There has been many patents over the years that were filed by large and mid sized Biotech and Biomedical companies trying to protect their ideas and methods on how to regrow bones. This idea of using the TGF-Beta has been a very common and well understood concept. I list a few patents I have found from Google Patent which show exactly what concentrations of TGF-Beta would be needed to be injected into the human leg to cause bone growth in vivo. However this would not make the bone actually longer, but only make the bone mineral density increase.
Patent #1: Method of inducing bone growth using TGF-β – US 5158934 A
Abstract: A method is provided for generation of bone at a site of an animal where skeletal tissue is deficient comprising administering to the animal, locally at the bone site in the presence of a source of osteogenic cells, an effective amount of a composition comprising TGF-β in a pharmaceutically acceptable carrier, provided that such composition excludes a bone morphogenetic cofactor, the composition being administered in an amount effective to induce bone growth at the bone site. Also provided is a device for implantation into a site of an animal where skeletal tissue is deficient comprising a device treated with an effective amount of a composition comprising TGF-β and a source of osteogenic cells in a pharmaceutically acceptable carrier.
What is claimed is: A method for generation of bone at a site of an animal where skeletal tissue is deficient comprising administering to the animal, locally at the site in the presence of an osteogenic cell source, an effective amount of a composition consisting essentially of TGF-β in a pharmaceutically acceptable carrier, provided that such composition excludes a bone morphogenetic cofactor, the composition being administered to the animal in an amount effective to induce growth of morphologically normal, mature bone at the site.
Patent #2: TGF-β composition for inducing bone growth – US 5409896 A
Abstract: A method is provided for generation of bone at a site of an animal where skeletal tissue is deficient comprising administering to the animal, locally at the bone site in the presence of a source of osteogenic cells, an effective amount of a composition comprising TGF-β in a pharmaceutically acceptable carrier, provided that such composition excludes a bone morphogenetic cofactor, the composition being administered in an amount effective to induce bone growth at the bone site. Also provided is a device for implantation into a site of an animal where skeletal tissue is deficient comprising a device treated with an effective amount of a composition comprising TGF-β and a source of osteogenic cells in a pharmaceutically acceptable carrier.
What is claimed is:
1. A pharmaceutical composition for treatment of a site of an animal where skeletal tissue is deficient consisting essentially of about 1 to 100 ng/ml of TGF-β and an osteogenic cell source isolated from an animal, which composition is formulated in a pharmaceutically acceptable carrier and excludes a bone morphogenetic cofactor.
2. The composition of claim 1 wherein the osteogenic cell source is dispersed whole bone marrow, perichondrium, periosteum, or a cell line.
3. The composition of claim 1 wherein the TGF-β is TGF-β1 or TGF-β3.
Patent #3: TGF-β formulation for inducing bone growth – US 5422340 A
Abstract: A formulation suitable for inducing bone formation contains about 0.5 μg to about 5 mg of transforming growth factor-β and about 140 mg to about 50 g of tricalcium phosphate and excludes a bone morphogenetic cofactor. In another embodiment, the formulation contains about 0.5 μg to 5 mg transforming growth factor-β, about 140 mg to 50 g of tricalcium phosphate particles, and an amount of amylopectin ranging from about 01:1 to 1:1 amylopectin:tricalcium phosphate.
Field of the Invention: This invention relates to the use of transforming growth factor-beta (TGF-β) to induce bone growth in vivo and to formulations of TGF-β and tricalcium phosphate useful for this purpose.
What is claimed is: A bone-inducing formulation consisting essentially of about 0.5 μg to about 5 mg of transforming growth factor-β and about 140 mg to about 50 g of tricalcium phosphate.
2. The formulation of claim 1 wherein the tricalcium phosphate is particles.
3. The formulation of claim 2 wherein the particles are granules or a powder.
4. The formulation of claim 3 wherein the transforming growth factor-β is adsorbed on the granules or powder.
5. The formulation of claim 3 wherein the tricalcium phosphate is in the form of granules with a diameter of about 120 to 500 μm.
6. The formulation of claim 1 further comprising a polymer selected from amylopectin, gelatin, collagen, agarose, or a mixture of these polymers, in an amount effective to enhance consistency of the formulation.
7. The formulation of claim 6 wherein the polymer is lyophilized before use.
Analysis On The Patents:
The first two patents are essentially the same one, since the patent inventors are the same people and they are from the same company, Genentch back in the mid 1990s. The Abstract or Introduction are the same thing. However there is just a slight change to the patents, which are separated by 2 years of patent filing. It seems that from the first two patents, there is 5 main parts to the patent…
- A device used for implantation, like a syringe or something,
- The TGF-Beta composition, which will have TGF-Beta1 and TGF-Beta3 (concentration is 1- 100 ng/mL of TGF-beta)
- A carrier, probably like a gel or scaffold which the TGF-Beta will go into.
- A source of osteogenic cells – which is probably explanted out first.
- Excludes a bone morphogenetic cofactor.
These 3 parts (osteogenic cell source with TGF-Beta composition with the carrier) are combined and the device takes the mixture and puts it into an area of the human bone where there is no bone growth or bone. The mixture will cause bones to grow in the bone defect area. However that will not be enough to create the cartilage we need which will expand and grow out.
The third patent is very similar in its area of focus. The patent inventor is the same person. This time the TGF-Beta is used at a higher concetration, around 0.5 micrograms to 5 miligrams. There is a type of tricalcium phosphate which is in a granular, powder form. The TGF-Beta is absorbed into the granular powder and this mixture is added into bone defects to induce bone matrix formation. This patent also is excluding a certain bone morphogenetic cofactor. There is something called amylopectin which is used to make a polymer selected from amylopectin, gelatin, collagen, agarose, or a mixture of these polymers, in an amount effective to enhance consistency of the formulation.
