Efficacy of Autologous Cultured Fibroblast Cells as a Treatment for Patients with Facial Contour Defects: A Clinical Replication Study

Abstract

Background: The US FDA has recently approved autologous cultured fibroblast cells (ACF) as treatment for cutaneous contour defects. ACF provides an alternative to synthetic fillers or fat grafting with the significant advantage of producing longer lasting effect. Methods: This was a prospective open label single group clinical study to demonstrate the clinical efficacy of ACF that we have replicated in our lab. The study enrolled 18 patients with nasolabial folds from 2 centres in Malaysia in 2011-2012. ACF at dose of 23 or 92 million cells were injected on 3 occasions at 4 weeks interval. Efficacy at 6- and 12-month post treatment was assessed using a standardized 7-point scale which was performed by the 2 investigators as well as a panel of 7 independent evaluators. Results: We obtained a successful outcome (primary endpoint), defined as improvement in the appearance of the nasolabial fold of at least 2 point s on the 7-point scale, in 33% of patients as assessed by investigators at 12-month follow-up and in 22% of patients assessed by independent evaluators. Investigators also found 78% of patients having had a 1-point improvement from baseline while independent evaluators found 83% of patients having improved by as much. Patients were uniformly (100%) satisfied with the improvement in their appearance. No treatment - related adverse event was reported. Baseline score and follow - up duration had significant effect on treatment response. The greater the baseline severity and the longer the post-treatment follow-up, the better the response to ACF. Larger dose of cells (92 million cells) has little additional effect suggesting that the 1 mL dose (23 million cells) is near optimal. Older patients showed a trend towards poorer response but this was not statistically significant. Conclusions: We have successfully replicated the laboratory method and clinical procedure to perform ACF treatment which was effective in improving the appearance of nasolabial folds in some patients.