METHOD OF TREATMENT UTILIZING AN ACELLULAR AMNION DERIVED THERAPEUTIC COMPOSITION

• US 20160199417A1
• Filed: 09/14/2015
• Published: 07/14/2016
• Est. Priority Date: 06/15/2014
• Status: Active Grant

• Current Assignee: Amnio Technology LLC
• Original Assignee: Amnio Technology LLC
• Inventors: Werber, Bruce, Beaudry, Christian, Suddarth, Terrell
• Granted Patent: US 9,814,746 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2800/74 Biological properties of particular ingredients
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 35/35 Fat tissue; Adipocytes; Stromal cells; Connective tissues adipose-derived stem cells A61K35/28; collagen A61K38/39
• CPC Class Codes: A61K 35/44 Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61K 8/982 Reproductive organs; Embryos, Eggs
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/0046 Ear
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: A61Q 19/08 Anti-ageing preparations

Abstract

Acellular amnion derived therapeutic compositions are described having a number of various compositional embodiments. An acellular amnion derived therapeutic composition has essentially no live or active amniotic cells. The amniotic cells may be destroyed, and the cells and cell debris may be removed from the acellular amnion derived therapeutic composition. An acellular amnion derived therapeutic composition may comprise micronized placental tissue particles, and/or amniotic fluid. An acellular amnion derived therapeutic composition may be a dispersion of micronized amniotic membrane combined with a fluid, such as plasma, saline, amniotic fluid, combinations thereof and the like. An acellular amnion derived therapeutic composition may be combined with a matrix component to form a composite. An acellular amnion derived therapeutic composition may be used in conjunction with a composition comprising viable cells, such as stem cells.

Claims

19. A method of treating a treatment location comprising the steps of:

a) providing a therapeutic composition comprising;

i. acellular amniotic membrane particles;

ii. a carrier fluid comprising an acellular amniotic fluid;

wherein the acellular amniotic membrane particles consist essentially of micronized amniotic membrane; and

wherein the therapeutic composition is essentially free of any viable amniotic membrane cells or viable amniotic fluid cells;

b) providing a syringe containing said therapeutic composition;

c) applying the therapeutic composition via injection with the syringe to a treatment location.

1. A method of topically treating an external body treatment location comprising the steps of:

a) providing a therapeutic composition comprising;

i. cellular amniotic membrane particles;

ii. a carrier fluid comprising an acellular amniotic fluid;

wherein the acellular amniotic membrane particles consist essentially of micronized amniotic membrane; and

wherein the therapeutic composition is essentially free of any viable amniotic membrane cells or viable amniotic fluid cells;

b) applying the therapeutic composition topically to said external body treatment location.

2. The method of claim 1, wherein the t treatment location is skin.

3. The method of claim 1, wherein the treatment location is the skin the method of treating is for atopic dermatitis.

4. The method of claim 1, wherein the treatment location is hair or a hair follicle.

5. The method of claim 4, wherein the wherein the method of treating is for local or systemic hair loss.

6. The method of claim 1, wherein the treatment location is an ophthalmic lesion.

7. The method of claim 1, wherein the treatment location is a wound.

8. The method of claim 1, wherein the treatment location is an eye.

9. The method of claim 1, wherein the treatment location is an ear.

10. The method of claim 1, wherein the treatment location is a mouth.

11. The method of claim 1, wherein the treatment location is a mucosal membrane.

12. The method of claim 1, wherein the treatment location is a first degree burn, a second degree burn, or a third degree burn.

13. The method of claim 1, wherein the treatment location is keloid scar, surgical or traumatic induced scar.

14. The method of claim 1, wherein the therapeutic composition comprises at least one of an oil or wax and has a viscosity of at least 5 k cps.

15. The method of claim 1, wherein the therapeutic composition is a cream.

16. The method of claim 1, wherein the therapeutic composition is a lotion.

17. The method of claim 1, wherein the therapeutic composition is an ointment.

18. The method of claim 1, wherein the therapeutic composition is a gel.

20. The method according to claim 19, wherein the treatment location is an articular joint.

21. The method according to claim 19, wherein the treatment location is a muscle.

22. The method according to claim 19, wherein the treatment location is an organ.

23. The method according to claim 19, wherein the treatment location is an eye and associated ophthalmic structures.

24. The method according to claim 19, wherein the treatment location is in or around a penis and the method of treating is for erectile dysfunction or peyronie'"'"'s disease.

25. The method according to claim 19, wherein the treatment location is in or around a vagina and the method of treating is for vaginal rejuvenation.

26. The method according to claim 19, wherein the treatment location is a spine or surrounding region of the spine and the method of treating is for treatment of a degenerative process.

27. The method according to claim 19, wherein the treatment location is a soft tissue.

29. The method according to claim 19, wherein the treatment location is a bone and the method of treating is to enhance a rate of healing of said bone.

30. The method according to claim 19, wherein the treatment location is a tooth.

26-1. The method according to claim 19, wherein the treatment location is an artery or a vein.

