A phase IIa open-label dose-escalation pilot study using allogeneic human dermal fibroblasts for nasolabial folds.
OBJECTIVE
The correction of soft tissue contour defects and dermal atrophy is a growing area driven by medical and aesthetic need. Deterioration of the skin's appearance occurs as a result of age and trauma, such as surgery, infections, and acne. Typically, imperfections are treated with volume-correcting fillers. This study evaluated allogeneic human dermal fibroblasts (HDFs) for the treatment of nasolabial folds as an alternative strategy to improve the structure, texture, and quality of the skin.


METHODS
In this phase IIa study, a suspension of allogeneic HDF (2 × 10(6) cells/mL or 2 × 10(7) cells/mL) was injected intradermally along the nasolabial fold; line severity was assessed using a photographic scale.


RESULTS
Mean investigator satisfaction was 7.4 (range 4.7-9.5) at 12 weeks and 7.6 (range 4.4-9.8) at 24 weeks. Subject satisfaction scores were 7.0 (range 0.1-10.0) at 12 weeks and 7.8 (range 1.5-10.0) at 24 weeks. All patients experienced adverse events, the majority of which were deemed treatment related. Most were mild to moderate in severity and resolved completely.


CONCLUSIONS
This study demonstrated that allogeneic HDF can produce an improvement in aesthetic appearance with minimal adverse events and warrants further investigation and development. Intercytex provided financial support for this study. John Roberts is an employee of Intercytex.
Lowe
Nicholas J
NJ
Department of Dermatology, School of Medicine, University of California at Los Angeles, Los Angeles, California, USA. cranley@cranleyclinic.com
Lowe
Philippa L
PL
St Clair Roberts
John
J
D000328:Adult; D015331:Cohort Studies; D020405:Dermis / Q000637:transplantation*; D005260:Female; D005347:Fibroblasts / Q000637:transplantation*; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D010865:Pilot Projects; D015361:Rhytidoplasty / Q000379:methods*; D015595:Skin Aging; D014184:Transplantation, Homologous; D016896:Treatment Outcome