DESC:A KERATOGROW COMPOSITION FOR REDUCING HAIR FALL AND STIMULATING HAIR GROWTH
FIELD OF THE INVENTION
The present information relates to a keratogrow formulation and more particularly to the keratogrow formulation to reduces hair fall and stimulates hair growth.
BACKGROUND OF THE INVENTION
Hair fall is a common problem. The hair fall occurs when the normal cycle of hair growth and shedding is disrupted or when one or more hair follicles are destroyed. The cause of hair loss involves one or more factors, such as, family history (heredity), hormonal changes, medical conditions, and medications.
EP2437596A1 titled as “skin treatment compositions” discloses compositions, kits and methods for treating skin. The composition can be a topical skin treatment composition that includes polyethylene glycol (PEG), triclosan, one or more of a salicylate, bronopol, and an acrylic emulsion, and, optionally, a solvent. The composition further includes benzalkonium chloride and amoxicillin.
US20040171693A1 titled as “method for increasing hair growth” disclosed a method for stimulating hair follicle growth, which comprises applying a composition containing a follicle stimulating effective amount of a creatine compound. The composition further includes PEG and ATP.
CA2664697A1 titled as “Methods, kits, and compositions for generating new hair follicles and growing hair” discloses methods, kits, and compositions for generating new hair on a subject. The composition further includes PEG, ATP and benzalkonium chloride.
None of the above mentioned prior art discloses the novelty and obviousness of the present invention and hence there is need for the present invention.
SUMMARY OF THE PRESENT INVENTION
The present information relates to a keratogrow formulation and more particularly to the keratogrow formulation reduces hair fall and stimulates hair growth.
The keratogrow formulation includes a polyethylene glycol (PEG), a benzalkonium chloride (BKC), an amoxicillin, a placentrix, a stem cell growth factor concentrate or extrudate and an adenosine triphosphate (ATP). The concentration of the adenosine triphosphate (ATP) in the formulation is selected from a range of, but not limited to, 0.5mM to 5mM. The concentration of the polyethylene glycol (PEG) in the formulation is selected from a range of, but not limited to, 2mM to 12mM. The concentration (v/v) of the benzalkonium chloride (BKC) in the formulation is selected from a range of, but not limited to, 0.5% to 5.0%. The concentration of the amoxicillin in the formulation is selected from a range of, but not limited to, 100mg to 1000mg. The concentration (v/v) of the placentrix in the formulation is selected from a range of, but not limited to, 0.1% to 15%.
One advantage of the present invention is to provide the keratogrow formulation for reducing hair fall and stimulating hair growth.
Another advantage of the present invention is to provide the keratogrow formulation for quick recovery of wounds, cuts, burns, ulcers, diabetic foot, and post operative wounds, an injury during a FUE and a FUT hair transplants.
Yet another advantage of the present invention is to promote hair and skin regeneration.
Further objectives, advantages and features of the present invention will become apparent from the detailed description provided herein below, in which various embodiments of the disclosed invention are illustrated by way of example and appropriate reference to accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention can be understood in more detail by reading the subsequent detailed description in conjunction with the examples and references made to the accompanying drawings, wherein:
Fig. 1 illustrates a tabular representation of measurement of density of a hair fiber counts per cm2 for the patients without the keratogrow treatment (control) of the example 1 of the present invention.
Fig. 2 illustrates a graphical representation of measurement of density of the hair fiber counts for the patients without the keratogrow treatment (control) of the example 1 of the present invention.
Fig. 3 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 for the patients treated with the keratogrow treatment of the example 1 of the present invention.
Fig. 4 illustrates a graphical representation of measurement of density of the hair fiber counts for the patients treated with the keratogrow treatment of the example 1 of the present invention.
Fig. 5 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 in patients treated with and without the keratogrow treatment of the example 1 of the present invention.
Fig. 6 illustrates a graphical representation of a measurement of density of the hair fiber counts per cm2 in patients treated with and without the keratogrow treatment of the example 1 of the present invention.
Fig. 7 illustrates a tabular representation of measurement of rate of hair loss per day during 0 month, 3 months and 6 months for the patients without the keratogrow treatment (control) of the example 2 of the present invention.
Fig. 8 illustrates a graphical representation measurement of rate of hair loss for the patients without the keratogrow treatment (control) of the example 2 of the present invention.
Fig. 9 illustrates a tabular representation of measurement of rate of hair loss per day during 0 month, 3 months and 6 months for the patients with the keratogrow treatment (control) of the example 2 of the present invention.
Fig. 10 illustrates a graphical representation of measurement of rate of hair loss for the patients treated with the keratogrow treatment of the example 2 of the present invention.
Fig. 11 illustrates a tabular representation of measurement of rate of hair loss with and without the keratogrow treatment of the example 2 of the present invention.
Fig. 12 illustrates a graphical representation of measurement of rate of hair loss before and after the keratogrow treatment of the example 2 of the present invention.
Fig. 13 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 for the patients without the keratogrow treatment (control) of the example 3 of the present invention.
Fig. 14 illustrates a graphical representation of measurement of density of the hair fiber counts for the patients without the keratogrow treatment (control) of the example 3 of the present invention.
