Preparations Containing Hepatocyte Growth Factor and Hyaluronic Acid and Methods of Making and Using Same

• US 20140274899A1
• Filed: 03/14/2014
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Prime Merger Sub LLC (Alight, Inc.)
• Original Assignee: NuTech Spine, Inc.
• Inventors: Walthall, Howard P. Jr.
• Granted Patent: US 9,511,119 B2
• Time in Patent Office: Days
• US Class Current: 514/9.5
• CPC Class Codes: A61K 2800/91 Injection
• CPC Class Codes: A61K 38/1833 Hepatocyte growth factor; Scatter factor; Tumor cytotoxic factor II
• CPC Class Codes: A61K 8/64 Proteins; Peptides; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/735 Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 2430/10 for reconstruction of tendons or ligaments
• CPC Class Codes: A61L 2430/24 for joint reconstruction
• CPC Class Codes: A61L 2430/32 for nerve reconstruction
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61Q 19/08 Anti-ageing preparations
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

Preparations containing hepatocyte growth factor (HGF) and hyaluronic acid (HA) and methods of making and using same. The HGF and HA preparations can be prepared together in solution as an injectable fluid without gelatinization, or impregnated within a porous hydrophilic matrix material with, or without, cross-linking of the HA with the matrix material. The preparations can be used as a dermal filler or to generate and promote healing of cartilage, vertebral discs, connective tissues such as tendons and ligaments and bone in vivo.

Claims

1. A method of treating a mammal comprising:

providing a preparation including human growth factor (HGF) and hyaluronic acid (HA), and

introducing the preparation into a synovial joint of the mammal.

2. The method according to claim 1 wherein the preparation is injected into the synovial joint.

3. The method according to claim 1 wherein the synovial joint includes a chondral defect.

4. The method according to claim 1 wherein the synovial joint includes a meniscal defect.

5. The method according to claim 1 wherein the synovial joint presents with osteoarthritis.

6. The method according to claim 1 wherein introducing the preparation into the synovial joint promotes hyaline cartilage regeneration in the synovial joint.

7. The method according to claim 1 wherein the presence of HA in the preparation slows a rate of HGF degradation in the preparation.

8. The method according to claim 1 wherein the presence of HA in the preparation slows a rate of HGF degradation in vivo.

9. The method according to claim 1 where the HA is derived from a recombinant system.

10. The method according to claim 1 further comprising excluding gelatin from the preparation.

11. The method according to claim 1 further comprising excluding a synthetic polymer from the preparation.

12. The method according to claim 1 further comprising injecting the preparation into a synovial joint capsule subsequent to a reparative surgery of the synovial joint thereby increasing incorporation of a graft.

13. A preparation, the active components thereof consisting of human growth factor (HGF) and hyaluronic acid (HA).

14. A method of treating a mammal comprising introducing the preparation of claim 13 into a synovial joint of the mammal.

15. A method of treating a mammal comprising introducing the preparation of claim 13 into the mammal as a dermal filler.

16. A method of treating a mammal comprising regenerating a diseased or damaged tissue by applying the preparation of claim 13 to the diseased or damaged tissue.

17. A method of treating a mammal comprising injecting the preparation of claim 13 into a diseased or damaged tissue.

18. The method according to claim 17 wherein the diseased or damaged tissue is connective tissue.

19. The method according to claim 17 wherein the diseased or damaged tissue includes a tendon or a ligament.

20. The method according to claim 17 wherein the preparation is injected into the diseased or damaged tissue following a reparative surgery to the diseased or damaged tissue.

21. The method according to claim 17 further comprising injecting the preparation into a joint capsule.

22. The method according to claim 17 further comprising injecting the preparation into a nerve.

23. The method according to claim 17 further comprising injection the preparation into or around a wound bed for stimulating healing.

24. The method according to claim 17 further comprising injecting the preparation into or around a diseased or damaged bone thereby promoting healing of the diseased or damaged bone.

25. The method according to claim 17 further comprising injecting the preparation into a diseased or damaged muscle thereby promoting healing of the diseased or damaged muscle.

26. The method according to claim 17 further comprising injecting the preparation into an intervertebral disc of the patient thereby promoting healing of the intervertebral disc.

27. A method of treating a mammal comprising:

providing a preparation including human growth factor (HGF) and hyaluronic acid (HA), wherein the HA is provided in an amount sufficient to decrease a rate of degradation of the HGF in the preparation and in vivo,

introducing the preparation to a tissue of the mammal, the tissue including a diseased or damaged tissue portion and being selected from the group consisting of cartilage tissue, nerve tissue, bone tissue, vertebral disc tissue, muscle tissue and connective tissue,

whereby introducing the preparation to the tissue of the mammal promotes healing of the tissue.

28. The method according to claim 27 wherein, when the preparation is essentially free of gelatin, injecting the preparation into the tissue.

29. The method according to claim 27 further comprising applying the preparation to a porous matrix and placing the porous matrix in the tissue.

30. The method according to claim 29 wherein the HA is incorporated into and cross-linked in situ within the porous matrix with essentially no chemical cross-linking of the HA with the porous matrix.