31. A method of intravenously or intra-arterial or cerebrospinal treating a patient with a therapeutic composition comprising the steps of:

a) providing a therapeutic composition comprising;

i. acellular amniotic membrane particles;

ii. a carrier fluid comprising an acellular amniotic fluid;

wherein the acellular amniotic membrane particles consist essentially of micronized amniotic membrane; and

wherein the therapeutic composition is essentially free of any viable amniotic membrane cells or viable amniotic fluid cells;

b) providing an intravenous, an Intra-arterial or cerebrospinal system comprising;

i. a venous, an arterial or a cerebral access port, respectively; and

ii. a treatment solution reservoir comprising said therapeutic composition;

c) coupling the access port to a patient'"'"'s venous, arterial, cardiac or cerebrospinal system;

d) dispensing the treatment solution into the patient'"'"'s venous, arterial, cardiac or cerebrospinal system to treat the patient with the therapeutic composition intravenously.

32. The method of claim 31, wherein the method of treating is for a systemic condition selected from the group consisting of:

neurologic origin including dementia and Alzhiemers and neuromuscular in origin including lou gehrig'"'"'s disease, ALS, multiple sclerosis, and Parkinsons.

33. The method of claim 31, wherein the method of treating is for an immunomodulated (autoimmune) disorder or disease selected from the group consisting of lupus erythematosus, sero (+) (−

) arthritis, ulcerative colitis, chronic fatigue syndrome, and fibromyalgia.

34. The method of claim 31, wherein the method of treating is for a cardiac related disease or disorder selected from the group consisting of:

myocardial infarction, atrial fibrillation, congestive heart failure, endocarditis, and cardiomyopathy.

35. The method of claim 31, wherein the method of treating is for a urologic disorder urologic disease.

36. The method of claim 31, wherein the method of treating is for a kidney disorder or a kidney disease

37. The method of claim 31, wherein the method of treating is for a bladder disorder or disease.

38. The method of claim 31, wherein the method of treating is for a liver disorder or disease.

39. A method of claim 31, wherein the method of treating is for a brain disorder or disease

40. A method of claim 31, wherein the method of treating is for a blood disorder or disease

41. A method of claim 31, wherein the method of treating is for a heart disorder or disease

42. A method of claim 31, where the method of treating is for a neuromuscular disease or disorder.

43. The method of claim 31, wherein the method of treating is for a pulmonary disorder selected from the group consisting of:

COPD, asthma, chronic obstructive pulmonary disease, idiophathic pulmonary fibrosis, alveolitis, chronic parenchymal lung disease, pleural lung disease, trans-bronchial parenchymal disease or post-operative lung recovery and scaring.

44. A method of claim 31, wherein the therapeutic composition is introduced into a pulmonary artery.

45. A method of claim 31, wherein the therapeutic composition is introduced through a central venous catheter.

46. A method of claim 31, wherein the therapeutic composition is introduced through a trans-bronchial catheter.

47. A method of claim 31, wherein the therapeutic composition is introduced though a peripheral venous catheter.

48. A method of treating a treatment location intraoperatively with a therapeutic composition comprising the steps of:

a) providing a therapeutic composition comprising;

i. acellular amniotic membrane particles;

ii. a carrier fluid comprising an acellular amniotic fluid;

wherein the acellular amniotic membrane particles consist essentially of micronized amniotic membrane; and

wherein the therapeutic composition is essentially free of any viable amniotic membrane cells or viable amniotic fluid cells;

b) applying the therapeutic composition intraoperatively to a treatment location.

49. The method of claim 48, wherein the treatment location is an organ.

50. The method of claim 48, wherein the treatment location is an operative incision.

51. The method of claim 48, wherein the step of applying the therapeutic composition comprises topically applying the therapeutic composition to a treatment location.

52. The method of claim 48, wherein the step of applying the therapeutic composition comprises injecting the therapeutic composition with a syringe into a treatment location.

53. A method of orally treating a patient with a therapeutic composition, comprising the steps of:

a) providing a therapeutic composition comprising;

i. acellular amniotic membrane particles;

ii. a carrier fluid comprising an acellular amniotic fluid;

wherein the acellular amniotic membrane particles consist essentially of micronized amniotic membrane; and

iii. wherein the therapeutic composition is essentially free of any viable amniotic membrane cells or viable amniotic fluid cells

b) administering the therapeutic composition orally.

54. The method of claim 53, wherein the therapeutic composition is a liquid, a capsule, or a tablet.

55. The method of claim 53, wherein the method of orally treating is for a gastrointestinal disorder or disease.

56. The method of claim 53, wherein method of orally treating is for a stomach disorder or disease.

57. The method of claim 53, wherein method of orally treating is for a stomach ulcer.

58. The method of claim 53, wherein method of orally treating is for crohn'"'"'s disease.

59. The method of claim 53, wherein the method of orally treating is for a gastrointestinal polyp.