Hair Restoration

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Clinical Trial Results Of Growth Factor Microneedling
Hair Regrowth Treatment
COPYRIGHT 2018 CELLESE REGENERATIVE THERAPEUTICS
Cellese conducted a clinical trial of its 3-part combinatorial hair regrowth system, with each component
exploiting cellular signaling pathways not addressed by other products. The results of the trial proved the
efficacy of the proprietary system for stimulating hair regrowth.
A 12-week clinical study was conducted at Newport Aesthetics Research in Newport Beach, California from August 2017 to August 2018.
A total of 28 subjects were enrolled for an entire 12-week period. Volunteers received six microneedling sessions of the scalp, each
session two weeks apart, using specially formulated bio-signals. Subjects also received two take-home topical products specifically
formulated for hair regrowth. The products were to be used on their scalp in an alternating fashion with an at-home dermal stamp of
needle size 0.2mm twice a week.
Of those who completed the initial 12-week trial, twelve individuals decided to continue for an additional 12-week period for a total of 24
weeks.
For the initial 12-week trial period, 23 of 28 subjects (85%) self-reported a reduction in rate of hair loss or no hair loss during the course of
the 12-week study. Furthermore, 14 of 28 subjects (50%) reported visible new hair growth and 26 of 28 patients (93%) reported either
less hair loss or new hair growth. The investigator reported that 18 of 28 patients in the study had a moderately increased or greatly
increased amount of visible hair in balding areas during that same time frame.
For the 12 that participated in the full 24-week trial, 9 of 11 subjects (82%) self-reported a reduction in rate of hair loss or no hair loss.
Also, 7 of 12 subjects (58%) reported visible new hair growth, and 11 of 12 patients (92%) reported either less hair loss or new hair
growth. The investigator reported that 9 of 12 patients in the study (75%) had moderately increased or greatly increased amount of
visible hair in balding areas.
Abstract:
©2018 Cellese®. All rights reserved • Irvine, CA 92614 • 1 (877) 350-6350 • www.AnteAGE.com
Two primary efficacy parameters were assessed: Patient
assessment of hair growth at 12 and 24 weeks, and investigator
assessment of hair growth at 12 and 24 weeks. Subjects who
completed all 12 weeks or all 24 weeks of the trial were considered
in the respective evaluations. Five subjects dropped out during the
twelve-week study and their results are not included in the
summaries.
Results Summary:
The results confirmed earlier findings of a substantial reduction in
hair loss and/or halting hair loss altogether, and a significant
increase in new hair growth and/or less hair loss.
Patient subjective evaluation of hair growth at week 12 was a
primary efficacy variable with 85% reporting a reduction in rate of
hair loss or no hair loss during the course of the study. 50% reported
visible new hair growth, and 93% of patients reported either less
hair loss or new hair growth.
Investigator evaluation of hair growth at week 12 was a primary
efficacy variable with 64% of patients showing a +2 to +3 response
on a 7-point visual analogue scale, meaning a moderately increased
or greatly increased amount of visible hair in balding areas.
Patient subjective evaluation of hair growth at week 24 was a
primary efficacy variable with 82% reporting a reduction in rate of
hair loss or no hair loss during the course of the study. 58% reported
visible new hair growth, and 92% of patients reported either less
hair loss or new hair growth.
Investigator evaluation of hair growth at week 24 was a primary
efficacy variable, with 75% of patients showing a +2 to +3 response
on a 7-point visual analogue scale, meaning moderately increased
or greatly increased amount of visible hair in balding areas.
Efficacy assessment: 12-week study
Efficacy assessment: 24-week study
Wnt-Conditioned Media
The wnt//β-catenin signaling pathway enables activated cell surface
receptors to influence gene transcription at the nuclear level; they are
universally required for cell proliferation, differentiation and migration.
Hence, they are integral to hair follicle development and growth.
Prolonged ectopic Wnt-mediated β-catenin activation causes
regenerating anagen hair follicles to grow larger in size with
dramatically enhanced proliferation within the matrix, dermal papilla
and hair shaft. Wnt proteins are lipid-modified, constraining them to
act as short-range cellular signals only.
Stem cells fuel tissue development, renewal and regener-ation,
activities controlled by the local microenvironment, or “niche.” The
locality of Wnt controls how stem cells differ-entiate, indeed enabling
the self-organization of patterned tissues. The signaling pathway is an
ancient evolutionary program dating from when Wnt signals arose in
the simplest multicellular organism. Hair follicle genesis, function and
phase transitioning is impossible without Wnt signaling. We
manipulate human bone marrow mesenchymal stem cell cultures,
employing proprietary specialized techniques, enable harvesting of
conditioned media with a “wnt emphasis.”
Cucurbitacin B
Another regulator of gene expression that controls cellular processes
including growth and cycle progression is PAK1, a serine/threonine
kinase that regulates both physiologic and disease processes. PAK1
blockers, such as cucurbitacin B, have been shown to be
anti-oncogenic, anti-melanogenic and anti-alopecia i.e. promoting hair
growth. Among the many known herbal PAK1-inhibitors, cucurbitacin
B from bitter melon is the most potent in its ability to promote the
growth of hair cells.
