Human Autologous Cultured Fibroblast Cells (Azficel-t)

What it is and how it works

Azficel-T consists of the patient’s own dermal fibroblasts, harvested from a small skin biopsy (usually post-auricular) and expanded in culture. Injected intradermally, the fibroblasts are intended to produce collagen and extracellular matrix, improving dermal volume at the treated site.

Indications

Improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

Dosage and administration (summary)

Dosing is individualised by the treating specialist: the cultured cells are injected intradermally into the treated area in a series of sessions according to the manufacturer’s protocol.

Contraindications

Active skin infection at the injection site; known hypersensitivity to components used in manufacture (e.g. gentamicin, amphotericin B, bovine material).

Warnings and precautions

Bruising, erythema, swelling and pain at injection sites are common. As an autologous product it must be administered only to the patient from whom it was derived; chain-of-identity checks are essential. Caution in patients on anticoagulants or antiplatelet drugs and in those with a history of keloid formation.

Storage and supply

Shipped and stored at 2–8 °C; do not freeze; use within the shelf life stated by the manufacturer.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.