Document Detail


A phase IIa open-label dose-escalation pilot study using allogeneic human dermal fibroblasts for nasolabial folds.
MedLine Citation:
PMID:  20722660     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND AND 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 AND MATERIALS: 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.
CONCLUSION: 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.
Authors:
Nicholas J Lowe; Philippa L Lowe; John St Clair Roberts
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article     Date:  2010-08-16
Journal Detail:
Title:  Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]     Volume:  36     ISSN:  1524-4725     ISO Abbreviation:  Dermatol Surg     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-29     Completed Date:  2010-12-15     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9504371     Medline TA:  Dermatol Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1578-85     Citation Subset:  IM    
Copyright Information:
© 2010 by the American Society for Dermatologic Surgery, Inc.
Affiliation:
Department of Dermatology, School of Medicine, University of California at Los Angeles, Los Angeles, California, USA. cranley@cranleyclinic.com
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MeSH Terms
Descriptor/Qualifier:
Adult
Cohort Studies
Dermis / transplantation*
Female
Fibroblasts / transplantation*
Humans
Male
Patient Satisfaction
Pilot Projects
Rhytidoplasty / methods*
Skin Aging*
Transplantation, Homologous
Treatment Outcome

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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