Adenosine
Hair follicles produce hair fibers during the anagen growth phase. In a
culture of dermal papilla cells in vitro, adenosine stimulated
proliferation and activated and prolonged the anagen phase.
Adenosine also promotes the expression of several growth factors
responsible for hair growth, including fibroblast growth factors
(FGF)-7, FGF-2, insulin-like growth factor (IGF)-1, and vascular
endothelial growth factor (VEGF). β-catenin is a co-activator of
Wnt/β-catenin signaling that induces morphogenesis and
differentiation of hair follicles and also acts to transactivate
downstream signaling pathways. Transcriptional activation of
β-catenin in dermal papilla cells was increased by adenosine.
Double-blind, randomized, placebo-controlled studies of Japanese
men and women confirm adenosine improves androgenic alopecia.
Volunteers used either 0.75% adenosine lotion or a placebo lotion
topically twice daily for 12 months. Adenosine significantly increased
the anagen hair growth rate and hair thickness.
UK-5099
Metabolic reprogramming is necessary for regulating the fate of stem
cell populations. It is now acknowledged that stem cells use a wide
variety of substrates, such as glucose, glutamine, and fatty acids to
support production of biosynthetic intermediates and/or energy during
proliferation or differentiation. Recent findings point to pyruvate as
one of the key metabolites controlling stem cell function. The
metabolic fate of pyruvate, toward lactate production or mitochondrial
metabolism, is a key aspect of the regulation of the stem cell
compartment as it participates in the decision between the
maintenance of self-renewal or the promotion of clonal expansion and
differentiation. Substances regulating pyruvate metabolism are
reported to alter the balance between self-renewal and differentiation
states. UK-5099 is one such substance.
Active Ingredients
©2018 Cellese®. All rights reserved • Irvine, CA 92614 • 1 (877) 350-6350 • www.AnteAGE.com
COPYRIGHT 2018 CELLESE REGENERATIVE THERAPEUTICS
©2018 Cellese®. All rights reserved • Irvine, CA 92614 • 1 (877) 350-6350 • www.AnteAGE.com
COPYRIGHT 2018 CELLESE REGENERATIVE THERAPEUTICS
Caffeine
In cultures of male human hair follicles, caffeine counteracts the
suppression of hair shaft production by testosterone. A study of male
and female scalp hair follicles showed the caffeine effect was even
more pronounced in female hair follicles. In both sexes, caffeine
enhanced hair shaft elongation, prolonged anagen duration and
stimulated hair matrix keratinocyte proliferation.
Caffeine counteracted the testosterone-enhanced TGF-β2 protein
expression seen in male and female hair follicles, enhanced IGF-1
protein expression, stimulated cell proliifer-ation, inhibited
apoptosis/necrosis, and upregulated IGF-1 gene expression and
protein secretion.
Baicalin
The flavonoid baicalin is known to have multiple biological functions
including activation of the Wnt/β-catenin signaling pathway. The hair
growth promoting effects of baicalin in human follicular dermal papilla
cells was studied. Evaluated was its effect on β-catenin signaling and
growth factor expression levels. Results indicated that baicalin
activates Wnt/β-catenin signaling in a dose-dependent manner in
human DP cells and it induces the mRNA expression of growth factors,
such as insulin-like growth factor-1 (IGF-1) and vascular endothelial
growth factor (VEGF). Compared to vehicle treatment, baicalin
treatment induced an earlier conversion from telogen to anagen. The
results strongly suggest that baicalin promotes hair growth by
regulating the dermal papilla cell activity.
Quercetin
Testosterone is necessary for the development of male pattern
baldness (androgenic alopecia) yet the mechanisms for decreased hair
growth are unclear. It is known that prostaglandin D2 synthase and
prostaglandin D2 are elevated in bald scalp compared to haired scalp
of men with androgenic alopecia. Prostaglandin D2 inhibition has been
discovered as a pharmacological mechanism for treating androgenic
alopecia. A study of 12 traditional herbal treatments for baldness
concluded that a common mechanism of action was inhibition of
prostaglandin D2 synthase although most botanicals had unacceptable
side-effects such as skin irritation, sensitization, corrosiveness or poor
absorption. Quercetin in particular shows good pharmacokinetic
properties including anti-inflammatory effect and minimal adverse skin
reaction.
L-Carnitine
The amino acid l-carnitine plays a key role in the intramitochondrial
transport of fatty acids for beta-oxidation and thus serves important
functions in cellular energy metabolism, making supplementation of
potential value by increasing the energy supply in the proliferating and
energy-consuming anagen hair matrix. Hair follicles in the anagen
stage of the hair cycle were cultured in the presence of
l-carnitine-l-tartrate for 9 days. At day 9, treated hair follicles showed a
moderate, but significant stimulation of hair shaft elongation
compared with vehicle-treated controls. Apoptosis was down
regulated, and proliferation up regulated.
