Bone repair product and methods of use thereof

Patent metadata

Field	Value
Publication number	US-12343446-B2
Application number	US-202217698602-A
Country	US
Kind code	B2
Filing date	Mar 18, 2022
Priority date	Sep 19, 2014
Publication date	Jul 1, 2025
Grant date	Jul 1, 2025

Abstract

Provided herein is a bone repair composition that is composed of periosteum containing an angiogenic growth factor(s), cancellous bone chips containing viable osteogenic cells, and, optionally, demineralized bone matrix (DBM) chips. Also provided herein are articles of manufacture and methods of use thereof to treat bone defects.

First claim

What is claimed is:

1. A method of repairing a bone defect, the method comprising administering to the site of the bone defect a bone repair composition comprising:
(a) cancellous bone chips comprising viable cells, wherein the cancellous bone chips are not processed with a loosening agent,
(b) 5-20 wt. % devitalized and non-immunogenic periosteum pieces, based on the total weight of the composition, and
(c) demineralized bone matrix (DBM) chips,
wherein one or more growth factors comprised in the composition promote angiogenesis at the site of the bone defect.

2. The method of claim 1 , wherein the cancellous bone chips are from long bone.

3. The method of claim 2 , wherein the long bone is femur and tibia.

4. The method of claim 1 , wherein the cancellous bone chips are less than 4 mm in size.

5. The method of claim 4 , wherein the cancellous bone chips are from about 125 μm to 4 mm or from about 125 μm to 3 mm in size.

6. The method of claim 1 , wherein the periosteum pieces are from long bone.

7. The method of claim 1 , wherein the periosteum pieces adhere to themselves and to the bone chips.

8. The method of claim 1 , wherein the DBM chips are from cortical bone.

9. The method of claim 1 , wherein the viable cells are osteogenic cells.

10. The method of claim 9 , wherein the osteogenic cells comprise one or more of mesenchymal stem cells, osteoprogenitor cells, osteoblasts, or osteocytes.

11. The method of claim 1 , wherein the one or more growth factors are angiogenic growth factors.

12. The method of claim 1 , wherein the one or more growth factors are osteogenic growth factors.

13. The method of claim 1 , wherein the one or more growth factors comprise vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), platelet-derived growth factor-BB (PDGF-BB), basic fibroblast growth factor (bFGF), insulin-like growth factor-I and -II (IGF-I and IGF-II), transforming growth factor-beta (TGF-β), bone morphogenetic protein (BMP), or parathyroid hormone (PTH).

14. The method of claim 13 , wherein the transforming growth factor-beta is TGF-β 1 .

15. The method of claim 13 , wherein the bone morphogenetic protein is BMP-2, BMP-4, BMP-6, BMP-7, or BMP-9.

16. The method of claim 1 , wherein the composition is sterilized.

17. The method of claim 16 , wherein the composition is sterilized by gamma irradiation, electron beam irradiation, or ethylene oxide treatment.

18. The method of claim 1 , wherein the composition is preserved.

19. The method of claim 18 , wherein the composition is preserved in a preservation medium comprising one or more of polyvinyl pyrrolidone, a polysaccharide, a monosaccharide, an alginate, trehalose, raffinose, dextran, human serum albumin, ficoll, lipoproteins, or hydroxyethyl starch.

20. The method of claim 19 , wherein the preservation medium comprises trehalose.

21. The method of claim 18 , wherein the composition is preserved by cryopreservation or vitrification.

22. The method of claim 21 , wherein the composition is preserved in a cryopreservation or vitrification medium comprising one or more of dimethyl sulfoxide (DMSO), glycerol, a glycol, propylene glycol, ethylene glycol, propanediol, polyethylene glycol (PEG), or 1,2-propanediol.

23. The method of claim 22 , wherein the composition is preserved in a cryopreservation or vitrification medium comprising DMSO.

24. The method of claim 1 , wherein the repair is associated with hip replacement operations, knee replacement operations, foot and ankle surgeries, spinal fusion procedures, repair of periodontal defects, treatment of osteoporotic fractures, repair of bone tumor defects, repair of cranial maxilla facial defects, general arthroplasty, cup arthroplasty of the hip, femoral and humeral head replacement, temporomandibular joint replacement, total joint replacement, repairs of the vertebral column, alveolar ridge augmentation and reconstruction, inlay bone grafts, implant placement and revision or sinus lifts, or repair of bone fractures or defects.

25. The method of claim 1 , wherein the bone defect is a simple fracture, compound fracture, external fixation, internal fixation, joint reconstruction, arthroplasty, degenerative disc disease, avascular osteonecrosis, non-union fracture, osteosarcoma fracture, avascular osteonecrosis, bone fusion, spinal fusion, disc augmentation, or bone regeneration in orthopedic implants.

Assignees

• Osiris Therapeutics Inc

Inventors

• Uveges Thomas E
• Kuang Jin-Qiang
• Danilkovitch Alla
• Sinclair S Michael
• Geraghty Sandra D

Classifications

• A61L27/3687

  characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents · CPC title

• A61L27/3604

  characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel · CPC title

• A61K38/1866

  Vascular endothelial growth factor [VEGF] · CPC title

• A61L27/40

  Composite materials, i.e. containing one material dispersed in a matrix of the same or different material · CPC title

• A61L27/3683

  subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment · CPC title