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|Title:||Delivery system for controlled release of bioactive factors|
|Abstract:||A composition and method for controlled release of water-soluble proteins comprising a surface-eroding polymer matrix and water-soluble bioactive factors is described. The composition bioerodes in the biological environment of the subject at a controlled rate, thereby releasing the water soluble proteins at a rate which allows them to interact with local cell populations.|
|Inventor(s):||Laurencin; Cato T. (Somerville, MA), Lucas; Paul A. (Macon, GA), Syftestad; Glenn T. (Sacramento, CA), Domb; Abraham (Baltimore, MD), Glowacki; Julie (Jamaica Plan, MA), Langer; Robert S. (Newton, MA)|
|Assignee:||Massachusetts Institute of Technology (Cambridge, MA)|
|Filing Date:||Aug 07, 1996|
|Claims:||1. A method of inducing chondrogenesis and osteogenesis in an animal comprising implanting in the animal a delivery device comprising: |
a. a shaped matrix sized and adapted for administration of the bioactive substance to an animal and formed of a polymer selected from the group consisting of polyanhydride and polyorthoester; and
b. a therapeutically effective amount of a bioactive substance selected from the group consisting of water soluble chondrogenic or osteogenic proteins derived from demineralized bone matrix, TGF-beta, EGF, FGF and PDGF, wherein the bioactive substance is present in an amount of between about 10 and 90 percent by weight of matrix;
wherein the composition erodes at a controlled rate over a period of time, thereby administering the bioactive substance to the animal in an amount effective to induce formation of cartilage and bone or wound healing.
2. The method of claim 1 wherein the polyanhydride is selected from the group consisting of:
poly[bis(p-carboxyphenoxy)propane anhydride], poly[bis(p-carboxy)methane anhydride] and poly[bis)p-carboxyphenoxy)propane anhydride]-sebacid acid copolymer.
3. The method of claim 1 wherein the water soluble chondrogenic or osteogenic proteins derived from demineralized bone matrix is a mixture of cold water-soluble proteins.
4. The method of claim 3 wherein the cold water-soluble proteins are proteins derived from demineralized bone matrix.
5. The method of claim 1 wherein the chondrogenic or osteogenic proteins is derived from demineralized bovine femur bone matrix.
6. The method of claim 1 wherein the bioactive substance is selected from the group consisting of TGF-beta, EGF, FGF and PDGF.
7. The method of claim 1 wherein the composition comprises a continuous matrix having a bioactive substance interspersed therethrough.
8. The method of claim 1 which is administered to release bioactive substance intramuscularly.
9. The method of claim 1 wherein
the shaped matrix sized and adapted for administration of the cartilage and bone inducing substance is formed from a polyanhydride polymer selected from the group consisting of poly(bis(p-carboxyphenoxy)propane anhydride), poly(bis(p-carboxyphenoxy)methane anhydride) and poly(bis(p-carboxyphenoxy)propane anhydride-sebacic acid); and
the cartilage and bone inducing amount of a protein preparation derived from demineralized bone matrix consists of a mixture of cold water-soluble proteins capable of inducing chondrogenesis and osteogenesis having a range of molecular weight of from about 10 to about 100 Kd.
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