Autologous fibroblasts
Autologous fibroblasts
The FDA-licensed Azficel-T (laViv®) in 2011 as a biologic product for the correction of moderate to severe nasolabial folds. Preparation of the material requires isolation and culture of autologous fibroblasts from punch biopsies of posterior auricular skin. These specimens are sent to the manufacturer who grows the cells in vitro until there is 1.2 mL of suspension containing 18 million patient- specific fibroblasts in Dulbecco’s Modified Eagle’s Medium (DMEM). In the pivotal phase 3 trial, there was a statistically significant improvement in the appearance of nasolabial folds at 6 months versus placebo. Efficacy beyond that length of time is less well established.38
Drawbacks of Azficel-T compared to other fillers include requisite skin biopsies, producing secondary defects and scars; delay between time of specimen collection and fibroblast injection; unclear duration of correction; limited yield based on volume and quality of biopsy tissue sent; and high cost. Hence, several other products (i.e.,
Autologen®, Fibrel®, Isolagen®) derived from autologous fibroblasts are no longer sold in the United States.