GROWTH FACTOR STEM CELL SCIENCES

Skin Care and Hair Care Product Line

FDA DISCLAIMER

THIS MEDICAL AND SCIENTIFIC INFORMATION IS NOT FOR USE CONSUMERS.

THE DIETARY SUPPLEMENT PRODUCTS AND MEDICAL DEVICES OFFERED BY

CELVITALI MEDICAL HAVE NOT BEEN EVALUATED BY THE FDA AND ARE NOT INTENDED FOR USE BY CONSUMERS OR MEDICAL PROVIDERS FOR BILLING PURPOSES NOR AS A MEANS TO CURE, TREAT, PREVENT, DIAGNOSE, OR MITIGATE ANY DISEASE OR OTHER MEDICAL CONDITION.

THIS IS NOT TO BE USED FOR SALES OR MARKETING. THIS IS FOR INTERNAL EDUCATONAL PURPOSES ONLY.

•What are Growth Factors (GF)

• Basic skin anatomy and physiology

• How growth factors can help reverse the aging process

• Product line uses, benefits and applications

Overview

Skin Anatomy

Fitzpatrick Skin Scale – 6 grades

How Smoking Effects Skin

• Low level of collagenproduction

• Nicotine and cadmiumsuppress fibroblastproliferation and hencecollagen production

• Hydrogen cyanide inhibitsoxygen delivery to cells indermal matrix – poor cellfunction

Pre Post

How Smoking Effects SkinVasodilatation &Inflammation

Fibroblast Proliferation &Collagen Production

Collagen Cross-linking &Matrix Maturation

Vasoconstriction

Nicotine

Inhibits Fibroblast Proliferation

And Function

Nicotine & Cadmium

Reduced Tissue Oxygenation& Enzymatic Oxidative

Metabolism

Hydrogen Cyanide

What are Growth Factors

Growth factors are proteins that bind to receptors on the cell membrane surface with the primary function of activating cellular activities.

Many growth factors are quite versatile, stimulating cellular processes in numerous different cell types while others are specific to a particular cell-type.

• Chemical messengers between cells

• Turn a variety of cellular activities “on” and “off”

• Can increase the rate at which cells in the body grow

•Proliferation

• Are involved with signaling new blood vessel growth (angiogenesis) as well as collagen, elastin and fibronectin production and distribution

•ECM – Extra Cellular Matrix (elasticity and resilience)

Functions of Growth Factors

• According to the US National Library of Medicine and the National Center for Biotechnology Information There are over 500 published scholarly articles that discuss the topical application of growth factors in regenerative medicine, wound healing and anti-aging

• The use of skin based growth factors for aged skin has been shown to positively counteract the aging process which includes photo-damage, loss of elasticity, uneven skin tone, and thinning of the epidermis and dermis

Growth Factors in Medicine

How does Science define Growth Factors & Cytokines?

• Growth factors are very specific peptides (proteins) that emit biological signals involved in the regulation of cell growth and function.1,3

• For Example: TGF-b is a potent stimulator of collagen production, promotes the synthesis of extracellular matrix proteins called glycosaminoglycan's (GAG’s), and inhibits extra cellular matrix degradation (thinning of your skin).1,2,3

• Cytokines are associated with immune system cells and play a key role in modulation of inflammation

• For example: PDGF (Platelet-derived growth factors) and GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor), can stimulate extracellular matrix production, reduce inflammation, and promote the formation of new blood vessels.1,3

1. Molecular Aspects of Dermatology. GC Priestley, ed. John Wiley & Sons, NY 19932. Arch Dermatology 138 (11): 1462-70, 20023. Growth Factors and Wound Healing. Ziegler, Pierce, Herndon, ed. Springer-Verlag NY 1997

Function of Cytokines and GF’s

Cytokine Function

TGF-beta Stimulates collagen, elastin and fibronectin production

(b1, b2, b3) Stimulates fibroblast collagen and glycosaminoglycan production

Increases fibronectin synthesis

Inhibits matrix degradation

Facilitates cell chemotaxis (healthy communication environment)

