Long-Term Follow-up of Autologous Fibroblast Transplantation for Facial Contour Deformities, A Non-Randomized Phase IIa Clinical Trial

Abstract

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).

Keywords: Cell Therapy; Skin Rejuvenation; Wrinkle.

Fig.1

Study design and timeline. A. Study design for wrinkle participants, B. Study design for acne scar participants, and C. Study events and timeline. Eligible participants underwent three autologous cultured fibroblast injections. Efficacy data are based on comparisons of the baseline and follow-up evaluator and patient’s assessment scores.

Fig.2

Efficacy outcomes. A. Evaluator’s assessment score of the total sites in participants with wrinkles. Numbers are median, B. Evaluator’s assessment score of the total sites in participants with acne scars. Numbers are median, C. The percentages of participants with wrinkles with a 2-point improvement based on the evaluator assessment, D. The percentages of participants with acne scars with a 2-point improvement based on the evaluator assessment, E. Participants’ self-assessment scores of the total sites in participants with wrinkles, and F. Participants’ self-assessment scores of the total sites in participants with acne scars. *; P<0.05. 0; Nodifference, 1; Better or good, and 2; Much better or excellent.

Fig.3

Participants underwent autologous cultured fibroblast transplanta- tion before and after treatment.

Fig.4

Characteristics of cultured fibroblasts. A. Phase-contrast microscopy of fibroblasts shows spindle and elongated cells after cultivation (scale bar: 50 µm). Representative fluorescent staining shows: B. Vimentin (scale bar: 100 µm), C. Collagen type I expression in cultured fibroblast cells (scale bar: 100 µm). Nuclear stained by DAPI (blue), and D. Karyogram of cultured fibroblasts indicates no abnormality in third passage.