Autologous fibroblast therapy for facial rejuvenation: A randomized open-label controlled study.

BACKGROUND: The aging process of the face is characterized by dermal thinning, loss of elasticity, and wrinkle formation. Injection of autologous micrografts containing fibroblasts (Am-FBs) has emerged as a promising regenerative technique.
OBJECTIVES: This trial aims to assess the efficacy and safety of Am-FBs for facial rejuvenation.
METHODS: A randomized, open-label, controlled study was conducted. Forty patients presenting with mild to moderate dermal thinning, reduced elasticity, and wrinkles were divided into two groups: a study group (SG; n = 20) that received Am-FBs treatment and a control group (CG; n = 20) treated with a hyaluronic acid (HA)-based skin booster. Both groups received treatment at baseline (T0), at one month (T1), and at three months (T2). Clinical outcomes were evaluated at T1, T2, T3 (6 months), and T4 (12 months) through patient and physician evaluations, the Wrinkle Severity Rating Scale (WSRS), and objective skin elasticity metrics. In vitro evaluation of the Am-FBs and immunophenotypic characterization of the nucleated cell population contained in the Am-FBs suspension was performed.
RESULTS: At T4, the SG showed significantly greater improvements in wrinkle depth, skin elasticity, and WSRS score than the CG (p < 0.01). The physician's evaluation showed scores ranging from 9 to 4 (p = 0.049), whereas patient self-assessments ranged from 9 to 5 (p = 0.039). Patient satisfaction was higher in the SG. The in vitro analysis documented 2.780.750 nucleated cells/ml in Am-FBs with a viability of 89.61% and immunophenotype: CD34%0.2, CD45%0.2, CD44%98.7, CD200%80.0, Cytokeratin 15%99.4.
CONCLUSIONS: Am-FBs significantly improve signs of facial aging and present a safe option for skin rejuvenation.