Patent 5328695 Issued on July 12, 1994. Estimated Expiration Date: February 11, 2012. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
A myogenic protein isolate from mammalian bone is provided that stimulates lineage commitment and differentiation of stem cells in vitro and in vivo. The protein isolate is characterized by its ability to cause muscle stem cell differentiation without excessive proliferation of connective tissue proximal to the delivery site. Treated muscle stem cells differentiate into myotubes and multinucleated structures with minimal formation of scar tissue, resulting in functional muscle tissue restoration in vivo, and therefore useful in the treatment of a number of disorders and injuries. The protein isolate is preferably administered by implanting a bioerodible polymer matrix, preferably a surface erodible polymer such as a polyanhydride or a polyorthoester, interspersed with the protein isolate near the site of muscle injury or degeneration, but can be administered directly to cells cultured in vitro.
Other References
Carlson, B. M. and J. A. Faulkner, "The regeneration of skeletal muscle fibers following injury: a review," 15(3) Med. Sci. Sports & Exercise 187-198 (1983)
Buckley, A., et al., "Sustained release of epidermal growth factor accelerates wound repair," 82 Proc. Natl. Acad. Sci. USA 7340-7344 (Nov. 1985)
Davidson, J., et al. "Mechanisms of accelerated wound repair using epidermal growth factor and basic fibroblast growth factor," Proc. Second Intern'l Symp. on Tissue Repair, in Growth factors and other aspects of wound healing: Biological and clinical implications, A. Barbul et al., eds., Alan R. Liss, New York, pp. 63-75 (1988)
Donovan, C. M., and J. A. Faulkner, "Plasticity of skeletal muscle: regenerating fibers adapt more rapidly then surviving fibers," 62(4-6) J. App. Phys. 1345-2543 (1987)
Ewton, D. Z., and J. R. Florini, "Effects of insulin-like growth factors and transforming growth factor-beta on the growth and differentiation of muscle cells in culture," 194(2) Proc. Soc. Exp. Biol. Med. 76-80 (Jun. 1990)
Ewton, D. Z., and J. R. Florini, "Effects of the somatomedins and insulin on myoblast differentiation in vitro", 86 Dey. Biol. 31-39 (1981)
Faulkner, J. A. and B. M. Carlson, "Skeletal muscle regeneration: a historical perspective," 45(5) Fed. Proc. 1454-1455 (Apr. 1986)
Florini, J. R., et al., "Transforming growth factor-ଲ: A very potent inhibitor of myoblast differentiation, identical to the differentiation inhibitor secreted by buffalo rat liver cells," 261 J. Biol. Chem. 16509-16513 (Dec. 15, 1986)
Florini, J. R., et al., "Biphasic concentraton dependency of stimulation of myoblast differentiation by somatomedins," 250(15) Amer. J. Physiol. C771-C778 (May 1986)
Franklin, T. J., et al., "Acceleration of wound healing by recombinant human urogastrone (epidermal growth factor)," 108(2) J. Lab. Clin. Med. 103-108 (Aug. 1986)
Grotendorst, G. R., et al., "Stimulation of granulation tissue formation by platelet-derived growth factor in normal and diabetic rats", 76 J. Clin. Invest. 2323-2329 (Dec. 1985)
Lim, R. W., and S. D. Hauschka, "A rapid decrease in epidermal growth factor-binding capacity accompanies the terminal differentiation of mouse myoblasts in vitro," 98 J. Cell Biol. 739-747 (1984)
Linkhart, T. A., et al., "Control of mouse myoblast commitment to terminal differentiation by mitogens," in Muscle Development: Molecular and Cellular Control, M. L. Pearson and H. F. Epstein, eds., Cold Spring Harbor Laboratory, New York, pp. 377-382 (1982)
Linkhart, T. A., et al., "Myogenic differentiation in permanent clonal mouse myoblast cell lines: Regulation by macromolecular growth factors in the culture medium," 86 Dev. Biol. 19-30 (1981)
