WO2007084127A1 - Utilisation de gluten en tant qu'agent cicatrisant pour le traitement de plaies - Google Patents

Utilisation de gluten en tant qu'agent cicatrisant pour le traitement de plaies Download PDF

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Publication number
WO2007084127A1
WO2007084127A1 PCT/US2006/001889 US2006001889W WO2007084127A1 WO 2007084127 A1 WO2007084127 A1 WO 2007084127A1 US 2006001889 W US2006001889 W US 2006001889W WO 2007084127 A1 WO2007084127 A1 WO 2007084127A1
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WO
WIPO (PCT)
Prior art keywords
gluten
wound
treatment
cream
ointment
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Application number
PCT/US2006/001889
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English (en)
Inventor
Verdon Peters
Larry Oliver
Michael Anderson
Original Assignee
Verdon Peters
Larry Oliver
Michael Anderson
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Verdon Peters, Larry Oliver, Michael Anderson filed Critical Verdon Peters
Priority to PCT/US2006/001889 priority Critical patent/WO2007084127A1/fr
Publication of WO2007084127A1 publication Critical patent/WO2007084127A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials

Definitions

  • a method for wound treatment employing gluten as the active healing ingredient, especially for chronic wounds.
  • a wound is a disruption of tissue integrity often associated with trauma. Deep injuries into the muscle tissue, the skeletal system, or the inner organs are defined as complicated wounds and usually require emergency medical treatment. Chronic wounds are classified as chronic when they heal very slowly or fail to heal at all. Generally, wounds that do not heal in a timely fashion (generally 6 to 8 weeks) are classified as chronic wounds.
  • Chronic wounds often result from other serious health problems such as diabetes, heart disease and circulation disorders. Other contributing factors include poor nutrition and abnormal sustained pressure on skin over bony areas.
  • the most common types of chronic wounds are leg ulcers and diabetic foot ulcers.
  • An ulcer is an open sore, usually associated with circulatory problems.
  • diabetes poor blood flow and high blood sugar levels can damage nerves in the foot causing a person not to feel pain as well as inhibit healing in general.
  • a cut that goes unnoticed can then go on to develop into a foot ulcer.
  • Diabetic ulcers usually occur on the foot or leg as a result of poor arterial circulation and nerve damage.
  • Venous stasis ulcers are the most common type of leg ulcer and results from poor venous blood circulation.
  • Pressure ulcers are another type of chronic wound and are usually caused by unrelieved pressure. Patients who are elderly, malnourished, bedridden or paralyzed are more prone to this type of wound because they spend long periods of time in contact with a surface without relief of the pressure. Arterial ulcers usually result from "poor circulation” or “hardening of the arteries,” and typically occur on the toes or feet. These types of chronic wounds typically need special treatment to prevent more serious health problems.
  • wound healing Every wound to the human body initiates the body's healing mechanisms that are designed to restore tissue integrity through formation of new structures that more or less match the original. While wound healing is often viewed as a locally regenerative process, it should be more properly viewed as determined by the overall health of the afflicted person. On this level, wound healing depends on diverse factors such as age, nutrition, medication, immunologic status, metabolic condition, and circulatory status. Compromised circulation is perhaps the greatest single contributory factor for people with chronic wounds that are slow healing or that refuse to heal.
  • Wound healing proceeds in three interrelated dynamic phases regardless of the wound type and the degree of tissue damage. These phases are clinically distinguished as an inflammatory or exudative phase for the detachment of deteriorated tissue and for wound cleansing, a proliferative phase for the development of granulation tissue and a differentiation or regeneration phase for maturation, scar formation and epithelialisation.
  • the three phases can be designated as cleansing phase, granulation phase, and epithelialisation phase.
  • the invention provides a wound care product that can be used on all types of human or animal ulcers of the skin.
  • Plant protein hydrolysates preferably selected from the group consisting of corn gluten hydrolysate, wheat gluten hydrolysate, soy protein hydrolysate, and mixtures thereof, have been found to actively promote healing in patients with chronic wounds.
  • Corn gluten hydrolysate, in the form of dry corn gluten, prepared as disclosed herein has been observed to heal ulcers in six to eight weeks.
  • the invention uses gluten as a unique active ingredient primarily for treating chronic wounds (e.g. ulcers).
  • the invention uses a topical application comprised of between 100% and 2.5% gluten.
  • Gluten can be applied to the wound either as a pure micro powder paste of about 1 and 5 microns in diameter or is combined with a base topical cream or ointment.
  • LipodermTM, pluronic F 127, XenadermTM, AquaphorTM, patrolaneum, and an emollient cream were all used in treatment testing.
