Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1998-01-13
2001-01-30
Low, Christopher S. F. (Department: 1653)
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
06180606
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. The term osteogenic commonly refers to substances which are osteoconductive and/or osteoinductive.
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. Generally, these materials are referred to as osteoconductive.
Subsequent approaches have used bone repair matrices containing bioactive proteins which when implanted into a bone defect provided not only a scaffolding for invasive bone ingrowth, but active induction of bone cell replication and differentiation. These materials are generally referred to as osteoinductive.
In general, osteoinductive compositions comprised a matrix which provided the scaffolding for invasive growth of the bone, 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); inorganically based materials, 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).
Osteogenic compositions and methods 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 may be enhanced by crosslinking with glutaraldehyde.
In particular, two specific substances have a well established ability to induce the formation of new bone (i.e., to be osteoinductive) 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).
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. Osteogenic bone repair compositions in accordance with this invention are used as implants, to repair, form, or regenerate bone in the treatment of osseous or periodontal defects. An osseous or periodontal defect is an osseous or periodontal location, respectively, where generation of osseous tissue is therapeutically beneficial or cosmetically desired.
Osteogenic compositions in accordance with the invention can 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 are on or within the matrix of the osteogenic composition, and/or on or within the osteoinductive factor of the composition. 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.
It is a more specific object of this invention to provide an improved osteogenic composition comprising a porous or semi-porous collagen matrix and either demineralized bone particles or Bone Morphogenetic Proteins, or proteins, and the growth factor TGF-&bgr;2.
It is a further object of this invention to provide improved osteogenic compositions comprising a porous or semi-porous matrix, at least one osteogenic factor, and at least one nutrient factor.
It is yet another object of this invention to provide improved osteogenic compositions comprising a porous or semi-porous matrix, at least one osteogenic factor, and at least one drug.
It is yet another object of this invention to provide improved osteogenic compositions comprising a porous or semi-porous matrix, at least one osteogenic factor, wherein at least one antimicrobial, blood protein or product, or calcium containing compound is present on or within the matrix, and/or on or within the osteoinductive factor.
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 will become apparent from the description that follows.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to osteogenic compositions having enhanced osteogenic potential. Thus, the invention relates to osteogenic compositions having enhanced osteogenic potential which comprise a porous or semi-porous matrix, at least one osteoinductive factor, and a growth factor, nutrient factor, drug, calcium containing compound, antimicrobial agent, blood protein or products, or combinations thereof.
The osteogenic compositions in accordance with the invention can comprise a porous or semi-porous matrix and at least one osteoinductive factor, wherein at least one growth factor is present on or within the matrix, and/or on or within the osteoinductive factor. Thus, the osteoinductive factor can be the growth factor, whereby the composition has two components, a matrix and an osteoinductive growth factor.
Alternatively, osteogenic compositions in accordance with the invention can comprise a porous or semi-porous matrix, at least one osteoinductive factor, wherein at least one nutrient factor is present on or within the matrix, and/or on or within the osteoinductive factor. Thus, the matrix can be the nutrient factor, whereby the composition has two components, a matrix and an osteoinductive factor.
Preferred embodiments of the compositions in accordance with the invention were determined based on an observation that specific combinations of osteoinductive factors and growth factors have a synergistic effect in enhancing bone repair. Alternative preferred embodiments of the invention comprise osteogenic compositions which comprise various combinations of a matrix; osteoinductive factor(s); and, nutrient factors, drugs, antimicrobial agents, calcium containing compounds, blood proteins or products or other agents which result in enhanced hard tissue healing or bone repair.
A Porous or Semi-Porous Matrix
Compositions comprising a porous or semi-porous matrix and one or more osteoinductive elements are comprised of materials known in the art and prepared by known methods. The growth factors, nutrient factors, or other agents may be present within or on the matrix or reside in a matrix void. When an agent is comprised by the matrix, it is covalently attached to the matrix, or is encompassed by the matrix void space; in these situations, the agent will generally be referred to as within the matrix.
The matrix may comprise organic materials; inorganic materials, such as ceramics; o
Chen Charles C.
Jefferies Steven R.
GenSci OrthoBiologics, Inc.
Howrey Simon Arnold & White
Low Christopher S. F.
Mohamed Abdel A.
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