Methods of Preparing and Using Novel Stem Cell Compositions and Kits Comprising the Same

• US 20070274960A1
• Filed: 10/07/2004
• Published: 11/29/2007
• Est. Priority Date: 10/08/2003
• Status: Active Grant

• Current Assignee: Vetstem Incorporated
• Original Assignee: Vet-Stem, Inc.
• Inventors: Sand, Theodore, Harman, Robert
• Granted Patent: US 9,453,202 B2
• Time in Patent Office: Days
• US Class Current: 424/93.700
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• 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: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: C12N 2509/00 Methods for the dissociation of cells, e.g. specific use of enzymes
• CPC Class Codes: C12N 2509/10 Mechanical dissociation
• CPC Class Codes: C12N 5/0667 Adipose-derived stem cells [ADSC]; Adipose stromal stem cells

Abstract

The present invention provides novel stem cell compositions having significant therapeutic and practical advantages, as well as methods of preparing and using such compositions for the treatment and prevention of injury and disease in patients. The invention may be applied to stem cell populations isolated from a wide variety of animals, including humans, and tissues. In particular applications, the invention is used to prepare a stem cell composition from a collagen-based tissue, such as adipose tissue, isolated from a patient, and the stem cell composition is subsequently provided to a site of actual or potential injury in the patient. The invention further includes related kits comprising the stem cell compositions, which are remarkably stable and retain viability and efficacy during storage and shipment.

Claims

1. A method of preparing a purified cell population comprising stem cells for introducing into a patient, comprising:

(a) obtaining adipose tissue from said patient;

(b) processing said adipose tissue to separate cells therein from other tissue components; and

(c) purifying the separated cells from other tissue components;

wherein said method does not include isolating stem cells from other purified cells, thereby preparing a purified cell population comprising adipose tissue-derived stem cells.

2. The method of claim 1, wherein said purified cell population further comprises one or more cells selected from the group consisting of:

red blood cells, white blood cells, fibroblasts, fibroblast-like cells, neutrophils, monocyte/macrophages, and basophils.

3. The method of claim 1, wherein said purified cell population further comprises one or more tissue components selected from the group consisting of:

extracellular matrix polypeptides or fragments thereof, proteoglycans, cytokines, and growth factors.

20. The method of claim 1, wherein said adipose tissue is obtained from the tail head region of the animal.

4-19. -19. (canceled)

21. A method of preparing a composition comprising purified adipose tissue-derived stem cells for introducing into an animal, comprising:

(a) obtaining adipose tissue from the tail head region of said animal;

(b) processing said adipose tissue to separate cells therein from other tissue components; and

(c) purifying the separated cells from other tissue components,

thereby preparing a composition comprising purified adipose tissue-derived stem cells.

22. The method of claim 21, wherein said composition further comprises one or more cells selected from the group consisting of:

red blood cells, white blood cells, fibroblasts, fibroblast-like cells, neutrophils, monocyte/macrophages, and basophils.

23. The method of claim 21, wherein said composition further comprises one or more tissue components selected from the group consisting of:

extracellular matrix polypeptides or fragments thereof, proteoglycans, cytokines, and growth factors.

24-31. -31. (canceled)

32. A method of providing a composition comprising purified stem cells for introducing into a patient, comprising:

(a) processing collagen-based tissue obtained from a patient to separate cells therein from other tissue components;

(b) purifying the separated cells; and

(c) placing said separated cells in a container, thereby providing a composition comprising purified stem cells.

37. The method of claim 32, wherein said collagen-based tissue is adipose tissue or umbilical cord matrix.

38. The method of claim 32, wherein said method does not include isolating stem cells from other purified cells.

33-36. -36. (canceled)

39-47. -47. (canceled)

48. A kit useful in the treatment or prevention of an injury or disease in an animal, comprising:

a container comprising a composition comprising a stem cell population purified from a collagen-based tissue obtained from an animal.

51. The kit of claim 48, wherein said container is a syringe or cryovial.

55. The kit of claim 48, wherein said collagen-based tissue was obtained from the animal to be treated.

59. The kit of claim 48, wherein said collagen-based tissue is adipose tissue obtained from the tail head region of the animal.

49. (canceled)

50. (canceled)

52-54. -54. (canceled)

56-58. -58. (canceled)

60-79. -79. (canceled)

80. A method of preparing a purified cell population comprising collagen-based tissue-derived stem cells for delivery to a patient, comprising:

(a) obtaining collagen-based tissue from said patient;

(b) processing said collagen-based tissue to separate cells therein from other tissue components; and

(c) purifying the separated cells,

wherein said processing comprises contacting said collagen-based tissue with a series of screens, thereby preparing a purified cell population comprising collagen-based tissue-derived stem cells.

81-95. -95. (canceled)

96. A method of preparing a purified cell population comprising collagen-based tissue-derived stem cells for providing to a patient, comprising:

(a) obtaining collagen-based tissue from said patient; and

(b) processing said collagen-based tissue to isolate cells therein from other tissue components,

wherein said processing comprises contacting the tissue with a surface to which the tissue adheres, thereby preparing a purified cell population comprising collagen-based tissue-derived stem cells.

97-113. -113. (canceled)

114. A device adapted for preparing a cell population comprising collagen-based tissue-derived stem cells, comprising a series of mesh screens, arrayed such that one or more of the screens may be separated from each other while in contact with a collagen-based tissue sample.

115-118. -118. (canceled)

119. A method of treating or preventing an injury or disease in a patient, comprising providing to said patient a composition comprising stem cells purified from a collagen-based tissue, wherein said stem cells have not been isolated from other purified cells.

128. The method of claim 119, wherein said injury is selected from the group consisting of:

sprain, strain, dislocation, bruising, tear, and fracture.

120-127. -127. (canceled)

129-150. -150. (canceled)