  • Preferred treatments include ground 100% gluten powder paste (e.g. 80%- 90% gluten after processing commercially available gluten) for direct application on a wound, a topical ointment of 2.5 g per 100 g (e.g.
  • a topical treatment ointment of 2.5% gluten by weight for application to a wound and a developed emollient cream made from polyoxyl 40 stearate, propylene glycol, cetyl alcohol, stearly alcohol, isopropyl myristate, sodium benzoate, and comprised of 2.5% gluten by weight.
  • Other topical creams or ointments may be used containing gluten added as the active ingredient to comprise between 2.5% and 75% by weight.
  • Fig. 1 is a process chart summarizing the invention.
  • the invention utilizes a plant protein hydrolysate, corn gluten, as the active ingredient for various wound care options.
  • Gluten is an amorphous ergastic protein found combined with starch in the endosperm of some cereals, notably wheat, rye, and barley. It is also found in corn, soybeans, rice and legumes, and it constitutes about 80% of the proteins contained in wheat. It is composed of the proteins gliadin and glutenin.
  • Gluten is generally used in the food industry and is responsible for the elasticity of kneaded dough, which allows it to be leavened, as well as the "chewiness" of baked products like bagels. It has been associated with damage to the intestine in some people possibly leading to ulcers, but it has not been traditionally been associated with topical medical treatment options.
  • corn starch has been known to yield positive results for babies and elderly patient for several years.
  • Corn gluten meal is commercially available as a byproduct of corn milling. It is made by drying the liquid gluten stream separated from corn during corn wet milling processing. In the wet milling process of corn, the following fractions are obtained: corn starch, corn oil, defatted corn germ, corn hulls, corn steep liquor, and corn gluten (the protein fraction). Corn gluten is typically separated from the starch stream by centrifugation to yield a thick, yellow slurry of corn gluten containing 15% to 20% solids. Conventionally, the corn gluten is filtered and dried to produce solid corn gluten meal, which is generally sold as an animal feed product. This is the source of the gluten experimentally used leading to the claimed invention.
  • Granulated 60% corn gluten meal was used manufactured by Grain Processing Corporation (GPC). Table 1 provides GPCs manufacturing specification for the product.
  • the present plant protein hydrolysates are preferably prepared by a process comprising treating an aqueous slurry of a plant protein such as corn or wheat gluten or soy protein with acid or with one or more enzymes.
  • the base material was the 60% corn gluten meal.
  • the plant protein is treated with one or more proteases, and most preferably, is pre-treated with one or more amylases.
  • the proteinaceous slurry may be treated with amylases, followed by filtration to remove the solubilized carbohydrates. The insoluble residue is then treated with one or more proteases to solubilize the protein components. After pH adjustment with acid, the slurry is filtered and/or centrifuged.
  • the effluent is dried in a conventional manner to yield "corn gluten hydrolysate", “wheat gluten hydrolysate”, or “soy protein hydrolysate”, which is essentially water soluble (>90% at 10 g/100ml).
  • the protein slurry can be treated with proteases alone and the entire reaction mixture dried, or the reaction mixture may be centrifuged or filtered and the supernatant or filtrate dried in an appropriate manner, to yield a soluble plant protein hydrolysate.
  • the liquid corn gluten (15%-20% solids) is preferably diluted with water to a solids concentration in the range of approximately 5% to 20% and the pH adjusted to about 6.0 to 8.0, preferably to about pH 6.5.
  • the appropriate amylase is added (0.1 to 1.0% dry basis (DB)) and the slurry jet cooked at 280° to 340° F, preferably at 320° F for 3-4 minutes.
  • the cooked slurry is then adjusted to about pH 4.0 to 0.5, cooled to 140° F, and optimally, a saccharifying amylases (glucoamylase) is added (.01% to 0.1% DB) and the slurry maintained at 140 0 F for 8-16 hours, preferably 12 hours.
  • DB dry basis
  • the slurry is then filtered and washed and the filtrate and washings discarded.
  • the filter cake is reslurried in water to 5% to 20% solids (preferably approximately 10%) and adjusted to pH 7.5 to 9.0 with Ca(OH) 2 ..
  • An alkaline protease is then added (0.1% to 1.0% DB) and the slurry is maintained at 50° to 60°C for 2 to 6 hours, or until the pH remains constant.
  • the slurry is then adjusted to pH 6.0 to 6.8 (preferably pH 6.2), and the precipitated Ca 3 (PO 4 ) 2 and insoluble residue is removed by filtration.
  • the clear filtrate is then dried in an appropriate manner (i.e.
  • the corn gluten hydrolysate will have a nitrogen content of at least about 8%, in the range of 8%-16%, and most preferably at about 14.4%.
  • the gluten was finely reduced to a ground powder form of approximately 1 to 5 microns in diameter.
  • GLUTEN #1 Pure plant form that is a filtered base and then freeze-dried.
  • GLUTEN #2 Comprised of soluble and insoluble filtrates approximately 69% protein.
  • GLUTEN #4 The most water soluble and pure form is greater than 90% at 10g/100ml.
