Objective: Recently, the promising potential of fibroblast transplantation has become a novel modality for skin
rejuvenation. We investigated the long-term safety and efficacy of autologous fibroblast transplantation for participants
with mild to severe facial contour deformities.
Materials and Methods: In this open-label, single-arm phase IIa clinical trial, a total of 57 participants with wrinkles
(n=37, 132 treatment sites) or acne scars (n=20, 36 treatment sites) who had an evaluator’s assessment score of
at least 2 out 7 (based on a standard photo-guide scoring) received 3 injections of autologous cultured fibroblasts
administered at 4-6 week intervals. Efficacy evaluations were performed at 2, 6, 12, and 24 months after the final
injection based on evaluator and patient’s assessment scores.
Results: Our study showed a mean improvement of 2 scores in the wrinkle and acne scar treatment sites. At sixth
months after transplantation, 90.1% of the wrinkle sites and 86.1% of the acne scar sites showed at least a one grade
improvement on evaluator assessments. We also observed at least a 2-grade improvement in 56.1% of the wrinkle
sites and 63.9% of the acne scar sites. A total of 70.5% of wrinkle sites and 72.2% of acne scar sites were scored as
good or excellent on patient assessments. The efficacy outcomes remained stable up to 24-month. We did not observe
any serious adverse events during the study.
Conclusion: These results have shown that autologous fibroblast transplantation could be a promising remodeling
modality with long-term corrective ability and minimal adverse events (Registration Number: NCT01115634)