PDGF Stimulates fibroblast collagen and glycosaminoglycan production

Stimulates angiogenesis (new blood vessel growth)

Stimulates wound contraction

Recruits endogenous regenerative cells to region

GM-CSF Improves leukocyte function

Activates neutrophils, eosinophils, and monocytes/macrophages

Recruits endogenous regenerative cells to region

Interleukins Involved with Immunological Functions

(IL-3,IL-6, IL-7, IL-8, and IL-16

Regulate hematopoietic and endothelial cell differentiation and proliferation

Involved with microenvironment homeostasis

Regulate inflammation

Immune cell response to pathogens

Aging of the Skin

• Aging of the skin can be regarded as a cellular process that is partially genetically determined and partially influenced by environmental factors (i.e. sun damage, air pollutants, etc.)

• The most obvious changes in the skin due to aging include: wrinkling, laxity, dryness, and general thinning.

• Prominent wrinkling is mainly caused by the loss of dermal collagen content, and a decreased rate of collagen production. 1 This is a result of decreased growth factor production.

1. Molecular Aspects of Dermatology, GC Priestley, ed. John Wiley & Sons, NY 19932. Arch Dermatology 138 (11): 1462-70, 20023. Growth Factors and Wound Healing, Ziegler, Pierce, Herndon, ed. Springer-Verlag. NY 1997

The Fibroblast

• Dermal fibroblast cells are the "construction workers" of skin. A decline in the number of fibroblast cells results in:

– less collagen production

– decreased concentration levels of growth factors

• Skin loses around 1% of the number of fibroblast cells and 1% of its thickness per year.1

• The rate of decline in fibroblast cell number and function is increased by sun exposure, recent studies have also shown that sun damaged skin has 35% fewer blood capillaries than normal skin3; thus receiving less nutrients and oxygen than normal healthy skin.

1. Molecular Aspects of Dermatology, GC Priestley, ed. John Wiley & Sons, NY 19932. Arch Dermatology 138 (11): 1462-70, 20023. Growth Factors and Wound Healing, Ziegler, Pierce, Herndon, ed. Springer-Verlag. NY 1997

Growth Factors, Stem Cells and Plants… Misconception vs. Fact

• Do Stem cells produce growth factors?

• Are they relevant?

• Why stem cell?

• Do growth factors from other species; e.g. plants work on humans?

• What is the best source of growth factors?

Skin Growth Factors and Cytokines in Summary

• Are very specific peptides (proteins)

• Involved in the communication process between cells and tissues (lock and key)

• They regulate the cell’s growth, replication and regeneration mechanisms (proliferation and differentiation)

• Stimulate the skin’s own renewal mechanism

• Can increase hydration and promote elimination of toxins (angiogenesis)

• Improve elasticity and resilience (ECM production)

• Aid in repairing the look of damaged skin

AreaEpidermis

(mm)

Dermis

(mm)

Total Skin

Thickness (mm)

Forehead 0.1 0.8 0.9

Periorbit

al0.05 0.47 0.53

Cheeks 0.1 1.1 1.2

Chin 0.08 0.75 0.83

Neck 0.1 1.3 1.4

Average Skin Thickness

Note: we show wrinkles around our eyes first; where the skin is thinnest.

Medicine: Wound Healing and Growth Factors

Manufacturing of Growth Factors

• Fibroblast cell line is screened , genetically modified, licensed and patented

• Cells grow in enriched media for pure growth factor production

• Growth factors, cytokines, interleukins and other peptides are produced by the cells

• Growth factors and peptides are harvested and purified from the cell cultures then stored under stringent sterile conditions

• The products are formulated in a sterile environment in a FDA registered facility under GMP to produce the product

Enrich cells for growth factor production

• Are there any studies or published articles on negative effects of topically applied growth factors?