  • the gluten was applied to wounds as a topical active treatment using several different techniques. This included direct application of the prepared gluten to the wound and mixing with several different therapeutic base preparations that included LipodermTM, emollient cream, vanishing cream, petrolatum, pluronic lecithin organasol, Aquaphor. The case studies using this treatment options have demonstrated that the gluten protein possesses a bacteriostatic and bacteriological effect as well as acting as a healing stimulant on open ulcers and other wounds.
  • the active component is the protein component of the corn gluten meal, but it is believed that any source of gluten prepared as above will provide the same treatment effectiveness.
  • the composition of the unprocessed gluten is 15% gluten protein, 70% starch, and the remaining 15% salts, polypeptides, and various amino acids.
  • the gluten composition comprised at least 70% protein and generally should consist of 80% to 90% gluten protein with the remaining additional 10% to 30% comprising varying amounts of amino acids, salts, polypeptides, and starch.
  • the ratio for medical application is 0.2cc of gluten to 1.0 cm of wound surface. This can be applied twice daily or as directed by the treating physician. Treatment application varies and is not to exceed two to three days without reapplication. The most active form of gluten observed was gluten #2 in a LipodermTM transdermal base.
  • Typical bases include LipodermTM, emollient cream, vanishing cream, petrolatum, pluronic lecithin organasol (e.g. pluronic F 127), XenadermTM, and AquaphorTM. LipodermTM was used as the base ointment that demonstrated the best results.
  • LipodermTM is a brand item comprised of a liposomal component that provides a high chemical penetration enhancer value, allowing medication to reach the circulatory system and local tissue quickly.
  • XenadermTM is a brand item comprised of Trypsin 90 units, Balsam Peru 87mg, Castor Oil 788 mg, and inactive ingredients Safflower Oil, and aluminum magnesium hydroxide stearate. It is an effective capillary bed stimulant that increases circulation in the wound site area.
  • Pluronic F 127 is a polaxamer emulsifier with soap-like characteristics that performs as a carrier of water-soluble drugs for percutaneous absorption of active medical ingredients. It is odorless, colorless, and non-greasy.
  • AquaphorTM is a petrolatum base that is widely used as a dermatological base. It is a neutral anhydrous base for compounding stable emulsifers, highly miscible with both aqueous solutions and oil based substances.
  • Petrolatum is a colorless to yellowish white hydrocarbon mixture obtained by fractional distillation of petroleum. It is used in preparations of medicinal ointments and lubrication. AU of these inactive base ointments are a smooth cream with a good slip upon skin application having solubilizing and penetration enhancement properties. They are essentially colorless, odorless, and exhibit good spreading capabilities.
  • Adjunctive therapies used along with the gluten treatment included Metronidazole, Gentamycin, Mupricion, Papain Urea, Silver Sulfur compounds, Clotrimazole, Copper complex sodium, Diflucan, Nystatin, Triamcinolone, Nifedipine, and Pentoxifylline.
  • the first case study involved a patient with an ulcer on left ankle and foot of approximately two years duration and with a history of extremely poor hygiene and unhealthy living conditions.
  • the patient was first examined on November 15, 2002 suffering from an ulcer. Over the course of the next two years, the patient received standard chronic wound care treatment that included cleaning of the effected area, spraying with .25% acetic acid, applying various dressings, debriding necrotic tissue, rinsing with .09% sterile normal saline, treating with antifungal cream, and treating with antibiotics between November 15, 2002 and March 30, 2004.
  • the treatment regimen was switched to Gluten #1 on August 23, 2004 by treating the upper half of wound with that gluten preparation and treating the lower half with flagyl-triple (50/50) along with conventional debridement.
  • the size of the wound was observed to be 30rnmx30mm with continued positive response, and the treatment was switched to 100% gluten powder on the wound.
  • the wound size was recorded as 23mmx30mm with granulation still improving.
  • the wound showed rapid improvement in response to the gluten powder applied directly to the wound, and by September 9, 2004 the wound had shrunk to 20mmx30mm with very good granulation. Rapid healing was noted from September 2, 2004 to September 23, 2004 with wound size reduced to 13mmxl8mm by September 23, 2004. By October 7, 2004, the wound size was 10mmxl4mm, and on October 8, 2004 it was noted that epithelization of the edge of the wound had increased. Between October 15 and October 22, 2004, the wound closure had improved by 50%. The patient progressed slowly but with positive progress with the wound, and on October 29, 2004 hyperbaric treatment was discontinued after sixty treatments. Patient was placed on conventional wound care using gluten alone. The ulcer showed complete closure on December 27, 2004 when the patient was discharged. CASE STUDY #5
  • the patient first presented on May 6, 2004 suffering from an ulcer on the ankle.
  • the ulcer slowly improved with conventional treatment options utilized.
  • the first treatment of gluten was applied on May 26, 2004, and by June 2, 2004 the ulcer measured 20mmx20mmx3mm in size with positive healing progress.
  • granulation was noted with slow improvement of the ulcer and further treatment using gluten.
