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Cancellous bone treated with collagenase and essentially free of blood cells

Cancellous bone treated with collagenase and essentially free of blood cells description/claims

This application is a continuation-in part of application Ser. No. 11/799,606, filed May 2, 2007 which claims priority based on provisional application Ser. No. 60/831,723, filed Jul. 18, 2006, and provisional application Ser. No. 60/798,474, filed May 8, 2006, the contents of which are incorporated herein by reference in their entireties.

This invention relates to bone implants comprising cancellous bone useful in the treatment or prevention of bone diseases, disorders, defects, or injuries.

This invention relates to bone implants which include cancellous bone. More particularly, this invention relates to bone implants that include cancellous bone that has been treated with at least one loosening agent in order to loosen osteogenic cells in the bone matrix. The cancellous bone also is essentially free of blood cells.

This invention also relates to bone implants which include the cancellous bone hereinabove described, and demineralized bone. More particularly, this invention also relates to bone implants which include the cancellous bone hereinabove described, and bone, such as, for example, cortical bone, which has been treated with at least one demineralization agent for a time and at a concentration to expose osteoinductive proteins in the bone matrix.

Bone implants which include cancellous bone have been used in a variety of procedures and treatments, including bone fusions such as spine fusions, disc augmentations in the spine, and bone fill applications employed in the treatments of diseases, disorders, or injuries including, but not limited to, avascular osteonecrosis, osteosarcoma, acute fractures and fracture non-unions, as well as for bone regeneration for orthopedic implants. Such bone in general may be harvested from any source of cancellous bone, including vertebrae, the iliac crest, femur, tibia, or ribs.

Cancellous bone implants in general have included, in addition to osteocytes and osteogenic cells, blood cells including hematopoietic cells. In some implants, the implants have been treated in order to preserve the viability of all the cells in the implant, while in other implants, the viability of the bone cells, including the osteogenic cells, has been destroyed.

The present invention provides a bone implant which includes cancellous bone including viable osteogenic cells which are made more available for carrying out their osteogenic function.

In accordance with an aspect of the present invention, there is provided a bone implant comprising cancellous bone. The cancellous bone is essentially free of blood cells, and has been treated with at least one loosening agent for a time and at a concentration to loosen the osteogenic cells in the cancellous bone matrix. The osteogenic cells in the bone matrix are viable cells.

The term “loosening agent” as used herein, means an agent which may be contacted with a bone matrix for a time and at a concentration sufficient to loosen osteogenic cells in the cancellous bone matrix without releasing the osteogenic cells from the cancellous bone matrix. An exemplary loosening agent useful in accordance with the present invention comprises collagenase. Another exemplary loosening agent useful in accordance with the present invention comprises a digestive enzyme. In some embodiments, the digestive enzyme is selected from the group consisting of trypsin, amylase, lipase, and combinations thereof. In some embodiments, the digestive enzyme is trypsin. In some embodiments, the digestive enzyme is amylase. In some embodiments, the digestive enzyme is lipase. Another exemplary loosening agent useful in accordance with the present invention comprises a combination of collagenase and a digestive enzyme for a time and at a concentration to loosen the osteogenic cells contained in the bone matrix, but not release the osteogenic cells from the bone matrix.

The term “osteogenic cell”, as used herein, means any type of cell having osteoprogenitor potential, that is, any type of cell that is capable of differentiating into a bone cell.

The term “D90”, as used herein, refers to the size of the 90th percentile (by number) particle in a cumulative size distribution of all particles sampled.

Although the scope of the present invention is not to be limited to any theoretical reasoning, when the bone implant is essentially free of blood cells and has been treated with a loosening agent in order to loosen the osteogenic cells in the cancellous bone matrix, such osteogenic cells become more available for or are more disposed toward carrying out their osteogenic function, and provide for an increased rate of bone formation. Thus, such bone implants are capable of generating or “growing” bone directly and provide for improved implants vis-a-vis prior art implants, including previously produced cancellous bone implants, and ceramic implants.

The compositions of the present invention are useful in the treatment or prevention of bone diseases, disorders, defects, or injuries.

In one embodiment, the present invention comprises a bone implant that comprises: cancellous bone matrix, said cancellous bone matrix being essentially free of blood cells, said cancellous bone matrix having been treated with at least one loosening agent for a time and at a concentration to loosen osteogenic cells in the cancellous bone matrix, said osteogenic cells in the cancellous bone matrix being viable cells.

In one embodiment, the present invention comprises a bone implant that comprises: (i) cancellous bone matrix, said cancellous bone including cancellous bone which is essentially free of blood cells and having been treated with at least one loosening agent for a time and at a concentration to loosen osteogenic cells in the cancellous bone matrix, said osteogenic cells in the cancellous bone matrix being viable cells; and (ii) cortical bone matrix which has been treated with at least one demineralization agent for a time and at a concentration to expose osteoinductive proteins present in the cortical bone matrix.

In some embodiments, the at least one demineralization agent is hydrochloric acid.

• Provisional Patent
• Utility Patent

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