Compositions and methods for treating and repairing tendons

• US 10,272,118 B2
• Filed: 02/12/2014
• Issued: 04/30/2019
• Est. Priority Date: 02/12/2013
• Status: Active Grant

• Current Assignee: RepliCel Life Sciences, Inc.
• Original Assignee: RepliCel Life Sciences, Inc.
• Inventors: Hoffmann, Rolf, McElwee, Kevin John
• Primary Examiner(s): Claytor, Renee
• Assistant Examiner(s): Clarke, Trent R
• Application Number:
  US14/767,577
• Publication Number:
  US 20150374757A1
• Time in Patent Office: 1,903 Days
• Field of Search: None
• 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 35/36 Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells islets of Langerhans A61K35/39
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/1808 Epidermal growth factor [EGF] urogastrone
• CPC Class Codes: A61K 38/1825 Fibroblast growth factor [FGF]
• CPC Class Codes: A61K 38/1833 Hepatocyte growth factor; Scatter factor; Tumor cytotoxic factor II
• CPC Class Codes: A61K 38/1841 Transforming growth factor [TGF]
• CPC Class Codes: A61K 38/1858 Platelet-derived growth factor [PDGF]
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 38/204 IL-6
• CPC Class Codes: A61K 38/30 Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2 insulin-like growth factor binding protein A61K38/1754
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: C12N 2501/113 Acidic fibroblast growth factor (aFGF, FGF-1)
• CPC Class Codes: C12N 2501/905 Hyaluronic acid
• CPC Class Codes: C12N 5/0628 Hair stem cells; Hair progenitors mesenchymal stem cells from hair follicles C12N5/0666
• CPC Class Codes: C12N 5/066 Tenocytes; Tendons, Ligaments
• CPC Class Codes: C12N 5/0666 Mesenchymal stem cells from hair follicles

Abstract

The present invention relates to compositions and methods utilizing hair follicle derived Non-Bulbar Dermal Sheath cells for use in the treatment or prevention of the tendon injuries.

Claims

1. A method for treating a tendon injury, comprising administering to a subject in need thereof a composition comprising isolated non-bulbar dermal sheath (NBDS) cells;

where the isolated NBDS cells were produced by a method comprising

(a) preparing vital hair;

(b) cleaving the vital hair prepared in step (a) to remove the hair follicle bulb and obtain an isolated dermal sheath;

(c) isolating NBDS tissue from the dermal sheath produced in step (b); and

(d) cultivating the isolated NBDS tissue of step (c) to produce the isolated NBDS cells.

2. The method according to claim 1 wherein said subject is a mammal selected from the group consisting of humans, horses, dogs and cats.

3. The method according to claim 1 wherein said tendon injury is selected from a complete tendon rupture, a partial tendon rupture, and a micro-tear of a tendon.

4. The method according to claim 1 wherein said tendon injury is selected from the group consisting of tendinosis, tenosynovitis, and avulsion.

5. The method according to claim 1 wherein said tendon is the Achilles tendon or the Patellar tendon.

6. The method according to claim 1 wherein said tendon is a flexor tendon.

7. The method according to claim 1 wherein said tendon is an extensor tendon.

8. The method according to claim 1 wherein said vital hair is obtained by biopsy from the occipital scalp of a subject.

9. The method according to claim 1 wherein said vital hair is cleaved utilizing a micromanipulator and scalpel.

10. The method according to claim 1 wherein producing the isolated NBDS cells comprises conducting enzymatic digestion of the isolated Non-Bulbar Dermal Sheath tissue.

11. The method according to claim 10 wherein said enzymatic digestion is conducted with collagenase.

12. The method according to claim 1 wherein said isolated NBDS cells are cultivated over multiple passages in either serum containing or serum-free media.

13. The method according to claim 1 wherein the composition further comprises at least one of serum and plasma.

14. The method according to claim 1 wherein the composition does not contain either serum or plasma.

15. The method according to claim 1 wherein the composition further comprises at least one component selected from the group consisting of fibrin, hyaluronic acid, a component of the extracellular matrix, cytokine, chemokine and therapeutic agent.

16. The method according to claim 15 wherein said component of the extracellular matrix is selected from the group consisting of glycosaminoglycan (GAG), heparin sulfate, chondroitin sulfate, keratin sulfate, hyaluronic acid, elastin, fibronectin and laminin.

17. The method according to claim 15 wherein said therapeutic agent is selected from the group consisting of analgesic agent, anti-inflammatory agent and immunomodulatory agent.