A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles.

Background Changes associated with aging are partly due to loss of collagen and elastin. Treatment with autologous fibroblasts grown in culture (azficel-T) can help correct the appearance of aging by replacing lost dermal constituents. Objective To demonstrate the safety and effectiveness of autologous fibroblasts in the treatment of nasolabial fold (NLF) wrinkles. Methods and Materials Adults with moderate to very severe NLF wrinkles were randomized to receive three treatments with autologous fibroblasts or placebo at 5-week intervals. Blinded evaluators and subjects assessed efficacy using a validated wrinkle assessment scale. Results Three hundred seventy-two subjects were enrolled and underwent treatment. Seventy-eight percent of subjects treated with autologous fibroblast therapy and 48% of subjects treated with placebo achieved at least a 1-point improvement on the subject assessment at 6 months (p < 0.001), and 64% of subjects treated with autologous fibroblast therapy and 36% of those treated with placebo showed at least a 1–point improvement evaluator's assessment (p < 0.001). Adverse events were generally mild, and the treatment was well tolerated. Conclusion Autologous fibroblast therapy is safe and effective for the treatment of NLF wrinkles. The availability of autologous cell therapy marks the beginning of a new phase in aesthetic therapy.