Mustoe, T. A., et al., "Accelerated healing of incisional wounds in rats induced by transforming growth factor-beta," 237 Science 1333-1336 (Sep. 11, 1987)
Olwin, B. B., and S. D. Hauschkla, "Identification of the fibroblast growth factor receptor os Swiss 3T3 cells and mouse skeletal muscle myoblasts," 25(12) Biochemistry 3487-3492 (Jun. 17, 1986)
Reddi, A. H., and C. Huggins, "Biochemical sequences in the transformation of normal fibroblsts in adolescent rats," 69 Proc. Nat. Acad. Sci. USA 1601-1605 (Jun. 1972)
Roberts, A. B., et al., "Transforming growth factor type ଲ: Rapid induction of fibrosis and angiogenesis in vivo and stimulation of collagen formation in vitro," 83(11) Proc. Natl. Acad. Sci. USA 4167-4171 (Jun. 1986)
Sejersen, T., et al., "Rat skeletal myoblasts and arterial smooth muscle cells express the gene for the A chain but not the gene for the B chain (c-sis) of platelet-derived factor (PDGF) and produce a PDGF-like protein," 83 Proc. Natl. Acad. Sci. USA 6844-6848 (Sep. 1986)
Sprugel, K. H., et al., "Effects of growth factors in vivo, I. Cell ingrowth into porous subcutaneous chambers," 129(3) Amer. J. Pathol. 601-613 (Dec. 1987)
Urist, M. R., et al., "Osteogenetic competence," 64 Clin Orthopaed. Rel. Res. 194-220 (May-Jun. 1969)
Urist, M. R., "Bone: Formation by autoinduction," 150 Science 893-899 (Nov. 12, 1965)
Young, H. E., et al., "Glycoconjugates in normal wound tissue matrices during the initiation phase of limb regeneration in adult Ambystoma," 223 Anat. Rec. 231-241 (1989)
Bader, D., et al., "Immunochemical analysis of myosin heavy chain during avian myogenesis in vivo and in vitro," 95 J. Cell Biol. 763-770 (Dec. 1982)
Bischoff, R., "Proliferation of muscle satellite cells on intact myofibers in culture," 115 Dev. Biol. 129-139 (1986)
Bischoff, R., "A satellite cell mitogen from crushed adult muscle," 115 Dev. Biol. 140-147 (1986)
Bischoff, R., "Tissue culture studies on the origin of myogenic cells during muscle regeneration in the rat," pp. 13-29, in Muscle Regeneration, A. Mauro et al., ed., Raven Press, New York (1979)
Carlson, B. M., "The regeneration of skeletal muscle-A review," 137 Am. J. Anat. 119-150 (May-Jul. 1979)
Schultz, E., et al., "Response of satellite cells to focal skeletal muscle injury," 8 Mucscle and Nerve 217-222 (Mar.-Apr. 1985)
Schultz, E., "A quantitative study of satellite cells in regenerated soleus and extensor digitorum longus muscles," 208 Anat. Rec. 501-506 (Jan.-Apr. 1984)
Snow, M. H., "Myogenic cell formation in regenerating rat skeletal muscle injured by mincing: A fine structural study," 188(2) Anat. Rec. 181-199 (Jun. 1977)
Snow, M. H., "Myogenic cell formation in regeneration rat skeletal muscle injured by mincing: An autoradiographic study," 188 Anat. Rec. 210-217 (May-Aug. 1977)
Young, H. E., et al., "Cryopreservation of embryonic chick myogenic lineage-committed stem cells," 13 J. Tiss. Cult. Meth. 275-288 (1991)
Young, H. E., et al., "Comparison of fixatives for maximal retention of radiolabeled glycoconjugates for autoradiography, including use of sodium sulfate to release unicorporated [36 ]-sulfate," 37(2) J. Histochem. Cytochem. 223-228 (1989)
Young, H. E., et al., "Initial characterization of small proteoglycans synthesized by embryonic chick leg muscle-associated connective tissues," 17 Connec. Tiss. Res. 99-118 (1989)
Young, H. E., et al., "Histochemical analyusis of newly synthesized and accumulated sulfated glycosaminoglycans during musculogenesis in the embryonic chick leg," 201 J. Morph. 85-103 (1989)
Young, H. E., et al., "Histological analysis of limb regeneration in postmetamorphic adult Ambystoma," 212 Anat. Rec. 183-194 (1985)
Florini, J. R., et al., "Hormones, growth factors, and myogenic differentiation," 53 Ann. Rev. Physiol. 201-216 (1991
February 11, 2012. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