Vitamin E Acetate
Studies have shown an association between oxidative stress and
alopecia. Patients with alopecia exhibit lower levels of antioxidants in
their scalp as well as a higher lipid peroxidation index. Tocotrienols
belong to the vitamin E family and are known to be potent
antioxidants. A placebo-controlled study investigated the effect of
tocotrienol supplementation on hair growth in volunteers suffering
from hair loss. The number of hairs in the tocotrienol supplementation
group increased significantly as compared to the placebo group, with
the former recording a 34.5% increase at the end of the 8-month
supplementation as compared to a 0.1% decrease for the latter. This
observed effect was most likely to be due to the antioxidant activity of
tocotrienols that helped to reduce lipid peroxidation and oxidative
stress in the scalp.
Patient Results
Analyses of regenerative wave patterns in adult hair follicle
populations reveal macro-environmental regulation of stem cell
activity. Int J Dev Biol. 2009; 53(5-6): 857–868
Signaling Involved in Hair Follicle Morphogenesis and
Development.
Int J Mol Sci. 2014 Jan; 15(1): 1647–1670.
An integral program for tissue renewal and regeneration: Wnt
signaling and stem cell control.
Science 03 Oct 2014: Vol. 346, Issue 6205
Modulating hair follicle size with Wnt10b/DKK1 during hair
regeneration. Exp Dermatol. 2014 Jun;23(6):407-13.
Distinct functions for Wnt/β-catenin in hair follicle stem cell
proliferation and survival and interfollicular epidermal
homeostasis. Cell Stem Cell. 2013 Dec 5; 13(6): 720–733.
Wnt signals are required for the initiation of hair follicle
development. Dev Cell. 2002 May;2(5):643-53.
Wnt Signaling in Hair Follicle Development. Asian Journal of
Beauty and Cosmetology. 2017; 15. 242-246.
Artepillin C and Other Herbal PAK1-blockers: Effects on Hair Cell
Proliferation and Related PAK1-dependent Biological Function in
Cell Culture. Phytother Res. 2016 Jan;30(1):120-7
Herbal therapeutics that block the oncogenic kinase PAK1: a
practical approach towards PAK1-dependent diseases and
longevity. Phytother Res. 2014 May;28(5):656-72.
Hair Growth Promoting and Anticancer Effects of p21-activated
kinase 1 (PAK1) Inhibitors Isolated from Different Parts of Alpinia
zerumbet. Molecules 2017,22,13
JAK/STAT Signaling. MedChem Express
Adenosine stimulates growth of dermal papilla and lengthens the
anagen phase by increasing the cysteine level via fibroblast
growth factors 2 and 7 in an organ culture of mouse vibrissae hair
follicles. Int J Mol Med. 2012 Feb;29(2):195-201.
Mechanism of action of minoxidil in the treatment of androgenetic
alopecia is likely mediated by mitochondrial adenosine
triphosphate synthase-induced stem cell differentiation. J Biol
Regul Homeost Agents. 2017 Oct-Dec;31(4):1049-1053.
Adenosine increases anagen hair growth and thick hairs in
Japanese women with female pattern hair loss: a pilot,
double-blind, randomized, placebo-controlled trial. J Dermatol.
2008 Dec;35(12):763-7.
Stem Cell Metabolism in Cancer and Healthy Tissues: Pyruvate in
the Limelight. Front. Pharmacol., 04 January 2018
Lactate dehydrogenase activity drives hair follicle stem cell
activation. Nature Cell Biology 14 August 2017
Differential effects of caffeine on hair shaft elongation, matrix and
outer root sheath keratinocyte proliferation, and transforming
growth factor-β2/insulin-like growth factor-1-mediated regulation
of the hair cycle in male and female human hair follicles in vitro. Br
J Dermatol. 2014 Nov;171(5):1031-43.
Baicalin, a flavonoid, affects the activity of human dermal papilla
cells and promotes anagen induction in mice. Naunyn
Schmiedebergs Arch Pharmacol. 2015 May;388(5):583-6.
In silico prediction of prostaglandin D2 synthase inhibitors from
herbal constituents for the treatment of hair loss. J
Ethnopharmacol. 2015 Dec 4;175:470-80.
Prevention and treatment of alopecia areata with quercetin in the
C3H/HeJ mouse model. Cell Stress Chaperones. 2012 Mar; 17(2):
267–274.
Prostaglandin D2 inhibits hair growth and is elevated in bald scalp
of men with androgenetic alopecia. Sci Transl Med. 2012 Mar
21;4(126):126ra34.
L-carnitine-L-tartrate promotes human hair growth in vitro. Exp
Dermatol. 2007 Nov;16(11):936-45.
Effects of Tocotrienol Supplementation on Hair Growth in Human
Volunteers. Trop Life Sci Res. 2010 Dec; 21(2): 91–99.
Herbal Extracts Induce Dermal Papilla Cell Proliferation of Human
Hair Follicles. Ann Dermatol. 2015 Dec;27(6):667-75.
Selected Bibliography

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