A paper entitled, "Autologous Cell
Therapy for Aged Human Skin: A Randomized, Placebo-Controlled,
Phase-I Study", has been published summarizing the data from
RepliCel's clinical trial of RCS-01
VANCOUVER, Sept. 24, 2019 /CNW/ - RepliCel Life Sciences
Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the
"Company"), a company developing next-generation technologies in
aesthetics and orthopedics, is pleased to announce the publication
of clinical data from its skin rejuvenation study (RCS-01) in an
article entitled, Autologous Cell Therapy for Aged Human Skin: A
Randomized, Placebo-Controlled, Phase-I Study, published
in the peer-reviewed journal Skin Pharmacology and
Physiology (Skin Pharmacol
Physiol http://dx.doi.org/10.1159/000502240).
The publication summarizes data from a clinical trial in which
it was shown that RepliCel's RCS-01 injections are well-tolerated
for up to one-year post-injection and therefore safe to use. The
study also demonstrated how the injections might reverse the
effects of aging skin. As summarized in the paper, the study
clearly established a biological link between RCS-01 injections and
changes in the expression of particular genes in the skin. These
changes in gene expression are expected to be indicative of the
potential for rejuvenation of the extra-cellular matrix (ECM) under
the dermis that is so important to vibrant, youthful
skin.
"We are very pleased that the esteemed, peer-reviewed journal,
Skin Pharmacology and Physiology saw the merit of RepliCel's
clinical work," stated RepliCel President & CEO, R. Lee
Buckler, "and the potential of our proprietary cell therapy,
RCS-01, for skin rejuvenation."
The publication presents data showing for the first time that
injections of NBDS-derived autologous cells into the human skin
dermis layer alters the transcriptional expression profile of
genes, which are involved in ECM homeostasis. Specifically, in
comparison to placebo treated skin areas, injection of NBDS-derived
fibroblasts promoted the expression of the genes TGFbeta1, CTGF,
COL1A1, COL1A2, COL3A1 and lumican. These genes encode for
proteins which are important for ECM homeostasis, thought to be of
pathogenetic relevance for skin aging. In aged skin, levels of type
1 and type 3 collagen precursors and crosslinks are reduced.
The observation that injection of NBDS-derived cells is
associated with an increased transcriptional expression of these
genes indicates the possibility that cell therapy treatment with
RCS-01 might ameliorate the clinical and aesthetic signs of skin
aging, such as wrinkles. This assumption is in line with
observations that increased expression of collagen type 1 and type
3 is a prerequisite for wrinkle reduction caused by retinol.
More about the senior authors
Professor Dr. med Jean Krutmann, the paper's senior author, is
Professor of Dermatology and Environmental Medicine and Director of
the IUF Leibniz Research Institute for Environmental Medicine at
the Heinrich-Heine-University Düsseldorf where the study was
conducted. He is a coordinator of the Leibniz Research Alliance
"Healthy Aging" (a strategic alliance of 23 Leibniz institutes).
His research is in the field of derma-toxicology and
immune-dermatology with special emphasis on environmentally-induced
skin diseases and skin aging. Prof. Krutmann is author or co-author
of more than 400 papers. He is the recipient of the International
Arnold-Rikli-Award, the Albert
Fleckenstein Award, the Paul Gerson
Unna Award, the Oscar Gans
Award, the C.E.R.I.E.S. Research Support Award, the Dermopharmacy
Innovation Award and the Xu Guang Qi Lecturer Award.
He is a visiting and adjunct professor at the Nagoya City University, Japan, Case Western
Reserve University, Cleveland,
Ohio, University of Alabama,
Birmingham, AL, USA, and Fudan University, Shanghai, China. He is a member of the
National Academy of Science of Germany. He is a clinical consultant to
RepliCel Life Sciences and is contributing to the RepliCel-YOFOTO
collaboration in China as it
relates to the clinical development and commercialization of
RepliCel's RCS-01 skin rejuvenation product.
