghiasi M, Goodarzi A, Fakour Y, Akbari Z, et al. Quality of life in patients with vitiligo: a cross-sectional study based on vitiligo quality of life index (VitiQoL). Health Qual Life Outcomes. 2016; 14: 86. 5. Kubelis-López DE, Zapata-Salazar NA, Said-Fernández SL, Sánchez-Domínguez CN, Salinas-Santander MA, Martínez-Rodríguez HG, et al. Updates and new medical treatments for vitiligo (Review). Exp Ther Med. 2021; 22(2): 797.
  5. Abdel-Malek ZA, Jordan C, Ho T, Upadhyay PR, Fleischer A, Hamzavi I. The enigma and challenges of vitiligo pathophysiology and treatment. Pigment Cell Melanoma Res. 2020; 33(6): 778-787.
  6. Narayan VS, Uitentuis SE, Luiten RM, Bekkenk MW, Wolkerstorfer A. Patients’ perspective on current treatments and demand for novel treatments in vitiligo. J Eur Acad Dermatol Venereol. 2021; 35(3): 744-748.
  7. Bishnoi A, Parsad D. Clinical and molecular aspects of vitiligo treatments. Int J Mol Sci. 2018; 19(5): 1509.
  8. Feng Y, Lu Y. Advances in vitiligo: update on therapeutic targets. Front Immunol. 2022; 13: 986918.
  9. Shahrbaf MA, Nouri M, Zarrabi M, Gramignoli R, Vosough M. Extraembryonic mesenchymal stromal/stem cells in liver diseases: a critical revision of promising advanced therapy medicinal products. Cells. 2022; 11(7): 1074.
  10. Howell MD, Kuo FI, Smith PA. Targeting the janus kinase family in autoimmune skin diseases. Front Immunol. 2019; 10: 2342.
  11. Zokaei S, Farhud DD, Keykhaei M, Zarif Yeganeh M, Rahimi H, Moravvej H. Cultured epidermal melanocyte transplantation in vitiligo: a review article. Iran J Public Health. 2019; 48(3): 388-399.
  12. Chang WL, Lee WR, Kuo YC, Huang YH. Vitiligo: an autoimmune skin disease and its immunomodulatory therapeutic intervention. Front Cell Dev Biol. 2021; 9: 797026.
  13. Zhu L, Lin X, Zhi L, Fang Y, Lin K, Li K, et al. Mesenchymal stem cells promote human melanocytes proliferation and resistance to apoptosis through PTEN pathway in vitiligo. Stem Cell Res Ther. 2020; 11(1): 26.
  14. Bassiouny D, Esmat S. Autologous non-cultured melanocyte-keratinocyte transplantation in the treatment of vitiligo: patient selection and perspectives. Clin Cosmet Investig Dermatol. 2018; 11: 521-540.
  15. Guerra L, Primavera G, Raskovic D, Pellegrini G, Golisano O, Bondanza S, et al. Erbium:YAG laser and cultured epidermis in the surgical therapy of stable vitiligo. Arch Dermatol. 2003; 139(10): 1303-1310.
  16. Khodadadi L, Shafieyan S, Sotoudeh M, Dizaj AV, Shahverdi A, Aghdami N, et al. Intraepidermal injection of dissociated epidermal cell suspension improves vitiligo. Arch Dermatol Res. 2010; 302(8): 593-599.
  17. Orouji Z, Bajouri A, Ghasemi M, Mohammadi P, Fallah N, Shahbazi A, et al. A single-arm open-label clinical trial of autologous epidermal cell transplantation for stable vitiligo: a 30-month follow-up. J Dermatol Sci. 2018; 89(1): 52-59.
  18. Saberi S, Karamzadeh R, Moghadam P, Kadivari M, Eghbal Behbahani B, Heydari Z, et al. Research performance in stem cell science and regenerative medicine in Iran: a national comprehensive observation. Arch Iran Med. 2019; 22(6): 318-327.
  19. Brhlikova P, Maigetter K, Murison J, Agaba AG, Tusiimire J, Pollock AM. Registration and local production of essential medicines in Uganda. J Pharm Policy Pract. 2020; 13: 31.