•clear record of safety for 10+ years

•What is the assurance and theory behind safety?

•Growth Factors are naturally found in the body

• They act locally and don’t enter the blood stream

•Paracrine and not Endocrine (hormone)

•Paracrine refers to a hormone that has effect only in the vicinity of the gland secreting it

•US FDA allows the use of GF in cosmetics

•No treatment claim

Safety: are Growth Factors safe for topical application?

Impact of Quality on Results

What difference does it make?

o 94% of women saw improvement in overall appearance of their skin

o 85% experienced improvement in skin texture/smoothnesso 79% felt increase in skin firmness and elasticityo 87% saw reduction in the appearance of fine lines and

wrinkles

Alpha-Hydroxy Acids

• α-Hydroxy acids, or alpha hydroxyacids (AHAs), are a class of chemical compounds that consist of a carboxylic acid substituted with a hydroxyl group on the adjacent carbon.

• May well-known α-hydroxy acids are glycolic acid, lactic acid, citric acid and mandelic acid.

Beta-hydroxy Acids

• A beta hydroxy acid or β-hydroxy acid (BHA) is an organic compound contains a carboxylic acid functional group and functional group separated by two carbon atoms.

• Salicyclic Acid is a well-known beta-hydroxyacid

Restore Cleanser

Product Benefits:

All Skin TypesFor all skin types, this gentle sulfate-free cleanser can be used daily to help refine skin texture and fade discoloration and sun spots.

Restore Cleanser

Active Ingredients:

Aloe Vera - Improves the circulation and regenerates the cells. Its effects are soothing, astringent, and protecting. Aloe is also excellent for sensitive skins, rosacea conditions, and dry skin.

Citrus Aurantium Dulcis (Orange Peel) – An Anti-inflammatory and antibacterial, it is valued for its invigorating, relaxing and lightening abilities.

Olea Europaea (Olive Oil) – A carrier oil that helps stimulate the synthesis of such substances as collagen, elastin, proteoglycans, and glycoproteins over the skins surface.

Tocopheryl (vitamin E) – This wonderful vitamin, when applied topically, is absorbed through the skin. It is attributed with reducing skin pigmentation, decreasing functioning of the sebaceous glands, increasing water retention in the skin, and serving as a super antioxidant and free radical scavenger.

Restore Cleanser

Organic Herbal Infusion, Organic Aloe Barbadensis Leaf Juice (Aloe Vera), Decyl Glucoside, Cocamidopropyl Jydroxysultaine, Cocamidopropyl Betaine(from coconuts), Cocamide MIPA, Sodium Asorbyl Phosphate (Vitamin), Methylsulfonylmethane (MSM), Disodium Laureth Sulfosuccinate, Disodium Lauryl Sulfosuccinate, Carbomer, (2s)-2-Amino-5-guanidinopentanoic acid, Olea Europaea (Olive Oil), Retinyl Palmitate (Vitamin A), Tocopheryl(Vitamin E), Rose Canina (Rose Hip Oil), Borago Officinalis (Borage Oil), Citrus Aurantium Dulcis (Orange Peel Tincture), Origanum Compactum(Oregano Oil), Melaleuca Alternifolia (Tea Tree Oil), Ethylhexyl Glycerin, Phenoxyethenol.

Restore Cleanser

Usage:

Wash face, neck and chest thoroughly with warm water, and pat dry. Follow with toner.

Revitalize Toner

Product Benefits:

An antiseptic toner that removes excess oil, dead cell build up and flaky skin. It helps refine and unclog pores as it clarifies the complexion. This formula contains Salicylic Acid, Witch Hazel Extract, Lemon Peel Extract, Panthenol, Aloe Vera, Sodium Ascorbate, Tocopheryl (Vit.E) and Retinol, (Vit.A).

