Finished product reference
Human Autologous Skin Melanocyte & Keratinocyte Cells
Injection, Suspension · Intraepidermal · 4 mL
- List code
- 53045
- Pharmacologic class
- Autologous cellular product (epidermal cell suspension)
What it is and how it works
A suspension of the patient’s own melanocytes and keratinocytes is prepared from a thin split-thickness skin graft taken from a pigmented donor site. Applied to dermabraded depigmented skin, the transplanted melanocytes repopulate the area and restore pigmentation.
Indications
Repigmentation of stable, treatment-resistant vitiligo (segmental or non-segmental) and other stable leucodermas; also used as an adjunct in epidermal wound and burn repair.
Dosage and administration (summary)
Dosing is individualised by the specialist: the cell suspension is applied to the prepared recipient area in a single procedure, with the donor-to-recipient area ratio set according to protocol.
Contraindications
Unstable or actively spreading vitiligo; tendency to keloid or hypertrophic scarring; active infection at donor or recipient site.
Warnings and precautions
Disease stability (typically no new lesions for at least 12 months) should be confirmed before treatment. Possible adverse effects include donor-site scarring, infection, uneven or incomplete repigmentation and Koebner phenomenon. The product must be used only in the patient from whom it was derived.
Storage and supply
Prepared immediately before use and applied fresh in the same procedure.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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