TITLE:
Efficacy of Autologous Cultured Fibroblast Cells as a Treatment for Patients with Facial Contour Defects: A Clinical Replication Study
AUTHORS:
Edward Charles R. Lee, Kim Siea Lee, Jezamine Lim, Jason Yip, Cheng Zhang, Xu Zhang, Han Bin, To Lim
KEYWORDS:
Facial Contour Defect, Nasolabial Fold, Wrinkle, Autologous Cultured Fibroblast Cell, Autologous Cell Therapy
JOURNAL NAME:
Journal of Cosmetics, Dermatological Sciences and Applications,
Vol.7 No.4,
November
20,
2017
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 points 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.