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dc.contributor.authorGrether-Beck, S.
dc.contributor.authorMarini, A.
dc.contributor.authorJaenicke, T.
dc.contributor.authorGoessens-Rück, P.
dc.contributor.authorMcElwee, Kevin J.
dc.contributor.authorHoffman, R.
dc.contributor.authorKrutmann, J.
dc.date.accessioned2019-12-10T07:27:45Z
dc.date.accessioned2019-12-13T16:43:16Z
dc.date.available2019-12-10T07:27:45Z
dc.date.available2019-12-13T16:43:16Z
dc.date.issued2020-01
dc.identifier.citationGrether-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.en_US
dc.identifier.urihttp://hdl.handle.net/10454/17534
dc.descriptionYesen_US
dc.description.abstractIntroduction: 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.en_US
dc.description.sponsorshipReplicel Life Sciences Inc, Vancouver, Canada.en_US
dc.language.isoenen_US
dc.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=10.1159/000502240en_US
dc.subjectAutologous cell therapyen_US
dc.subjectAged human skinen_US
dc.subjectExtracellular matrixen_US
dc.subjectRandomized, double-blind, placebo-controlled, phase-I studyen_US
dc.titleAutologous cell therapy for aged human skin: A randomized, placebo-controlled, phase-I studyen_US
dc.status.refereedYesen_US
dc.date.Accepted2019-07-19
dc.date.application2019-09-11
dc.typeArticleen_US
dc.type.versionAccepted manuscripten_US
dc.identifier.doihttps://doi.org/10.1159/000502240
dc.date.updated2019-12-10T07:27:48Z
refterms.dateFOA2019-12-13T16:43:40Z


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