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A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles.Dermatol Surg. 2012 Jul; 38(7 Pt 2):1234-43.DS
Abstract
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.
Links
MeSH
Pub Type(s)
Journal Article
Multicenter Study
Randomized Controlled Trial
Language
eng
PubMed ID
22409385
Citation
Smith, Stacy R., et al. "A Multicenter, Double-blind, Placebo-controlled Trial of Autologous Fibroblast Therapy for the Treatment of Nasolabial Fold Wrinkles." Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [et Al.], vol. 38, no. 7 Pt 2, 2012, pp. 1234-43.
Smith SR, Munavalli G, Weiss R, et al. A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles. Dermatol Surg. 2012;38(7 Pt 2):1234-43.
Smith, S. R., Munavalli, G., Weiss, R., Maslowski, J. M., Hennegan, K. P., & Novak, J. M. (2012). A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles. Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [et Al.], 38(7 Pt 2), 1234-43. https://doi.org/10.1111/j.1524-4725.2012.02349.x
Smith SR, et al. A Multicenter, Double-blind, Placebo-controlled Trial of Autologous Fibroblast Therapy for the Treatment of Nasolabial Fold Wrinkles. Dermatol Surg. 2012;38(7 Pt 2):1234-43. PubMed PMID: 22409385.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR
T1 - A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles.
AU - Smith,Stacy R,
AU - Munavalli,Girish,
AU - Weiss,Robert,
AU - Maslowski,John M,
AU - Hennegan,Kevin P,
AU - Novak,Jeanne M,
Y1 - 2012/03/12/
PY - 2012/3/14/entrez
PY - 2012/3/14/pubmed
PY - 2012/10/2/medline
SP - 1234
EP - 43
JF - Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
JO - Dermatol Surg
VL - 38
IS - 7 Pt 2
N2 - 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.
SN - 1524-4725
UR - https://www.unboundmedicine.com/medline/citation/22409385/A_multicenter
L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=1076-0512&date=2012&volume=38&issue=7 Pt 2&spage=1234
DB - PRIME
DP - Unbound Medicine
ER -
