Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2001-02-22
2003-04-29
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S725000, C424S773000, C424S774000, C424S779000, C424S093700, C424S767000, C424S078060, C424SDIG001, C514S783000, C514S844000, C514S944000, C514S945000
Reexamination Certificate
active
06555118
ABSTRACT:
DETAILED DESCRIPTION
Wound healing involves a complex but orderly sequence of cellular events that culminates in the restoration of structural integrity of tissue. The orderly influx of inflammatory cells, proliferation of stromal elements, in-growth of blood vessels, and production of an extra-cellular matrix are essential for rapid and efficient healing. Maximum tissue strength is achieved through the regulated remodeling and maturation of the extra-cellular matrix. Tissue repair is regulated in part by cells at the wound site that control the local production of growth factors, including transforming growth factor beta. Wound healing begins with a repair cascade, which culminates in the formation of new granulation tissue.
Cutaneous ulcers are a common, chronic problem and are primarily developed as pressure (decubital) sores. In addition to causing pain and discomfort and predisposing the patient to superficial and chronic infection, significant costs are associated with the treatment that is often long-term. Chronic ulcers may also arise as a result of chronic steroid therapy for autoimmune disease or atopic dermatitis as well as chemotherapy for cancer. These conditions and their treatment regimens may impair the normal wound healing process and often result in chronic ulcers. While the etiology of pressure sores or ulcers resulting from chronic steroid or chemotherapy may be different, the underlying manifestation is the lack of formation of granulation tissue and re-epithelialization of the defect. Depending on the health and background of the patient, these cutaneous open wounds and ulcers can persist chronically for extended periods of time. Each of these types of cutaneous open wounds and ulcers results in considerable discomfort to the patient and presents a continuing opportunity for even more serious infections or complications to occur. In addition to these common cutaneous open wounds and ulcers, a variety of other skin defects are known to occur in both animals and humans, including lacerations, perforations, wounds which are traumatic in origin, venous stasis ulcers, and other types of lesions.
These types of wounds also occur in other vertebrates such as birds and reptiles. The fundamental pathogenesis of wounds and processes for wound healing is similar for all vertebrates, and therefore the person of ordinary skill will realize that the methods and compositions of the present invention are useful for treating chronic wounds and ulcers in all vertebrates.
By “open wound” is meant any injury, which communicates with the atmosphere, by direct exposure. Open wounds include, but are not limited to, decubital ulcers, dehiscence wounds, acral lick dermatitis (acral lick granulomas in animals), lacerations, and wounds that are traumatic in origin. By “ulcer” is meant a break in the continuity of the epidermis with a loss of substance and exposure of underlying tissue. By “chronic cutaneous open wound or ulcer” is meant a cutaneous open wound or ulcer, which has shown resistance to completing the healing process. By “burn wounds” is meant a surface wound ranging from first to third degree burn and ranging from affecting 1% to 99% body surface area.
The cessation of blood flow to an ischemic lesion can be developed in a slow and gradual form such as in the case of decubitus ulcers and stasis ulcers, or may take place more acutely such as in thermo-radiation and chemical burns. In the absence of nutrition, the rate of fluid delivery of nutrients decreases bringing a progressive impairment in the viability of cells and tissues. This eventually leads to degeneration and death of the tissue and cells in a condition known as necrosis. Necrosis is generally accompanied by bacterial, fungal and/or viral contamination. As further pointed out in the aforementioned patent, treatment of exudative skin wounds with a starch hydrolysate dressing produces a greatly reduced bacteria count of an infected wound and inhibits infection of an uninfected wound. In addition, application of the starch hydrolysate to a wound or ulcer produces a film or semi-permeable membrane which allows edematous liquid to pass through while proteinaceous material is retained within the body, allowing reduction in the volume of exudate in relatively clean condition.
The process of wound healing consists of three phases during which the injured tissue is repaired, regenerated, and new tissue is reorganized into a scar. These three phases are classified as: a) an inflammation phase which begins from day 0 to 3 days, b) a cellular proliferation phase from 3 to 12 days, and c) a remodeling phase from 3 days to about 6 months. In the inflammation phase, inflammatory cells, mostly neutrophils, enter the site of the wound followed by lymphocytes, monocytes, and later macrophages. The neutrophils that are stimulated begin to release proteases and reactive oxygen species into the surrounding medium with potential adverse effects on both the adjacent tissues and the invading microorganisms. The oxygen species known to be released by the neutrophils are superoxide through the action of a plasma membrane-bound NADPH oxidase, hydrogen peroxide formed by action of dismutation of superoxide, and HOCl produced by the action of myeloperoxidase with hydrogen peroxide. The proliferative phase consists of laying down new granulation tissue, and the formation of new blood vessels in the injured area. The fibroblasts, endothelial cells, and epithelial cells migrate in the wound site. These fibroblasts produce the collagen that is necessary for wound repair. In reepithelialization, epithelial cells migrate from the free edges of the tissue across the wound. This event is succeeded by the proliferation of epithelial cells at the periphery of the wound. Research has also shown that reepithelialization is enhanced by the presence of occlusive wound dressings which maintain a moisture barrier. The final phase of wound healing, which is remodeling, is affected by both the replacement of granulation tissue with collagen and elastin fibers and the devascularization of the granulation tissue.
A large variety of treatment and modalities are available for the treatment of wounds and ulcers as described here. These range from applications of antibiotics, occlusive layers, bandages, poultices, mechanical devices that reduce evaporation of water and many others. However, all of these modalities have one drawback in common; they all enhance wound healing by supporting the body mechanisms to heal the wound. Unfortunately, the passive healing process results in much disappointment because the body may have compromised immunity or other body functions that may not work optimally. What is needed is a modality of treatment that will actively regenerate the skin, dermis and epidermis. In the invention described here, the specific composition actively promotes healing by stimulating stem cells that are present even in deep wounds and burns to regenerate the lost tissue.
Stem cells are by definition present in all self-renewing tissues. These cells are believed to be long-lived, have a great potential for cell division and are ultimately responsible for the homeostasis of steady-state tissues. Stem cells are normally slow cycling. They can, however, be induced to enter the proliferative pool in response to certain growth stimuli. When stem cells undergo occasional cell division, they give rise to more rapidly proliferating “transient amplifying cells” (“TA”). Stem cells possess many of the following properties: they are relatively undifferentiated, ultrastructurally and biochemically; they have a large proliferative potential and are responsible for the long term maintenance and regeneration of the tissue; they are normally “slow-cycling”, presumably to conserve their proliferative potential and to minimize DNA errors that could occur during replication; they can be stimulated to proliferate in response to wounding and to certain growth stimuli; they are often located in close proximity to a population of rapidly proliferating cells corresponding t
Krass Frederick
Ostrup Clinton
Welsh & Katz Ltd.
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