Exfoliates and clarifies the complexion Dissolves excess oil without over-drying Stimulates and improves circulation Tones

and balances skin

Revitalize Toner

Active Ingredients:

Salicylic AcidThis ingredient aids in dissolving the top layer of the stratum corneum by virtue of its keratolytic nature, or exfoliation. Salicylic Acid is derived from the bark of sweet birch and the leaves of wintergreen. It is also known for its antiseptic qualities and is acceptable for use on most skin types, except those allergic to “aspirin” or extremely dry or extra sensitive skin.

Retinol PalmitateA biologically active form of Vitamin A that can be converted to retinoic acid when applied to the skin. Retinol’s benefits stems from its vital role in theability to produce new cell tissue, maintenance, and optimum cellular function.

Witch Hazel ExtractKnown for its astringent properties. Witch Hazel extract is also toning, anti-inflammatory, and regulating. Derived from the bark and leaves of the tree. It is a proficient vasoconstrictor effect that is excellent for inflamed, irritated or acneic skin conditions. It is also used in ointments for the treatment of sunburns, bruises and insect bites.

PanthenolThis highly moisturizing ingredient aids in tissue repair and stimulates cellular proliferation. Panthenol also helps promote wound healing and is anti-inflammatory. Its ability to attract

water from the environment provides added hydration and suppleness to the skin.

Revitalize Toner Ingredient List

Water, aloe barbadensis leaf juice, sodium hyaluronate, sodium pca, citrus medica limonum(lemon bioflavonoids) peel extract, hemamelisvirginlana (witch hazel) extract, polysorbate 20, hydroxyethyl urea, panthenol, PEG/PPG-9/3 laurate, caprylyl glycol, salicylic acid, caprylic/caprictriglyceride, sodium ascorbate, tocopherol, retinol, Vitamins C, E & A, methylisothiazolinone

Revitalize Toner

Usage:

After cleansing, apply a small amount of toner to a cotton pad

and then to face and neck areas and let dry.

Replenish Growth Factor

Product Benefits:

Formulated with patented growth factor technology, the face serumincludes concentrated proteins, growth factors and active ingredients,that help revitalize the skin to create a firm, youthful lookingcomplexion. When regularly applied topically to the skin, this serum isdesigned to naturally accelerate the skins renewal process by providingthe damaged skin cells with the necessary components of young,healthy skin. These active ingredients aim to stimulate the productionof collagen in the deeper layers of the skin, resulting in improvedelasticity and overall appearance of the skin.

• Diminish deep lines and wrinkles• Firm and tone the skin• Improve the look of skin texture• Create an even skin tone• Fade sun damage

Replenish Growth Factor Serum

Active Ingredients:

Fibroblast Conditioned Media, Water (Aqua), Glycerin, Polysorbate 20, Xanthan Gum, Tetrahexyldecyl, Absorbate, Tacopheryl Acetate, Lactic Acid, Citrus Aurantium, Bergamonia, Phenoxyethenanol, 1,2 Hexanediol, Caprylyl Glycol

l

Replenish Growth Factor Serum

Usage:

• Carefully dispense a small amount of serum onto clean fingers and gently apply over the entire face, neck and chest areas after cleansing and toning. Repeat process twice daily, preferably morning and night. Optimal results are seen after 6 weeks of regular usage.

Rejuvenate Daily Moisturizer

Ingredients:

Aloe VeraKnown for its anti‐inflammatory and antibiotic properties. Aloe Vera is made up of the most precious substances of our own skin‐ enzymes, vitamins, proteins, and minerals that support all skin functions and activate the skins healing power. Aloe Vera helps maintain the skins moisture balance and stimulates blood circulation. It has been used to calm and soothe burns and irritations, and it is moisturizing.

Green Tea Leaf Extract (Camellia Sinensis)This herbal extract is rich in potent antioxidants to protect skin from harmful ultraviolet sunrays. It has astringent properties due to the tannic acid content which helps reduce inflammation and swelling.

Spirulina ExtractSpirulina is a essential glyco-nutrient. It nourishes skin and contains essential fatty acids and vitamins.