Fig. 15 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 for the patients treated with the keratogrow treatment of the example 3 of the present invention.
Fig. 16 illustrates a graphical representation of measurement of density of the hair fiber counts for the patients treated with the keratogrow treatment of the example 3 of the present invention.
Fig. 17 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 in patients treated with and without the keratogrow treatment of the example 3 of the present invention.
Fig. 18 illustrates a graphical representation of final data of measurement of density of the hair fiber counts before and after the keratogrow treatment of the example 3 of the present invention.
Fig. 19 illustrates a tabular representation of measurement of rate of hair loss per day during 0 month, 3 months and 6 months for the patients without the keratogrow treatment (control) of the example 4 of the present invention.
Fig. 20 illustrates a graphical representation measurement of rate of hair loss for the patients without the keratogrow treatment (control) of the example 3 of the present invention.
Fig. 21 illustrates a tabular representation of measurement of rate of hair loss per day during 0 month, 3 months and 6 months for the patients with the keratogrow treatment (control) of the example 4 of the present invention.
Fig. 22 illustrates a graphical representation of measurement of rate of hair loss for the patients treated with the keratogrow treatment of the example 4 of the present invention.
Fig. 23 illustrates a tabular representation of measurement of rate of hair loss per day during 0 month, 3 months and 6 months for the patients treated with and without the keratogrow treatment of the example 4 of the present invention.
Fig. 24 illustrates a graphical representation of measurement of rate of hair loss before and after the keratogrow treatment of the example 4 of the present invention.

DETAILED DESCRIPTION OF THE INVENTION
While this invention is susceptible to embodiment in many different forms, there is shown in the drawings and will herein be described in detail specific embodiments, with the understanding that the present disclosure of such embodiments is to be considered as an example of the principles and not intended to limit the invention to the specific embodiments shown and described. In the description below, like reference numerals are used to describe the same, similar or corresponding parts in the several views of the drawings. This detailed description defines the meaning of the terms used herein and specifically describes embodiments in order for those skilled in the art to practice the invention.
Definition
The terms “a” or “an”, as used herein, are defined as one or as more than one. The term “plurality”, as used herein, is defined as two or as more than two. The term “another”, as used herein, is defined as at least a second or more.
The term “comprising” or “including” or “containing” or “having” is not intended to limit inventions to only claiming the present invention with such comprising language. The term “comprising” can be used interchangeably used by the terms “having” or “containing”. The drawings featured in the figures are for the purpose of illustrating certain convenient embodiments of the present invention, and are not to be considered as limitation thereto.
As used herein, the term “hair” generally refers to, but not limited to a protein filament that grows from follicles found in the dermis, or skin. Each strand of hair is made up of the medulla, cortex, and cuticle. Hair growth begins inside the hair follicle. The only "living" portion of the hair is found in the follicle. The hair that is visible is the hair shaft, which exhibits no biochemical activity and is considered "dead". The base of a hair's root (the "bulb") contains the cells that produce the hair shaft. One or more stem cells are responsible for hair production.
As used herein, the term "pharmaceutical composition" generally refers to, but not limited to, a composition that is pharmaceutically acceptable.
As used herein, the term "pharmaceutically acceptable" generally refers to, but not limited to, those compounds, materials, compositions, and/or dosage forms which are, within the scope of sound medical judgment, suitable for contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem complications commensurate with a reasonable benefit/risk ratio.
As used herein, the term “pharmaceutical formulations” generally refers to, but not limited to, the process in which various kinds of chemical substances and active drugs are combined to produce a final medicinal product. The formulation type includes, but not limited to, tablets or capsules, cream, ointment, gel, paste, powder, spray, injections.
As used herein, the term "adenosine triphosphate (ATP)" generally refers to, but not limited to, a nucleotide that consists of three main structures: a nitrogenous base, an adenine; a sugar, a ribose; and a chain of three phosphate groups bound to ribose. The phosphate tail of the adenosine triphosphate (ATP) is the actual power source which the cell. Available energy is contained in the bonds between the phosphates and is released when they are broken. Usually only the outer phosphate is removed from the adenosine triphosphate (ATP) to yield energy.
As used herein, the term “polyethylene glycol” generally refers to, but not limited to, a synthetic polyether that is available in a range of molecular weights. The term “polyethylene glycol” is interchangeably used by “PEG”, poly(oxyethylene) or poly(ethylene oxide). Materials with MW<100,000 are usually called PEGs. These polymers are amphiphilic and soluble in water as well as in many organic solvents (e.g., methylene chloride, ethanol, toluene, acetone, and chloroform). The polyethylene glycol (PEG) has been found to be nontoxic and is approved by the FDA for use as excipients or as a carrier in different pharmaceutical formulations, foods, and cosmetics.
As used herein, the term “benzalkonium chloride (BKC)” generally refers to, but not limited to, a quaternary ammonium antiseptic and disinfectant with actions and uses similar to those of other cationic surfactants. The benzalkonium chloride (BKC) is also used as an antimicrobial preservative for pharmaceutical products. The benzalkonium chloride (BKC) being used in ophthalmic solutions at a 39 concentration of 0.01-0.02%. The benzalkonium chloride (BKC) is an effective bactericidal and fungicidal agent that helps to minimize the growth of organisms in multidose containers.
