EP0309241A2 — Inductive collagen-based bone repair preparations

Claim 1

Independent Claim 110 words

A process for preparing a hypoimmunogenic composition suitable for implantation to effect bone repair in a vertebrate wherein the composition comprises an osteoinductively effective amount of a protein osteoinductive factor (OF), which OF is sufficiently pure to be hypoimmunogenic in a xenogeneic host, and a carrier having components which consist essentially of mineral constituting 60-98% and collagen constituting 2-40% of the composition, which process comprises: (a) preparing a uniform suspension in water of the collagen, mineral, and OF components of the composition so that the concentration of collagen in the suspension is 30-100 mg/ml; and (b) subjecting the suspension to controlled drying under ambient pressure to obtain a rigid solid.

Claim 2

Dependent Claim 110 words

A process for preparing a hypoimmunogenic composition suitable for implantation to effect bone repair in a vertebrate wherein the composition comprises an osteoinductively effective amount of a protein osteoinductive factor (OF), which OF is sufficiently pure to be hypoimmunogenic in a xenogeneic host, and a carrier having components which consist essentially of mineral constituting 60-98% and collagen constituting 2-40% of the composition, which process comprises: (a) preparing a uniform suspension in water of the collagen, mineral, and OF components of the composition so that the concentration of collagen in the suspension is 30-100 mg/ml; and (b) subjecting the suspension to controlled drying under ambient pressure to obtain a rigid solid.

Claim 3

Dependent Claim 22 words

The process of claim 1 wherein the drying is continued until the solid has a compressive modulus of at least 20 N/cm².

Claim 4

Dependent Claim 18 words

A process of claim 1 or claim 2, which further includes heat curing of the product of (b).

Claim 5

Dependent Claim 16 words

The process of claim 3 wherein the heat curing is conducted at 50-120°C for 4-168 hours.

Claim 6

Dependent Claim 45 words

The process of any one of the preceding claims wherein the suspension of (a) is prepared by mixing a dilute solution of OF with mineral particles, drying the mixture, and mixing the dried mixture with reconstituted atelopeptide fibrillar collagen suspension containing 30-100 mg/ml of collagen.

Claim 7

Dependent Claim 51 words

A process of any one of claims 1 to 4 wherein the suspension of (a) is prepared by adding a solution of OF to collagen in solution, precipitating the collagen and OF, resuspending the precipitate to a collagen concentration of 10-100 mg/ml, and then mixing the resulting suspension with mineral particles.

Claim 8

Dependent Claim 67 words

A hypoimmunogenic composition suitable for implantation to effect bone repair in a vertebrate, which consists essentially of 60-98% mineral particles; 2-40% of atelopeptide hypoimmunogenic collagen; and an effective amount of an OF preparation, wherein the implant is a porous rigid solid of compressive modulus greater than 20 N/cm², is homogeneous with respect to its components, and wherein the OF is in a biologically active and available form.

Claim 9

Dependent Claim 67 words

A hypoimmunogenic composition suitable for implantation to effect bone repair in a vertebrate, which consists essentially of 60-98% mineral particles; 2-40% of atelopeptide hypoimmunogenic collagen; and an effective amount of an OF preparation, wherein the implant is a porous rigid solid of compressive modulus greater than 20 N/cm², is homogeneous with respect to its components, and wherein the OF is in a biologically active and available form.

Claim 10

Dependent Claim 20 words

The composition of claim 7,wherein the effective amount of OF preparation is 0.5-4% of partially purified OF or its equivalent.

Claim 11

Dependent Claim 51 words

A hypoimmunogenic composition suitable for implantation to effect bone repair in a vertebrate which comprises an osteoinductively effective amount of a protein osteoinductive factor (OF) derived from bone, which OF is sufficiently pure to be hypoimmunogenic in a xenogeneic host, said composition containing at least 75% by weight of mineral carrier.

Claim 12

Dependent Claim 51 words

A hypoimmunogenic composition suitable for implantation to effect bone repair in a vertebrate which comprises an osteoinductively effective amount of a protein osteoinductive factor (OF) derived from bone, which OF is sufficiently pure to be hypoimmunogenic in a xenogeneic host, said composition containing at least 75% by weight of mineral carrier.

Claim 13

Dependent Claim 158 words

The hypoimmunogenic composition of claim 9 selected from the group consisting of (a) a composition which is 87.5% bone collagen powder and 10% non-fibrillar collagen, and wherein the amount of OF corresponds to that obtained by including between about 2.5% by weight of the implant as partially purified OF; (b) a composition which is 85-95% mineral carrier, 5-15% atelopeptide collagen, and wherein the amount of OF corresponds to that obtained by including between about 0.5% and 4% by weight of the implant of partially purified OF; (c) a composition which is 87.5% TCP/HA mixture and 10% non-fibrillar collagen, and wherein the amount of OF corresponds to that obtained by including about 2.5% by weight of the implant as partially purified OF; and (d) a composition which is 91.5% TCP/HA mixture and 6% reconstituted fibrillar collagen, and wherein the amount of OF corresponds to that obtained by including about 2.5% by weight of the implant as partially purified OF.

Inductive collagen-based bone repair preparations

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