Tocopheryl Acetate (Vitamin E)An antioxidant found in vegetable oils and other herbal essential oils. Also known as Vitamin E, this wonderful vitamin, when applied topically, is easily absorbed into the skin. It reduces unwanted skin pigmentation, decreases production of sebaceous gland activity, and increases water retention in the skin. It also serves as a super antioxidant and free radical scavenger. It also

helps protect from harmful UVA/UVB sunrays.

Rejuvenate Daily Moisturizer Ingredient List

Aloe barbadensis leaf juice, palm oil, stearic acid, sweet almond oil, glycerin, citric acid (Vitamin C), retinyl palmitate (Vitamin A), tocopheryl acetate (Vitamin E), cetyl alcohol, stearyl alcohol, glycerylstearate, PEG-100, dimethicone, carbomer, hydroxide, allantoin, phenoxyethanol, methylisothiazolinone

Rejuvenate Daily Moisturizer

Usage:

After cleansing and toning, apply to face and neck areas. May be followed

with a sun protection product.

Repair Growth Factor Eye Serum

Product Benefits:

The Eye Serum is particularly intended to target the delicate area around the eye. The concentrated proteins of the advanced growth factor technology aim to tighten and brighten the skin. The sensitive skin around the eye will appear brighter and more refreshed with this moisturizing formula that helps the broken capillaries causing the dark circles, crow feet and fine lines.

• Lift and tighten skin along outer edges of the eye• Smooth fine lines and sagging skin• Reduce dark circles• Gently moisturizes the skin around the eye

Dark Circles under eyes

• The most effective dark circles eye creams will have advanced powerful ingredients like Hesperidin methyl chalcone, Palmitoyl oligopeptide and Palmitoyltetrapeptide-3. Together these ingredients work to diminish broken blood vessels under the skin which cause dark under eye circles and stimulate collagen production to repair flaws like fine lines and wrinkles.

• Hemosiderin is a pigment that is a byproduct of hemoglobin in the blood that has spread into the tissues following injury with bleeding and bruising of the tissues. It contains iron pigment and may take along time (years) for the body to metabolize the iron and pigment that has spread into the tissues.

Hesperidin methyl chalcone

• Hesperidin is found in naturally high concentrations in the peel, pulp, and membranes of citrus fruit, such as grapefruits, lemons, and oranges. Hesperidin methyl chalcone has antioxidant properties, which help it to combat the inflammation and cell damage caused by free radicals.

• Hesperidin helps to reduce tiny blood vessels in the skin around your eyes from breaking and leaking. This leakage causes dark bruises or what you know as dark circles.

Palmitoyl oligopeptide and Palmitoyl tetrapeptide-3

• Synthetically produced peptides comprised of four amino acids that are to suppress the production of excess interleukins, the chemical messengers which trigger the body’s acute inflammatory response.

• These peptides work to stimulate collagen production in the skin. Increased collagen production helps diminish fine lines and wrinkles around the eye area. Skin is younger and smoother looking.

Retinyl palmitate

• This retinoid is a form of Vitamin A that works to speed up the metabolism of the skin cells. It helps regenerate new skin cell growth which leads to radiant and rejuvenated skin.

Chrysin

• Chrysin is an naturally occurring isoflavone that is extracted from plants, most often from the passiflora caerulea (blue passion flower).

• Chrysin is an anti-oxidant and anti-inflammatory. It works as a vasodiolator; which helps increase proper blood flow around the eye. This helps prevent blood vessels from breaking and bruising and also enhances the effects of hesperidin.