As used herein, the term “normal saline” generally refers to 0.9% sodium chloride solution. The normal saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. A pH of normal saline is in a range of 4.5 to 7.0.
As used herein, the term "weight per volume” or “(w/v)" generally refers to, but not limited to, the relationship of a solute to a solvent expressed as grams of solute per milliliter of the total solution.
As used herein, the term "volume per volume” or “(v/v)" generally refers to, but not limited to, a measure of concentration of a substance in solution expressed as the ratio of the volume of the solution to the total volume of the solution multiplied by 100%.
As used herein, the term "amoxicillin” generally refers to, but not limited to, a semi-synthetic penicillin closely related to an ampicillin and with similar properties. The amoxicillin includes, but not limited to, a penicillin, an ampicillin, an erythromycin, a streptomycin, a sulphonamide, a tetracycline, a sulfa drug, a wonder drug, an amoxil, a larotid, a polymox, an augmentin. The amoxicillin is also spelled as an amoxicillin.
As used herein, the term “cell” generally refers to, but not limited to, a basic structural, functional, and biological unit of living organisms. The cell is selected from, but not limited to, a salivary gland cell, a von ebner's gland cell, a mammary gland cell, a lacrimal gland cell, a ceruminous gland cell in ear, an eccrine sweat gland dark cell, an eccrine sweat gland clear cell, an apocrine sweat gland cell, a gland of moll cell in eyelid, a sebaceous gland cell (lipid-rich sebum secretion), a bowman's gland cell in nose, a brunner's gland cell, a seminal vesicle cell, a prostate gland cell, a bulbourethral gland cell, a bartholin's gland cell, a gland of littre cell, an uterus endometrium cell, an isolated goblet cell of respiratory and digestive tracts, a stomach lining mucous cell, a gastric gland zymogenic cell, a gastric gland oxyntic cell, a pancreatic acinar cell, a paneth cell of small intestine, a type II pneumocyte of lung, a clara cell of lung, an anterior pituitary cell, an intermediate pituitary cell, secreting melanocyte-stimulating hormone, a agnocellular neurosecretory cell, a gut and respiratory tract cell, a thyroid gland cell, a parathyroid gland cell, an adrenal gland cell, a leydig cell of testes secreting testosterone, a theca interna cell of ovarian follicle secreting estrogen, a corpus luteum cell of ruptured ovarian follicle secreting progesterone, a juxtaglomerular cell (renin secretion), a macula densa cell of kidney, a peripolar cell of kidney, a mesangial cell of kidney, an inner pillar cell of organ of corti, an outer pillar cell of organ of corti, an inner phalangeal cell of organ of corti, an outer phalangeal cell of organ of corti, a border cell of organ of corti, a hensen cell, a vestibular apparatus supporting cell, a taste bud supporting cell, an olfactory epithelium supporting cell, a schwann cell, a satellite glial cell, an enteric glial cell, an astrocyte, a neuron cells, an oligodendrocyte, a spindle neuron, an anterior lens epithelial cell, a crystalline containing lens fiber cell, a hepatocyte, an adipocytes, a liver lipocyte, a kidney parietal cell, a kidney glomerulus podocyte, a kidney proximal tubule brush border cell, a loop of henle thin segment cell, a kidney distal tubule cell, a kidney collecting duct cell, a pancreatic duct cell, a nonstriated duct cell, a duct cell, an intestinal brush border cell, an exocrine gland striated duct cell, a gall bladder epithelial cell, a ductulus efferens nonciliated cell, an epididymal principal cell, an epididymal basal cell, an ameloblast epithelial cell, a planum semilunatum epithelial cell, an organ of corti interdental epithelial cell, a loose connective tissue fibroblasts, a corneal fibroblasts, a tendon fibroblasts, a bone marrow reticular tissue fibroblasts, a nonepithelial fibroblasts, a pericyte, a nucleus pulposus cell of intervertebral disc, a cementoblast/cementocyte, an odontoblast/odontocyte, a hyaline cartilage chondrocyte, a fibrocartilage chondrocyte, an elastic cartilage chondrocyte, an osteoblast/osteocyte, an osteoprogenitor cell, an epidermal keratinocyte , an epidermal basal cell, a keratinocyte of fingernails and toenails, a nail bed basal cell, a medullary hair shaft cell, a cortical hair shaft cell, a cuticular hair shaft cell, a cuticular hair root sheath cell, a hair root sheath cell of huxley's layer, a hair root sheath cell of henle's layer, a external hair root sheath cell, a hair matrix cell, a surface epithelial cell of stratified squamous epithelium of cornea, tongue, oral cavity, esophagus, anal canal, distal urethra and vagina, a basal cell (stem cell) of epithelia of cornea, tongue, oral cavity, esophagus, anal canal, distal urethra and vagina, an urinary epithelium cell, an auditory inner hair cell of organ of corti, an auditory outer hair cell of organ of corti, a basal cell of olfactory epithelium, a cold-sensitive primary sensory neurons, a heat-sensitive primary sensory neurons, a merkel cell of epidermis, an olfactory receptor neuron, a pain-sensitive primary sensory neurons, a photoreceptor cells of retina in eye, a proprioceptive primary sensory neurons, a touch-sensitive primary sensory neurons, a type I carotid body cell, a type II carotid body cell, a type I hair cell, a type II hair cell, a type I taste bud cell, a cholinergic neural cell, an adrenergic neural cell, a peptidergic neural cell. More preferably the cell is the stem cell.
