Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1993-06-07
1995-07-11
Robinson, Douglas W.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
514925, 514928, 536 187, A61K 31725
Patent
active
054321670
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a cell proliferation matrix which consists of an aqueous gel of hyaluronic acid or a pharmaceutically acceptable salt thereof, which is in a dissolved state. It also relates to the use of hyaluronic acid or a pharmaceutically acceptable salt thereof for the preparation of a cell proliferation matrix. Further, it relates to a method of treating at least one of bone fractures, Ulcus Varicosum Cruris, and ulcera caused by Diabetes Mellitus and other diseases with impaired arterial blood flow, wherein the cell proliferation matrix according to the invention is used.
BACKGROUND
Ulcus Varicosum Cruris and ulcera caused by Diabetes Mellitus and other diseases with impaired arterial blood flow, such as Decubitus, are ulcera which are very slow-healing due to defective nutrition of the cells. Such ulcera may not heal in years, and the patients often repeatedly suffer from infections. These are normally treated with antibiotics, but such treatment is not always successful.
Obviously there is a great need of medical aid for the treatment of such slow-healing ulcera.
In EP-312208-A there is disclosed a gel for topical and incisional wound healing comprising a polypeptide growth factor (PGF) having human mitogenic or angiogenic activity and a water soluble or swellable polymer, which i.a. may be hyaluronic acid. The gel is to be applied to gauze to form a wound healing bandage which stimulates cell growth and increases the rate of healing.
DESCRIPTION OF THE INVENTION
It was surprisingly found that an aqueous gel of hyaluronic acid or a pharmaceutically acceptable salt thereof, in a dissolved state, alone functions as a cell proliferation matrix. Since the cell proliferation matrix according to the invention does not only promote epithelial but also endothelial cell growth, it is expected that it will promote osteoblast growth as well. Thus it can be used in the treatment of bone fractures, Ulcus Varicosum Cruris and ulcera caused by Diabetes Mellitus and other diseases with impaired arterial blood flow, such as Decubitus.
Hyaluronic acid is widely distributed in connective tissues in mammals, but only in small quantities, and it is also known to be present in microorganisms. Hitherto hyaluronic acid has mostly been extracted from rooster combs, bovine joints and whale cartilages. However, it forms in the animal tissues complexes with proteins and other mucopolysaccharides, and therefore it is complicated to purify, and thus there is always a risk of contamination by animal DNA and RNA, which may carry DNA and RNA viruses, such as hepatite B virus and HIV virus. Therefore the hyaluronic acid or pharmaceutically acceptable salt thereof which is to be used in the present invention should be free from animal DNA and RNA. Such hyaluronic acid can be produced by microorganisms, and one disclosure of the production of such hyaluronic acid has been published in EP-A-0 266 578. The sodium hyaluronate used in the clinical trials below has been produced by continuous fermentation of Streptococcus equi by FERMENTECH Ltd., Research Avenue South, Riccarton Campus, Edinburgh EH14 4AP, Scotland.
In a preferred embodiment of the cell proliferation matrix according to the invention the aqueous gel is made of 99.9 to 98.0 percent by weight of water or of phosphate buffered saline solution and 0.1 to 2.0 percent by weight of sodium hyaluronate having an average molecular weight of at least 25,000 Da. It is believed that the average molecular weight of sodium hyaluronate is not critical as long as it is at least 25,000 Da and as long as it is in a dissolved state. The average molecular weight of the sodium hyaluronate to be used in the invention is suitably in the range of 1.2.times.10.sup.6 -2.5.times.10.sup.6 Da. In a preferred embodiment of the invention the cell proliferation matrix consists of an aqueous gel containing 1.0 percent by weight of sodium hyaluronate having an average molecular weight of 1.2.times.10.sup.6 Da.
It should be understood that the aqueous gel according to the invention sh
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Fonda Kathleen Kahler
Robinson Douglas W.
Skandigen AB
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