Repair Growth Factor Eye Complex

Active Ingredients:

Water (Aqua), Fibroblast Conditioned Media, Acetyl Hexapeptide-8, Glycerin, Hesperidin Methyl Chiacone, Steareth-20, Dipeptide-2, Palmitolyl Tetrapeptide-7, Butylene Glycol, Oenthera Biennis (Evening Primrose), Seed Extract, Polysorbate 20, Chrysin, N-HydroxySuccinimide, Palmitoyl Oligopeptide, Amino ethyl-phosphinic Acid, Xanthan Gum, Carmelia Sinesis(Green Tea), Leaf Extract, Citrus Aurantium, Bergania(Bergamot) Fruit Oil, Phenoxyethanol, 1,2 Hexanediol, Caprylyl Glycol

Repair Growth Factor Eye Complex

Usage:

• Carefully dispense a small amount of serum onto clean fingers. With gentle pressure, apply serum using a circular motion around the entire eye area until the serum is absorbed. Repeat process twice daily, preferably morning and night. Optimal results are seen after 6 weeks of regular usage.

Regenerate Night Cream

Product Benefits:

• This lush moisturizer is ideal for all skin types. Enriched with Aloe and infused with Olive and Jojoba oils, this moisturizer glides on for long-lasting softness.

Regenerate Night Cream

Active Ingredients:

Aloe Vera - Improves the circulation and regenerates the cells. Its effects are soothing, astringent, and protecting. Aloe is also excellent for sensitive skins, rosacea conditions, and dry skin.

Olea Europaea (Olive Oil) – A carrier oil that helps stimulate the synthesis of such substances as collagen, elastin, proteoglycans, and glycoproteins over the skins surface.

Jojoba Oil – Beneficial to help treat dry or oily skin. If your skin has an over production of sebum jojoba oil will dissolve clogged pores and restore the skin to its natural pH balance. Helps reduces superficial lines, wrinkles and is hypoallergenic and pure.

Sweet Almond Oil – An easily absorbable oil that is suitable for all skin types, helps relieve irritation, inflammation and itching. Known for its ability to soften and re-condition the skin. It is rich in proteins and Vitamin D, and is considered extremely nourishing.

Tocopheryl (vitamin E) – This wonderful vitamin, when applied topically, is absorbed through the skin. It is attributed with reducing skin pigmentation, decreasing functioning of the sebaceous glands, increasing water retention in the skin, and serving as a super antioxidant and free radical scavenger.

Regenerate Night Cream Ingredient List

Organic Herbal Infusion, Organic Aloe Barbadensis (Aloe Vera), Isopropyl Palmitate (Palm Oil), Kosher Vegetable Glycerin, Cetyl Alcohol, Stearic Acid Glyceryl Stearate, Organic Carthamus Tinctorius (Safflower Oil), PrunusAmygdalus Dulcis (Sweet Almond Oil), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, (2s)-2-Amino-5-Guanidinopentanoic Acid, Butyrospermum Parkil (Shea Butter), Olea Europaea (Olive Oil), Organic SimmondsiaChinesis (Jojoba Oil), Pathenol (Vitamin B5), Phenoxyethanol, Ethylhexyl Glycerin, Xanthan Gum, Allantoin, Tocopheryl (Vitamin E), Retinyl Palmitate(Vitamin A), Organic Camellia Sinesis (Green Tea), Citric Acid

Regenerate Night Cream

Usage:

After cleansing and toning, apply a small amount to entire face and neck. May be used twice daily if desired.

FDA DISCLAIMER

THIS MEDICAL AND SCIENTIFIC INFORMATION IS NOT FOR USE CONSUMERS.

THE DIETARY SUPPLEMENT PRODUCTS AND MEDICAL DEVICES OFFERED BY

CELVITALI MEDICAL HAVE NOT BEEN EVALUATED BY THE FDA AND ARE NOT INTENDED FOR USE BY CONSUMERS OR MEDICAL PROVIDERS FOR BILLING PURPOSES NOR AS A MEANS TO CURE, TREAT, PREVENT, DIAGNOSE, OR MITIGATE ANY DISEASE OR OTHER MEDICAL CONDITION.

THIS IS NOT TO BE USED FOR SALES OR MARKETING. THIS IS FOR INTERNAL EDUCATONAL PURPOSES ONLY.

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