As used herein, the term “stem cells” generally refers to, but not limited to, undifferentiated biological cells that can differentiate into specialized cells and can divide through mitosis to produce more stem cells.
As used herein, the term “tissue” generally refers to, but not limited to, an ensemble of similar cells from the same origin that together carries out a specific function. The tissue are selected from, but not limited to, a connective tissue, a muscle tissue, a nervous tissue, an epithelial tissue, a mineralized tissue, a meristematic tissue, a permanent tissue, a simple tissue, a parenchyma, a collenchyma, a sclerenchyma, an epidermis, a xylem, a phloem.
As used herein, the term “follicle” generally refers to, but not limited to, a small spherical group of cells containing a cavity. The follicle is selected from, a dental follicle, a hair follicle, a lymph follicle, an ovarian follicle, a thyroid follicle. More preferably, the follicle is a hair follicle.
As used herein, the term "hydrogel" generally refers to, but not limited to network of polymer chains that are hydrophilic, sometimes found as a colloidal gel in which water is the dispersion medium. The hydrogels also possess a degree of flexibility very similar to natural tissue, due to their significant water content.
As used herein, the term "collagen" generally refers to, but not limited to main structural protein in the extracellular space in the various connective tissues in animals. The collagen is most abundant protein in mammals.
As used herein, the term "extracellular matrix (ECM)" generally refers to, but not limited to collection of an extracellular molecules secreted by cells for providing structural and biochemical support to the surrounding cells. The composition of ECM varies between multicellular structures.
As used herein, the term "follicular unit transplantation (FUT)" generally refers to, but not limited to a hair restoration technique where a patient's hair is transplanted in naturally occurring groups of 1 to 4 hairs, called the follicular units. In the follicular unit transplantation these small units allow the surgeon to safely transplant thousands of grafts in a single session.
As used herein, the term "follicular unit extraction (FUE)" generally refers to, but not limited to, individual the follicular unit extraction directly from the hair restoration patient's donor area, ideally one at a time.
As used herein, the term "allogeneic" generally refers to, but not limited to cells or tissue taken from different individuals of the same species.
As used herein, the term "autologous" generally refers to, but not limited to a situation in which the donor and recipient are the same person. The autologous graft is a graft (such as a graft of skin) that is provided for oneself.
As used herein, the term "peripheral blood" generally refers to, but not limited to the peripheral blood cells that are the cellular components of blood, consisting of a red blood cells (erythrocytes), a white blood cells (leucocytes), and a platelets, which are found within the circulating pool of blood and not sequestered within a lymphatic system, a spleen, a liver, or a bone marrow.
As used herein, the term "cord blood" generally refers to, but not limited to an umbilical cord blood is blood that remains in the placenta and in the attached the umbilical cord after childbirth.
As used herein, the term "placentrix" generally refers to, but not limited to a drug containing peptides (FNP-III, CRF), nucleotides (PDRN, NADPH) & a glutamate and is derived from an extract of fresh term, healthy, human placenta.
As used herein, the term "passage" generally refers to, but not limited to transferring some or all cells from a previous culture to fresh growth medium.
As used herein, the term "mesenchymal stem cells" generally refers to, but not limited to a multipotent stromal cells that can differentiate into a variety of cell types.
As used herein, the term "flash freeze" generally refers to, but not limited to freeze (food or other material) very rapidly so as to prevent the formation of ice crystals.
As used herein, the term "confluency" generally refers to, but not limited to estimate of the number of adherent cells in a culture dish or a flask, referring to the proportion of the surface which is covered by cells.
As used herein, the term "lysate" generally refers to, but not limited to a preparation containing the products of lysis of cells.
As used herein, the term "mononuclear cell" generally refers to, but not limited to any peripheral blood cell having a round nucleus.
As used herein, the term "human serum" generally refers to, but not limited to serum albumin found in human blood.
As used herein, the term "bone marrow" generally refers to, but not limited to a flexible tissue in the interior of bones.
As used herein, the term "laminar air flow" generally refers to, but not limited to a streamline flow which occurs when a fluid flows in parallel layers, with no disruption between the layers. At low velocities, the fluid tends to flow without lateral mixing, and adjacent layers slide past one another like playing cards. There are no cross-currents perpendicular to the direction of flow, nor eddies or swirls of fluids.
As used herein, the term "isopropanol" generally refers to, but not limited to a compound with the chemical formula C3H8O or C3H7OH or CH3CHOHCH3 (sometimes represented as i-PrOH). The isopropanol is a colorless, flammable chemical compound with a strong odor. As a propyl group linked to a hydroxyl group, the isopropanol is the simplest example of a secondary alcohol, where the alcohol carbon atom is attached to two other carbon atoms. The isopropanol has a wide variety of industrial and household uses.
