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.