About Aging and UV-damaged Skin Treatment
Markets
Ultra-violet (UV) light exposure from the sun is
responsible for up to 80% of visible facial skin aging. According
to statistics from the American Society for Plastic Surgeons,
$2.5 billion was spent on facial
aesthetics in 2013 and this is predicted to grow to over
$5.4 billion by 2020. Dermal filler
procedures are growing over 15% annually.
About the RCS-01 Study
The clinical trial was a
randomized, double-blind, placebo-controlled, single-centre, phase
I safety study of intradermal injections of RCS-01 in healthy
subjects. The primary endpoint was to assess the local safety
profile by recording and evaluating adverse events reported at the
treatment evaluation sites. Secondary safety measures related to
any reporting of systemic adverse events and assessment of
histopathological abnormalities of the treatment sites. Secondary
endpoints also included evaluating any changes in expression of
selected gene markers (using real-time, quantitative PCR) related
to intrinsic skin aging, skin wrinkling and solar degeneration of
skin. After trial inclusion, all participants provided a biopsy
from the scalp from which RCS-01 was prepared at a central GMP
manufacturing site. Study participants were randomized to either a
RCS-01 or placebo subgroup. Each participant had four treatment
evaluation sites identified on their buttocks, two on each side, to
allow for a within-subject comparison of single and triple
injections of RCS-01 with placebo respectively. Participants in the
RCS-01 Subgroup received injections of RCS-01 or placebo or a
'sham' injection (a needle penetration without injection of
liquid). Participants in the Placebo Subgroup received only
injections of placebo or sham injections to compare the systemic
safety profile to the RCS Subgroup. Baseline evaluations of
subjects' overall health and skin condition at treatment sites on
their buttocks were performed before receipt of injections at Day
0. In addition to injections delivered at Day 0, the pre-selected
treatment evaluation sites received intradermal injections of
RCS-01, or placebo, or a sham injection four and eight weeks after
Day 0 according to a randomization schedule, for a total of three
injections per treatment site. All participants returned to the
clinic at regular intervals to monitor safety. Assessment of the
local safety profile was performed by the investigator before each
injection visit, two to four days after injection, and up to 44
weeks after the last injection. The investigator assessed local
tolerance according to a comprehensive list of pre-specified
adverse events. Other study assessments included recording of vital
signs at each visit and routine laboratory assessments at regular
intervals. At the 12-week time point, nine randomly selected
participants provided biopsies from all injection sites for gene
expression analysis of skin markers related to aging. At Week-26
the remaining participants provided biopsies of all injection sites
for histopathological analysis. All reported pre-defined local
adverse events related to injection or sham were transient and
mainly mild in intensity only. No other related local or systemic
adverse events were reported. No clinically relevant abnormal
laboratory results or abnormal vital signs were reported.
Histopathological assessments of treatment evaluation site biopsies
were all judged to be normal by a blinded investigator.
About RepliCel Life Sciences
RepliCel is a
regenerative medicine company focused on developing cell therapies
for aesthetic and orthopedic conditions affecting what the Company
believes is approximately one in three people in industrialized
nations, including aging/sun-damaged skin, pattern baldness, and
chronic tendon degeneration. These conditions, often
associated with aging, are caused by a deficit of healthy cells
required for normal tissue healing and function. The Company's
product pipeline is comprised of RCT-01 for tendon repair, RCS-01
for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is
currently being co-developed with, and under exclusive license by,
Shiseido for certain Asian countries. All product candidates are
based on RepliCel's innovative technology, utilizing cell
populations isolated from a patient's healthy hair follicles.
RepliCel has also developed a proprietary injection device, RCI-02,
optimized for the administration of its products and licensable for
use with other dermatology applications.
Please visit http://www.replicel.com for additional
information.
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SOURCE RepliCel Life Sciences Inc.
