Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1998-01-05
2001-01-30
Low, Christopher S. F. (Department: 1654)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S021800, C514S801000, C424S085100, C424S422000, C424S423000, C424S424000, C530S351000, C530S356000, C530S399000, C530S840000, C128SDIG008
Reexamination Certificate
active
06180605
ABSTRACT:
FIELD OF THE INVENTION
This invention is in the field of osteogenic bone repair compositions. More specifically this invention relates to bone repair compositions having enhanced osteogenic potential, to methods for making these bone repair compositions having enhanced osteogenic potential and to therapeutic uses for these compositions.
BACKGROUND OF THE INVENTION
A variety of methods and compositions of biomaterials have been used to repair or regenerate bone loss due to either trauma or disease. Conventional implantable bone repair materials provided a matrix or scaffolding for migration into, proliferation and subsequent differentiation of cells responsible for osteogenesis (Nashef U.S. Pat. No. 4,678,470). While the compositions provided by this approach provided a stable structure for invasive bone growth they did not promote bone cell proliferation or bone regeneration. Subsequent approaches have used bone repair matrices containing bioactive proteins which when implanted into the bone defect provided not only a scaffolding for invasive bone ingrowth, but active induction of bone cell replication and differentiation. In general these osteoinductive compositions are comprised of a matrix which provides the scaffolding for invasive growth of the bone, and anchorage dependent cells and an osteoinductive protein source. The matrix may be a variety of materials, such as collagen (Jefferies U.S. Pat. Nos. 4,394,370 and 4,472,840) or inorganically based, such as a biodegradable porous ceramic (Urist U.S. Pat. No. 4,596,574) or polylactic acid (Urist U.S. Pat. No. 4,563,489). In particular, two specific substances have been well established in their ability to induce the formation of new bone through the process of osteogenesis: demineralized bone particles or powder, and bone morphogenetic proteins (BMPs) (Urist U.S. Pat. Nos. 4,595,574, 4,563,489, 4,551,256). A variety of other bone inducing factors have been characterized as well (Seydin et al., U.S. Pat. No. 4,627,982).
Osteogenic compositions and method for making the same are described in Jefferies U.S. Pat. Nos. 4,394,370 and 4,472,840. Jefferies describes complexes of reconstituted collagen and demineralized bone particles or complexes of reconstituted collagen and a solubilized bone morphogenetic protein, fabricated into a sponge suitable for in vivo implantation into osseus defects. Structural durability of these compositions is enhanced by crosslinking with glutaraldehyde. While a wide variety of osteoinductive compositions have been used in bone repair and regeneration there is always need in the art for improvements or enhancements of existing technologies which would accelerate and enhance bone repair and regeneration allowing for a faster recovery for the patient receiving the osteogenic implants.
SUMMARY OF THE INVENTION
This invention relates to bone repair compositions having enhanced osteogenic potential. The osteogenic-bone repair composition of this invention are used as implants to repair, form, or regenerate bone in the treatment of osseous or periodontal defects. These improved osteogenic compositions provided herein comprise a porous or semi-porous matrix and at least one osteogenic factor, wherein one or more growth factors, drugs, nutrients, antimicrobial agents, blood proteins or products, or calcium containing compounds have been sorbed onto or into the matrix of the osteogenic composition complexed with the osteoinductive factor. The osteogenic bone repair material of this invention, produced by the methods described herein, exhibit enhanced osteogenic potential relative to known osteogenic bone repair compositions used as implants to repair bone defects.
It is a general object of this invention to provide improved osteogenic compositions comprising a porous or semi-porous matrix and at least one osteogenic factor, wherein at least one growth factor has been sorbed into or onto the matrix.
It is a more specific object of this invention to provide a improved osteogenic composition comprising a porous or semi-porous collagen matrix and either demineralized bone particles or Bone Morphogenic Proteins, or proteins wherein the growth factor TGF-&bgr;2 has been sorbed onto or into the matrix.
It is a further object of this invention to provide improved osteogenic compositions comprising a porous or semi-porous matrix and at least one osteogenic factor, wherein at least one nutrient factor has been sorbed onto or into the matrix.
It is yet another object of this invention to provide improved osteogenic compositions comprising a porous or semi-porous matrix and at least one osteogenic factor wherein at least one drug has been sorbed onto or into the matrix.
It is yet another object of this invention to provide improved osteogenic compositions comprising a porous or semi-porous matrix and at least one osteogenic factor wherein a at least one antimicrobial, blood protein or product, or calcium containing compound has been sorbed onto or into the matrix.
It is a further object of this invention to provide methods of making the improved osteogenic compositions.
It is yet a further object of this to provide methods of use for these improved osteogenic compositions in the repair of osseous or periodontal defects.
Further objects and advantages of the present invention as will become apparent from the description that follows.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to osteogenic compositions having enhanced osteogenic potential. The compositions having enhanced osteogenic potential provided herein are based on an observation by the inventor that specific combinations of osteoinductive factors and growth factors have a synergistic effect in enhancing bone repair. This present invention further relates to osteogenic composition having enhanced osteogenic potential comprising combinations of osteoinductive factors and, nutrient factors, drugs, antimicrobial agents, calcium containg compounds, blood proteins or products or other agents which result in enhanced hard tissue healing or bone repair.
The osteogenic compositions provided herein and having enhanced osteogenic potential are comprised of a porous or semi-porous matrix and at least one osteoinductive factor, wherein at least one growth factor has been sorbed into or onto the matrix. Composition comprising a porous or semi-porous matrix and a osteoinductive element are comprised of materials known in the art and prepared by known methods. The matrix may be comprised of organic, materials, inorganic materials, such as ceramics, or synthetic polymers. Examples of organic materials that can be used to form the matrix include, but are not limited to, collagen, polyamino acids, or gelatin. The collagen source maybe allogenic, or xenogeneic relative to the mammal receiving the implants. The collagen may also be in the form atelopeptide or telopeptide collagen. Example of synthetic polymers that can be used to form the matrix include, but are not limited to, polylactic acids, polyglycolic acids, or combinations of polylactic/polyglycolic acids. Resorbable polymers, as well as non-resorbable polymers such as may constitute the matrix material. One of skill in the art will appreciate that the terms porous or semi-porous refers to the varying density of the pores in the matrix. One of skill in the art will also appreciate that inorganic fillers or particles, such as hydroxyapatite, tri-calcium phosphate, ceramic glasses such as Bioglass, amorphous calcium phosphates, porous ceramic particles or powders, mesh or particulate titanium or titanium alloy may also be added to the organic or synthetic matrix. Mineralized or partially mineralized freeze-dried, particulate bone may also be used for this purpose.
Examples of osteogenic factors that may be complexed with the matrix include, but are not limited to demineralized bone particles, Bone Morphogenetic Proteins (BMP), such as BMP-2 and BMP-7, and other osteoinductive factors such as extracts of demineralized bone matrix. Examples of other BMPs which may be complexed with the matrix by conventio
Chen Charles C.
Jeffries Steven R.
GenSci OrthoBiologics, Inc.
Howrey Simon Arnold & White
Low Christopher S. F.
Mohamed Abdel A.
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