Physiological tissue repair and functional organ regeneration by cultivation of regenerative stem cells in vivo and in situ

• US 20060153927A1
• Filed: 12/15/2005
• Published: 07/13/2006
• Est. Priority Date: 06/28/2001
• Status: Active Grant

• Current Assignee: Rongxiang Xu
• Original Assignee: Rongxiang Xu
• Inventors: Xu, Rongxiang
• Granted Patent: US 7,972,631 B2
• Time in Patent Office: Days
• US Class Current: 424/539
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/20 having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
• CPC Class Codes: A61K 31/201 having one or two double bonds, e.g. oleic, linoleic acids
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/575 substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• CPC Class Codes: A61K 35/644 Beeswax; Propolis; Royal jelly; Honey
• CPC Class Codes: A61K 36/15 Pinaceae (Pine family), e.g. pine or cedar
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 36/286 Carthamus (distaff thistle)
• CPC Class Codes: A61K 36/48 Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
• CPC Class Codes: A61K 36/539 Scutellaria (skullcap)
• CPC Class Codes: A61K 36/61 Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
• CPC Class Codes: A61K 36/63 Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
• CPC Class Codes: A61K 36/738 Rosa (rose)
• CPC Class Codes: A61K 36/756 Phellodendron, e.g. corktree
• CPC Class Codes: A61K 36/82 Theaceae (Tea family), e.g. camellia
• CPC Class Codes: A61K 36/899 Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/14 : for baldness or alopecia
• CPC Class Codes: A61P 17/16 : Emollients or protectives, e.g. against radiation
• CPC Class Codes: A61P 19/00 : Drugs for skeletal disorders
• CPC Class Codes: A61P 25/28 : for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

The present invention provides novel compositions and methods for pharmaceutical or nutraceutical use in an animal, preferably in a human. In one aspect, compositions and methods are provided for promoting cell growth, tissue repair and organ regeneration, preferably in vivo and in situ. The composition comprises a sterol compound dissolved in oil at a concentration at least 0.5% by weight. The compositions may be used in the treatment of various conditions caused by injury, diseases and aging. As shown clinically, the methodology disclosed in the present invention was used successfully to regenerate or clone a new organ through cultivation of regenerative stem cells in vivo and in situ.

Claims

1. A composition for promoting cell growth, tissue repair and/or organ regeneration in vivo comprising:

a fatty acid-containing oil at a concentration at least 10% by weight based on the total weight of the composition; and

a sterol compound added to and dissolved in said oil at a concentration of at least 1% by weight based on the total weight of the composition.

2. The composition according to claim 1, wherein the sterol compound is esterified by the fatty acid in the oil in the composition.

3. The composition according to claim 1, wherein a fatty acid-containing oil is at a concentration at least 50% by weight based on the total weight of the composition.

4. The composition according to claim 1, wherein a fatty acid-containing oil is at a concentration at least 80% by weight based on the total weight of the composition.

5. The composition according to claim 1, wherein the concentration of the sterol compound is about 1.2-40% by weight.

6. The composition according to claim 1, wherein the concentration of the sterol compound is about 1.2-20% by weight.

7. The composition according to claim 1, wherein the concentration of the sterol compound is about 1.5-15% by weight.

8. The composition according to claim 1, wherein the concentration of the sterol compound is about 2-6% by weight.

9. The composition according to claim 1, wherein the oil is animal or vegetable oil.

10. The composition according to claim 1, wherein the oil is vegetable oil selected from the group consisting of corn oil, peanut oil, cottonseed oil, rice bran oil, safflower oil, tea tree oil, pine nut oil, macadamia nut oil, camellia seed oil, rose hip oil, sesame oil, olive oil, soybean oil and combinations thereof.

11. The composition according to claim 1, wherein the oil is a pharmaceutically acceptable oil.

12. The composition according to claim 1, wherein the oil is an injectable oil.

13. The composition according to claim 1, wherein the fatty acid is selected from the group consisting of palmitic acid, linoleic acid, oleic acid, trans-oleic acid, stearic acid, arachidic acid, and tetracosanoic acid.

14. The composition according to claim 1, wherein the sterol compound is animal sterol or phytosterol.

15. The composition according to claim 1, wherein the sterol compound is a phytosterol selected from the group consisting of stigmasterol, campesterol, β

-sitosterol, chalinosterol, clionasterol, brassicasterol, α

-spinasterol, daucosterol, desmosterol, avenasterol, cycloartenol, poriferasterol, and natural or synthesized, isomeric forms and derivatives thereof.

16. The composition according to claim 1, wherein the sterol compound is a combination of stigmasterol and β

-sitosterol.

17. The composition according to claim 1, wherein the sterol compound is a combination of brassicasterol and β

-sitosterol.

18. The composition according to claim 1, wherein the sterol compound is a combination of brassicasterol, stigmasterol and β

-sitosterol.

19. The composition according to claim 1, wherein the sterol compound is a combination of campesterol, stigmasterol and β

-sitosterol.

20. The composition according to claim 1, further comprising beeswax.

21. The composition according to claim 20, wherein the beeswax is at a concentration ranging from about 1% to 20% by weight.

