The First Live-Cell Based Product in The Iranian Drug List; ReColorCell®.
Mohammad Amin ShahrbafLeila Ataei FashtamiAbdolhossein ShahverdiPublished in: Cell journal (2023)
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.
Keyphrases
- end stage renal disease
- chronic kidney disease
- ejection fraction
- newly diagnosed
- cell therapy
- single cell
- randomized controlled trial
- multiple sclerosis
- peritoneal dialysis
- patient reported outcomes
- stem cells
- pseudomonas aeruginosa
- bone marrow
- adverse drug
- tyrosine kinase
- cystic fibrosis
- mesenchymal stem cells
- patient reported
- single molecule