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

Document Type : Commentary


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


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.


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