A phase IIa open-label dose-escalation pilot study using allogeneic human dermal fibroblasts for nasolabial folds.

摘要: BACKGROUND AND OBJECTIVE The correction of soft tissue contour defects and dermal atrophy is a growing area driven by medical aesthetic need. Deterioration the skin's appearance occurs as result age trauma, such surgery, infections, acne. Typically, imperfections are treated with volume-correcting fillers. This study evaluated allogeneic human fibroblasts (HDFs) for treatment nasolabial folds an alternative strategy to improve structure, texture, quality skin. METHODS MATERIALS In this phase IIa study, suspension HDF (2 × 106 cells/mL or 2 107 cells/mL) was injected intradermally along fold; line severity assessed using photographic scale. RESULTS Mean investigator satisfaction 7.4 (range 4.7–9.5) at 12 weeks 7.6 4.4–9.8) 24 weeks. Subject scores were 7.0 0.1–10.0) 7.8 1.5–10.0) All patients experienced adverse events, majority which deemed related. Most mild moderate in resolved completely. CONCLUSION demonstrated that can produce improvement minimal events warrants further investigation development. Intercytex provided financial support study. John Roberts employee Intercytex.