As used herein, the term "biosafety hood" generally refers to, but not limited to an enclosed, ventilated laboratory workspace for safely working with materials contaminated with (or potentially contaminated with) pathogens requiring a defined biosafety level. Several different types of BSC exist, differentiated by the degree of bio-containment required.
As used herein, the term "centrifuge tube" generally refers to, but not limited to a cylinder-shaped, calibrated glass container that fit into centrifuge slots for the analysis and separation of various materials.
As used herein, the term "falcon tube" generally refers to, but not limited to a plastic test tubes with a screw top cap.
As used herein, the term "water bath" generally refers to, but not limited to laboratory equipment made from a container filled with heated water. The water bath is used to incubate samples in water at a constant temperature over a long period of time. All water baths have a digital or an analogue interface to allow users to set a desired temperature. Utilizations include warming of reagents, melting of substrates or incubation of cell cultures.
As used herein, the term "cell strainer" generally refers to, but not limited to a color-coded device that fit onto conical and other types of test tubes in order to isolate primary cells and obtain uniform, single-cell suspensions. The cell strainer is intended to replace gauze filtration in cell dissociation.
As used herein, the term "centrifugation" generally refers to, but not limited to a process which involves the application of the centripetal force for the sedimentation of heterogeneous mixtures with a centrifuge, and is used in industrial and laboratory settings. This process is used to separate two miscible substances, but also to analyze the hydrodynamic properties of macromolecules. More-dense components of the mixture migrate away from the axis of the centrifuge, while less-dense components of the mixture migrate towards the axis. Chemists and biologists may increase the effective gravitational force on a test tube so as to more rapidly and completely cause the precipitate (pellet) to gather on the bottom of the tube. The remaining solution (supernatant) may be discarded with a pipette.
As used herein, the term "what man filter paper" generally refers to, but not limited to a semi-permeable paper barrier placed perpendicular to a liquid or air flow. The what man filter paper is used to separate fine substances from liquids or air.
As used herein, the term "minimal essential medium" generally refers to, but not limited to a cell culture medium that can be used to maintain cells in tissue culture.
As used herein, the term "albumin" generally refers to, but not limited to a main protein of human blood plasma.
As used herein, the term "adipose tissue" generally refers to, but not limited to a loose connective tissue composed mostly of adipocytes.
As used herein, the "amino acid" generally refers to, but not limited to organic compounds containing amine (-NH2) and carboxylic acid (-COOH) functional groups.
As used herein, the term "lyophilized" generally refers to, but not limited to conversion of water from a frozen state to a gaseous state without going through a liquid state.
As used herein, the term "DMEM" generally refers to, but not limited to a modification of basal medium eagle (BME) that contains a four-fold higher concentration of amino acids and vitamins, as well as additional supplementary components.
As used herein, the term "xenogeneic" generally refers to, but not limited to a relating to or involving tissues or cells belonging to individuals of different species.
As used herein, the term "platelet rich plasma" generally refers to, but not limited to a blood plasma that has been enriched with platelets. As a concentrated source of an autologous platelets, the platelet rich plasma contains (and releases through degranulation) several different growth factors and other cytokines that stimulate healing of bone and soft tissue.
The present invention provides a keratogrow formulation including a polyethylene glycol (PEG), a benzalkonium chloride (BKC), an amoxicillin, a placentrix and an adenosine triphosphate (ATP). The concentration of the adenosine triphosphate (ATP) in the formulation is selected from a range of, but not limited to, 0.5mM to 5mM, more preferably the concentration of the adenosine triphosphate (ATP) in the solution is 2mM. The concentration of the polyethylene glycol (PEG) in the formulation is selected from a range of, but not limited to, 2mM to 12mM, more preferably the concentration of the polyethylene glycol (PEG) in the solution is 8mM. The concentration (v/v) of the benzalkonium chloride (BKC) in the formulation is selected from a range of, but not limited to, 0.5% to 5.0%, more preferably the concentration (v/v) of the benzalkonium chloride (BKC) in the solution is 1.5%. The concentration of the amoxicillin in the formulation is selected from a range of, but not limited to; 100mg to 1000mg, more preferably concentration of the amoxicillin in the solution is 500mg. The concentration (v/v) of the placentrix in the formulation is selected from a range of, but not limited to, 0.1% to 15%, more preferably concentration (w/v) of the placentrix in the solution is 4%.
Another embodiment of the present invention provides a formulation for 500ml of the keratogrow. The 500ml the keratogrow includes 7.5ml of the benzylkonium chloride (1.5%), 200ul of the adenosine triphosphate (ATP) solution (2mM), 2ml of the polyethylene glycol (PEG) (8mM), 2 tablets in 1 bottle of amox (500mg) and 1 vial in 1 bottle of placentrix.
Yet another embodiment of the present invention provides the keratogrow formulation including 2mM of an adenosine triphosphate (ATP), 8mM of a polyethylene glycol (PEG) 400, 0.2% (w/v) of the of an amoxicillin, 1.5% (v/v) of a benzalkonium chloride (BKC), the 4% (v/v) of a placentrix.