22. The composition according to claim 20, wherein the beeswax in the composition forms a pigeon-hole like structure at ambient temperature or below.

23. The composition according to claim 22, wherein the dimension of at least one of the holes in the pigeon-hole like structure is below 50 micron.

24. The composition according to claim 22, wherein the dimension of at least one of the holes in the pigeon-hole like structure is below 30 micron.

25. The composition according to claim 22, wherein the dimension of at least one of the holes in the pigeon-hole like structure is below 20 micron.

26. The composition according to claim 22, wherein the dimension of at least one of the holes in the pigeon-hole like structure is between 10-50 micron.

27. The composition according to claim 1, further comprising propolis.

28. The composition according to claim 1, further comprising water at a concentration lower than 10% by weight based on the total weight of the composition.

29. The composition according to claim 1, further comprising water at a concentration lower than 1% by weight based on the total weight of the composition.

30. The composition according to claim 1, further comprising water at a concentration lower than 0.1% by weight based on the total weight of the composition.

31. The composition according to claim 1, further comprising baicalin.

32. The composition according to claim 31, wherein baicalin is at a concentration ranging from about 0.001 to 2% by weight.

33. The composition according to claim 31, wherein the composition contains an extract of huangqin in the oil, the extract containing baicalin.

34. The composition according to claim 1, further comprising an extract of huangqin in an amount of 10-90% by weight based on the total weight of the composition, wherein the amount of huangqin is 2-60% by weight based on the total weight of the oil.

35. The composition according to claim 1, further comprising obaculactone.

36. The composition according to claim 33, wherein obaculactone is at a concentration ranging from about 0.001 to 2% by weight.

37. The composition according to claim 31, wherein the composition contains an extract of huangbai in the oil, the extract containing obaculactone.

38. The composition according to claim 1, further comprising an extract of huangbai in an amount of 10-90% by weight based on the total weight of the composition, wherein the amount of huangbai is 2-60% by weight based on the total weight of the oil.

39. The composition according to claim 1, further comprising an extract of huangqin in the oil containing baicalin at a concentration ranging from about 0.001 to 2% by weight based on the total weight of the oil, wherein the sterol compound is a phytosterol and the oil is sesame oil.

40. The composition according to claim 1, further comprising an extract of heshouwu in the oil.

41. The composition according to claim 1, further comprising an extract of heshouwu in an amount of 10-90% by weight based on the total weight of the composition, wherein the amount of heshouwu is 2-60% by weight based on the total weight of the oil.

42. The composition according to claim 1, wherein the composition is substantially free of narcotoline.

43. The composition according to claim 1, wherein the composition is substantially free of papaverine.

44. The composition according to claim 43, wherein the sterol compound is a phytosterol and the oil is sesame oil.

45. The composition according to claim 1, further comprising beeswax at a concentration ranging from about 1% to 20% by weight, and an extract of huangqin in the oil containing baicalin at a concentration 0.1-2% by weight based on the total weight of the oil, wherein the sterol compound is a phytosterol at a concentration 1.5-15% based on the total weight of the oil and the oil is sesame oil.

46. The composition according to claim 1, wherein the oil is sesame oil and the sterol compound is sito-sterol isolated from a vegetable oil different than sesame oil.

47. The composition according to claim 46, wherein the vegetable oil is rice bran oil.

48. The composition according to claim 1, wherein the oil is sesame oil and the sterol compound is β

-sito-sterol isolated from a vegetable oil different than sesame oil.

49. The composition according to claim 1, wherein the composition is in a form suitable for nasal, vaginal or topical administration.

50. The composition according to claim 1, wherein the composition is in a form selected from the group consisting of liquid, lotion, cream or ointment.

51. The composition according to claim 1, further comprising a solubilizer selected from the group consisting of triacetin, polyethylene glycols, polysorbates, poloxamers, polyoxyethylene ethers, polyoxylstearates, polyethoxylated stearates, and tributyrin.

52. The composition according to claim 1, further comprising an esterified long-chain fatty acid selected from the group consisting of lauric acid, palmitic acid, stearic acid, oleic acid, arachidic acid, and linoleic acid.

53. The composition according to claim 1, further comprising one or more amino acid.

54. The composition according to claim 53, wherein the amino acid is a natural amino acid.

55. The composition according to claim 53, wherein the amino acid is selected from the group consisting of alanine, asparagines, aspartic acid, cysteine, glutamic acid, glutamine, glycine, phenylalanine, histidine, isoleucine, lysine, leucine, methionine, proline, arginine, serine, threonine, valine, tryptophan, and tyrosine.

56. The composition according to claim 53, wherein the amino acid is a combination of alanine, asparagines, aspartic acid, cysteine, glutamic acid, glutamine, glycine, phenylalanine, histidine, isoleucine, lysine, leucine, methionine, proline, arginine, serine, threonine, valine, tryptophan, and tyrosine.

57. The composition according to claim 1, further comprising an extract of earthworm in an amount of 10-90% by weight based on the total weight of the composition, wherein the amount of earthworm is 2-60% by weight based on the total weight of the oil.