  • the ulcer measured 20mmx25mmx.5mm in size, and the ulcer was treated with conventional rinsing and cleaning along with gluten.
  • the gluten used in the case studies was granulated 60% corn gluten meal manufactured by Grain Processing Corporation (GPC) and processed as stated above.
  • Corn gluten is a commercially available material extracted from meal by drying the liquid gluten stream separated from corn during wet milling processing. While the specific composition can vary, generally commercially available gluten consists of about 60% protein with the remainder made up lipid, carbohydrate, and ash material.
  • the following table sets forth the typical protein composition of corn gluten in this commercial form:
  • the processed gluten product used in the testing consisted of micro powdered gluten milled to a size of between 1 to 5 microns in diameter.
  • the processed gluten was comprised of at least 70% gluten protein, generally in the range of 80% to 90% protein and containing about 12% nitrogen.
  • the gluten was then mixed with glycerin to form a paste and generally added to a base topical preparation in the form of a cream or ointment.
  • the pure gluten protein paste was also used in testing.
  • the following tables set forth additional information on the gluten formulations.
  • Step 1 At a temperature of 80°-85°C, mix all the ingredients of Step 1 through 3. Remove from heat and continue mixing until temperature drops to 45°C.
  • Treatment with 2.5% gluten powder in LipodermTM base demonstrated the best observed healing response. Rapid granulation and healing began within one week of the first application and provided positive visual results upon the next visit after the first application.
  • An active base amount of gluten less than 1.0% demonstrated little or no improvement to a wound after treatment and was not regarded as an effective treatment amount.
  • Gluten as a percent of total amount of application that obtained noticeable and desired healing results ranged from greater than 1% to 100%.
  • These best results were also obtained from an application of a gluten topical treatment of at least 2.5% applied twice daily in an amount sufficient to cover the entire wound.
  • Optimal results were obtained for a topical treatment concentration equaling .2cc processed gluten protein per 1.0 cm 2 wound surface area applied twice daily and not exceeding two to three days without reapplication. It is important that continued application under this protocol occur until a scab forms over the wound, indicating continued healing with adequate circulation and clearing of active bacterial infection.
  • the gluten can be used alone or as a component of a treatment cream or ointment, with a composition of 1% to 100% by weight, preferably in the range of 2.5% to 75% as an ingredient to a cream or ointment base.
  • a composition of 1% to 100% by weight preferably in the range of 2.5% to 75% as an ingredient to a cream or ointment base.
  • LipodermTM is preferred, any base topical ointment is acceptable.
  • Topical ointment bases used in the case studies showing acceptable wound healing included XenadermTM, petrolatum, Pluronic F 127, AquaphorTM, and the emollient cream described above, but it is believed that any topical base with similar characteristics provides acceptable results as long as a gluten micro powder of at least 70% gluten protein in the size of 1 to 5 microns is present to form a >2.5% gluten treatment composition ointment.
  • the preferred treatment procedure is to apply the gluten treatment composition to the wound at least twice daily along with other conventional treatment protocols as required. For example, debridement of necrotic tissue, once or twice a week, should be continued, with care exercised not to remove granulation tissue. Rinsing and cleaning of the wound as required should also be performed. Patients should also use prescribed protective covers, but the gluten application does not require that any protective covering be used such as a dressing.
  • the prescribed protective covering is primarily needed to prevent the topical gluten treatment from being wiped away from the wound and to protect the wound from painful contact with clothing while it heals.
  • the application protocol of at least .2cc gluten per 1.0 cm wound area applied at least twice daily is the preferred treatment protocol.
  • FIG. 1 is a process flow chart summarizing the invention.
  • gluten protein is obtained from a plant source, such as corn, wheat, rye, barley, soybeans, rice, or legumes.
  • the gluten protein is processed in step 10 to obtain a gluten product comprising at least 70% gluten protein in granulated powdered form.
  • This gluten protein should also comprise at least 8%, generally between 8% and 16%, nitrogen.
  • the powdered gluten is mixed with glycerin to form a paste in step 15.
  • step 20 the gluten paste is mixed with a topical base ointment or cream or left in pure form
  • step 25 the gluten topical treatment product is milled to ensure a gluten treatment product of beween 1 and 5 microns in diameter.
  • the gluten treatment product is applied at least twice daily to a wound in sufficient quantity to equal at least .2cc of gluten protein per centimeter of wound surface area.
  • the gluten topical treatment will comrpise between 2.5% and 75% gluten protein by weight.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