The adenosine triphosphate (ATP) has classically been considered as the cells primary energy currency. The polyethylene glycol (PEG) has limited toxicity to the cells and is used for the effective delivery of the adenosine triphosphate (ATP) to the cells. The benzalkonium chloride (BKC) works as a topical antiseptic and keeps the adenosine triphosphate (ATP) solution away from any microbial contaminations. The placentrix provides anti-inflammatory and anti-aging properties. The placentrix improves blood flow, hormone levels and tissue regeneration to allow for wound healing with minimal scars. The placentrix acts as a biogenic stimulator, stimulates metabolic and regenerative process, increases blood circulation, tissue metabolism. The placentrix reduces hair fall and stimulates hair growth.
The keratogrow formulation is, but not limited to, a cosmetic topical application or a medicated topical application. The keratogrow formulation present in form of, but not limited to, liquid formulation, spray formulation, gel formulation. The gel form of keratogrow formulation is formed by mixing the hydrogel and the collagen or the ECM proteins. The keratogrow formulation is a stabilized autologus or allogenic human growth factor concentrate. The keratogrow formulation is pharmaceutically acceptable. The synergetic effect of the keratogrow formulation reduces hair fall and stimulates hair growth efficacy.
The present invention further relates to the autologous keratogrow grow production method. The production method is carried out under a laminar air flow in a clean room class 10000. An isolation procedure is carried out in a CGMP compliant clean room. The production method includes steps, but not limited to, wiping out the entire inner surface of a biosafety hood with 70% isopropanol; transferring aspirated 20ml peripheral blood (PB) sample at 50ml centrifuge tube; centrifugating at 3000rpm for 10 minutes; aspirating the platelet rich plasma (PRP) layer into one 15ml falcon tube; heating the platelet rich plasma (PRP) using a water bath for 30 min at 60°C; passing the platelet rich plasma PRP through a cell strainer (100?m) to remove precipitate after 30 minutes; centrifugating at 1200 rpm for 10 min; transferring a supernatant into the 50ml falcon tube containing the mixture of 40ml normal saline, 2mM of an adenosine triphosphate (ATP), 8mM of a polyethylene glycol (PEG), and 1.5% of a benzalkonium chloride (BKC) & 250mg amoxicillin trihydrate capsule making the volume 50ml; mixing properly and autoclaving the entire mixture for 45 min at 121°C; passing through the grade 1 what man filter paper after cooling; transferring the mixture into a 50ml keratogrow bottle; sealing and labeling the keratogrow bottle; storing the keratogrow bottle in 37°C; packing and distributing the keratogrow bottle. A quality control testing including sample sterility testing and infectious disease testing is done for the keratogrow formulation in microbiology lab. The above mentioned steps are also performed interchangeably and order defined does not limit the method of production of keratogrow.
The keratogrow formulation is generally made from, but not limited to the peripheral blood derived growth factors, the placental blood derived growth factors, and the cord blood derived growth factors, the stem cells, or the platelets. Raw tissue like bone marrow, cord blood or adipose tissue is collected from donors after following institutional ethics committee approval and with donor consent forms. The tissue is processed to collect raw stem cells. The stem cells (mononuclear cells MNCs) are cultured in a defined serum free culture media, without any xenogenic components. The media contain; a platelets lysate, a human serum, an albumin, a minimal essential media, a DMEM, an amino acids etc. The cells are allowed to attach to the culture flask, plate surface and propagated to attain a mesenchymal stem cell primary culture. The stem cells are allowed to grow up to 75% to 80% confluency and the spent media is harvested. This is also be done up to P4 (passage 4). The spent media is collected in sterile containers and lyophilized the protein growth factor concentrate. In some methods, the cultured cells are also harvested and lysed with flash freezing and thawing in liquid nitrogen to obtain growth factors important for skin and hair rejuvenation/regeneration.
The keratogrow formulation strengthens existing hair at the root and shaft while also stimulating decaying follicles to begin growing new hairs once again. The keratogrow formulation widens the hair follicles, strengthens the hair roots and thickens the sheath of each hair follicle to restore previously lost hair and protect each existing hair internally.
One advantage of the present invention is to provide the keratogrow formulation for reducing hair fall and stimulating hair growth.
Another advantage of the present invention is to provide the keratogrow formulation for quick recovery of wounds, cuts, burns, ulcers, diabetic foot, and post operative wounds, a FUE and a FUT hair transplants.
Yet another advantage of the present invention is to promote hair and skin regeneration.
Example 1
An experiment was conducted as (Phase-I trial) to measure the density of the hair fiber counts in one or more androgenetic alopecia patients with and without the keratogrow treatment. The control generally refers to measuring the hair fiber count in the androgenetic alopecia without the keratogrow treatment. The follicular density at a calibrated distance from the mid-pupillary point in a 1cm x 1cm square was measured using digital photographs taken at 0 month, 3 months, and 6 months follow up visits after the keratogrow treatment. Hair density indices were compared using a trichoscope with photographs from similar area on different subjects without the keratogrow treatment.
Fig. 1 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 for the patients without the keratogrow treatment (control). The period of observation used for the measurement was 0 months, 3 months and 6 months.
Fig. 2 illustrates a graphical representation of measurement of density of the hair fiber counts for the patients without the keratogrow treatment (control). The x-axis of the graph represented untreated volunteers and y-axis of the graph represented density of the hair fiber counts per cm2.
