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Autologous cell therapy for aged human skin: A randomized, placebo-controlled, phase-I study
Grether-Beck, S. Marini, A. Jaenicke, T. Goessens-Rück, P. McElwee, Kevin J. Hoffman, R. Krutmann, J.
Grether-Beck, S.
Marini, A.
Jaenicke, T.
Goessens-Rück, P.
McElwee, Kevin J.
Hoffman, R.
Krutmann, J.
Publication Date
2020-01
End of Embargo
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Rights
© 2019 S. Karger AG, Basel. This is the peer-reviewed but unedited manuscript version of the following article: Grether-Beck S, Marini A, Jaenicke T et al (2020) Autologous cell therapy for aged human skin: A randomized, placebo-controlled, phase-I study. Skin Pharmacology and Physiology. 33(1): 9-16. The final, published version is available at http://www.karger.com/?doi=10.1159/000502240
Peer-Reviewed
Yes
Open Access status
openAccess
Accepted for publication
2019-07-19
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Abstract
Introduction: Skin ageing involves senescent fibroblast accumulation, disturbance in extracellular matrix (ECM) homeostasis, and decreased collagen synthesis. Objective: to assess a cell therapy product for aged skin (RCS-01; verum) consisting of ~25 × 106 cultured, autologous cells derived from anagen hair follicle non-bulbar dermal sheath (NBDS). Methods: For each subject in the verum group, 4 areas of buttock skin were injected intradermally 1 or 3 times at monthly intervals with RCS-01, cryomedium, or needle penetration without injection; in the placebo group RCS-01 was replaced by cryomedium. The primary endpoint was assessment of local adverse event profiles. As secondary endpoints, expression of genes related to ECM homeostasis was assessed in biopsies from randomly selected volunteers in the RCS-01 group taken 4 weeks after the last injection. Results: Injections were well tolerated with no severe adverse events reported 1 year after the first injection. When compared with placebo-treated skin, a single treatment with RCS-01 resulted in a significant upregulation of TGFβ1, CTGF, COL1A1, COL1A2, COL3A1, and lumican mRNA expression. Limitations: The cohort size was insufficient for dose ranging evaluation and subgroup analyses of efficacy. Conclusions: RCS-01 therapy is well tolerated and associated with a gene expression response consistent with an improvement of ECM homeostasis.
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Accepted manuscript
Citation
Grether-Beck S, Marini A, Jaenicke T et al (2020) Autologous cell therapy for aged human skin: A randomized, placebo-controlled, phase-I study. Skin Pharmacology and Physiology. 33(1): 9-16.
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Article