L'invention concerne un protocole de traitement de plaies chroniques, telles que des ulcères, à l'aide de gluten en tant qu'agent de traitement actif. Un matériau végétal contenant une protéine du gluten est traité afin d'obtenir un composé contenant au moins 70% de protéine du gluten. Le gluten traité peut être appliqué directement sur la plaie ou combiné avec un onguent ou une crème topique de base en tant qu'agent actif. Le gluten comprend au moins 2,5% en poids de l'onguent ou de la crème topique, ou peut être appliqué directement sur la plaie sous forme pure. Le gluten est appliqué au moins deux fois par jour. Les traitements classiques de rinçage, nettoyage et débridement, suivant les besoins, sont maintenus ainsi que la surveillance subséquente du patient par un médecin au moins deux fois par semaine jusqu'à cicatrisation.
PCT/US2006/001889 2006-01-20 2006-01-20 Utilisation de gluten en tant qu'agent cicatrisant pour le traitement de plaies WO2007084127A1 (fr)

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PCT/US2006/001889 WO2007084127A1 (fr) 2006-01-20 2006-01-20 Utilisation de gluten en tant qu'agent cicatrisant pour le traitement de plaies

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2915382A1 (fr) * 2007-04-27 2008-10-31 Vincience Sa Utilisation d'un principe actif issu du mais (zea mays l) pour preparer une composition destinee a activer le cytochrome c
WO2009027823A2 (fr) * 2007-08-29 2009-03-05 Ramirez D'onofrio, Alvaro D. Composition pharmaceutique pour une stimulation sélective de procédés de cicatrisation de lésion, de procédés de tropisme tissulaire normal dermique-épidermique, sa préparation et son application
JP2013109030A (ja) * 2011-11-17 2013-06-06 Kansai Medical Univ 前立腺肥大モデルおよび前立腺手術シミュレーター

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040180026A1 (en) * 2004-03-10 2004-09-16 Tammy Ha Topical skin care composition
US20040180027A1 (en) * 2003-03-12 2004-09-16 Manoj Kumar Use of repeat sequence protein polymers in personal care compositions

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040180027A1 (en) * 2003-03-12 2004-09-16 Manoj Kumar Use of repeat sequence protein polymers in personal care compositions
US20040180026A1 (en) * 2004-03-10 2004-09-16 Tammy Ha Topical skin care composition

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2915382A1 (fr) * 2007-04-27 2008-10-31 Vincience Sa Utilisation d'un principe actif issu du mais (zea mays l) pour preparer une composition destinee a activer le cytochrome c
WO2009027823A2 (fr) * 2007-08-29 2009-03-05 Ramirez D'onofrio, Alvaro D. Composition pharmaceutique pour une stimulation sélective de procédés de cicatrisation de lésion, de procédés de tropisme tissulaire normal dermique-épidermique, sa préparation et son application
WO2009027823A3 (fr) * 2007-08-29 2009-04-23 Ramirez D Onofrio Alvaro D Composition pharmaceutique pour une stimulation sélective de procédés de cicatrisation de lésion, de procédés de tropisme tissulaire normal dermique-épidermique, sa préparation et son application
JP2013109030A (ja) * 2011-11-17 2013-06-06 Kansai Medical Univ 前立腺肥大モデルおよび前立腺手術シミュレーター

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