Fig. 3 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 for the patients treated with the keratogrow treatment. The period of observation used for the measurement was 0 month, 3 months and 6 months.
Fig. 4 illustrates a graphical representation of measurement of density of the hair fiber counts for the patients treated with the keratogrow treatment. The x-axis of the graph represented treated volunteers and y-axis of the graph represented density of the hair fiber counts per cm2.
Fig. 5 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 in patients treated with and without the keratogrow treatment. The period of observation used for the measurement was 0 month, 3 months and 6 months.
Fig. 6 illustrates a graphical representation of a measurement of density of the hair fiber counts per cm2 in patients treated with and without the keratogrow treatment. The x-axis of the graph represented period of observation and y-axis of the graph represented density of the hair fiber counts per cm2. The period of observation was taken in an interval of 0 months, 3 months and 6months. The results of the experiment showed higher density of the hair fiber counts per cm2 in patients treated with the keratogrow treatment in comparison to patients treated without the keratogrow treatment.
Example 2
An experiment was conducted as (Phase-I trial) to measure the rate of hair loss in the one or more androgenetic alopecia patients with and without the keratogrow treatment. The term control generally refers to measuring the rate of hair loss in the androgenetic alopecia patient without the keratogrow treatment.
Fig. 7 illustrates a tabular representation of measurement of rate of hair loss per day during 0 month, 3 months and 6 months for the patients without the keratogrow treatment (control).
Fig. 8 illustrates a graphical representation measurement of rate of hair loss for the patients without the keratogrow treatment (control). The x-axis of the graph represented untreated volunteers and y-axis of the graph represented rate of hair loss per day for 6 months.
Fig. 9 illustrates a tabular representation of measurement of rate of hair loss per day during 0 month, 3 months and 6 months for the patients with the keratogrow treatment (control).
Fig. 10 illustrates a graphical representation of measurement of rate of hair loss for the patients treated with the keratogrow treatment. The x-axis of the graph represented treated volunteers and y-axis of the graph represented rate of hair loss per day for 6 months.
Fig. 11 illustrates a tabular representation of measurement of rate of hair loss with and without the keratogrow treatment. The period of observation for the measurement was 0 month, 3 months and 6 months.
Fig. 12 illustrates a graphical representation of measurement of rate of hair loss before and after the keratogrow treatment. The x-axis of the graph represented period of observation and y-axis of the graph represented rate of hair loss per day for 6 months. The period of observation was taken in an interval of 0 month, 3 months and 6months. The results of the experiment showed lesser rate of hair loss per day for 6 months in patients treated with the keratogrow treatment in comparison to patients treated without the keratogrow treatment.

Example 3
An experiment was conducted as (Phase-II trial) to measure the density of the hair fiber counts in the one or more androgenetic alopecia patients with and without the keratogrow treatment. The control generally refers to measuring the hair fiber count in the androgenetic alopecia without the keratogrow treatment. The Follicular density at a calibrated distance from the mid-pupillary point in a 1cm x 1cm square was measured using digital photographs taken at 0 month, 3 months, and 6 months follow up visits after the keratogrow treatment. Hair density indices were compared using the trichoscope with photographs from similar area on different subjects without the keratogrow treatment.
Fig. 13 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 for the patients without the keratogrow treatment (control). The period of observation used for the measurement was 0 month, 3 months and 6 months.
Fig. 14 illustrates a graphical representation of measurement of density of the hair fiber counts for the patients without the keratogrow treatment (control). The x-axis of the graph represented untreated volunteers and y-axis of the graph represented density of the hair fiber counts per cm2.
Fig. 15 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 for the patients treated with the keratogrow treatment. The period of observation used for the measurement was 0 month, 3 months and 6 months.
Fig. 16 illustrates a graphical representation of measurement of density of hair fiber counts for the patients treated with the keratogrow treatment. The x-axis of the graph represented treated volunteers and y-axis of the graph represented density of the hair fiber counts per cm2.
Fig. 17 illustrates a tabular representation of measurement of density of the hair fiber counts per cm2 in patients treated with and without the keratogrow treatment. The period of observation used for the measurement was 0 month, 3 months and 6 months.
Fig. 18 illustrates a graphical representation of final data of measurement of density of hair fiber counts before and after the keratogrow treatment. The x-axis of the graph represented period of observation and y-axis of the graph represented density of the hair fiber counts per cm2. The period of observation was taken in an interval of 0 month, 3 months and 6 months. The results of the experiment showed higher density of the hair fiber counts per cm2 in patients treated with the keratogrow treatment in comparison to patients treated without the keratogrow treatment.
Example 4
An experiment was conducted as (Phase-II trial) to measure the rate of hair loss in the one or more androgenetic alopecia patients with and without the keratogrow treatment. The term control generally refers to measuring the rate of hair loss in the androgenetic alopecia patient without the keratogrow treatment.
Fig. 19 illustrates a tabular representation of measurement of rate of hair loss per day during 0 month, 3 months and 6 months for the patients without the keratogrow treatment (control).
