Long-Term Follow-Up of Autologous Fibroblast Transplantation For Facial Contour Deformities, A Non-Randomized Phase Iia Clinical Trial

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).