Fig. 20 illustrates a graphical representation measurement of rate of hair loss for the patients without the keratogrow treatment (control). The x-axis of the graph represented untreated volunteers and y-axis of the graph represented rate of hair loss per day for 6 months.
Fig. 21 illustrates a tabular representation of measurement of rate of hair loss per day during 0 month, 3 months and 6 months for the patients with the keratogrow treatment (control).
Fig. 22 illustrates a graphical representation of measurement of rate of hair loss for the patients treated with the keratogrow treatment. The x-axis of the graph represented treated volunteers and y-axis of the graph represented rate of hair loss per day for 6 months.
Fig. 23 illustrates a tabular representation of measurement of rate of hair loss per day during 0 month, 3 months and 6 months for the patients treated with and without the keratogrow treatment. The period of observation for the measurement was 0 month, 3 months and 6 months.
Fig. 24 illustrates a graphical representation of measurement of rate of hair loss before and after the keratogrow treatment. The x-axis of the graph represented period of observation and y-axis of the graph represented rate of hair loss per day for 6 months. The period of observation was taken in an interval of 0 month, 3 months and 6 months. The results of the experiment showed lesser rate of hair loss per day for 6 months in patients treated with the keratogrow treatment in comparison to patients treated without the keratogrow treatment.
The described embodiments are to be considered in all respects only as illustrative, and not restrictive, and the scope of the present invention is, therefore, indicated by the appended claims rather than by the foregoing description or drawings. Consequently, while the present invention has been described with reference to particular embodiments, modifications of structure, sequence, materials and the like apparent to those skilled in the art still fall within the scope of the invention as claimed by the applicant.
,CLAIMS:I/We Claim:
1 A keratogrow formulation for reduction of hair loss and stimulating hair growth, the keratogrow formulation comprising;
an at least one polyethylene glycol (PEG), the polyethylene glycol (PEG) concentration is in a range of 2mM to 12mM;
an at least one benzalkonium chloride (BKC), the benzalkonium chloride (BKC) concentration is in a range of 0.5%to 5.0%;
an at least one amoxicillin, the amoxicillin concentration is in a range of 100mg to 1000mg;
an at least one placentrix, the placentrix concentration is in a range of 0.1% to 15%; and
an at least one adenosine triphosphate (ATP), the adenosine triphosphate (ATP) concentration is in a range of 0.5mM to 5mM.
2. The keratogrow formulation as claimed in claim 1, wherein the at least one polyethylene glycol (PEG) concentration is 8mM.
3. The keratogrow formulation as claimed in claim 1, wherein the at least one benzalkonium chloride (BKC) concentration is 1.5%.
4. The keratogrow formulation as claimed in claim 1, wherein the at least one amoxicillin concentration is 500mg.
5. The keratogrow formulation as claimed in claim 1, wherein the at least one placentrix is 4%.
6. The keratogrow formulation as claimed in claim 1, wherein the at least one adenosine triphosphate (ATP) concentration is 2mM.
7. A keratogrow formulation for reduction of hair loss and stimulating hair growth, the keratogrow formulation comprising:
an at least one keratogrow formulation having:
an at least one polyethylene glycol (PEG), the at least one polyethylene glycol (PEG) concentration is 8mM;
an at least one benzalkonium chloride (BKC), the at least one benzalkonium chloride (BKC) concentration is 1.5%.
an at least one amoxicillin, the at least one amoxicillin concentration is 500mg;
an at least one placentrix, the at least one placentrix have the concentration is 4%.; and
an at least one adenosine triphosphate (ATP), the at least one adenosine triphosphate (ATP) concentration is 2mM.
8. A method for autologous kertaogrow production, the method comprising:
an at least one peripherial blood sample, the at least one peripheral blood sample is selected in a range between 1 ml to 40 ml;
an at least one polyethylene glycol (PEG), the at least one polyethylene glycol (PEG) is selected in a concentration range of 2mM to 12mM;
an at least one benzalkonium chloride (BKC), the at least one benzalkonium chloride (BKC) is selected in a concentration range of 0.5%to 5.0%;
an at least one amoxicillin trihydrate, the at least one amoxicillin trihydrate is selected in a concentration range of 100mg to 1000mg;
an at least one normal saline, the at least one normal saline is selected in a volume range of 1 ml to 100 ml; and
an at least one adenosine triphosphate (ATP), the at least one adenosine triphosphate (ATP) is selected in a concentration range of 0.5mM to 5mM,
wherein the autologous keratogrow production method is carried out under laminar air flow in, the inner surface of a biosafety hood, the at least one peripheral blood (PB) sample is transferred to atleast one centrifuge tube, the at least platelet rich plasma (PRP) layer is transferred in to at least one falcon tube, the at least one platelet rich plasma (PRP) layer is further heated using at least one water bath and passed through at least one cell strainer to remove precipitates after the centrifugation, at least one or more supernatants transferred into the at least one falcon tube comprises a mixture of the at least one normal saline, the at least one adenosine triphosphate (ATP), the at least one polyethylene glycol (PEG), and the at least one benzalkonium chloride (BKC) and the at least one amoxicillin trihydrate, the mixture is autoclaved and passed through a grade 1 whatman filter paper after cooling and the mixture is finally transferred into at least one bottle.