Fetal skin cell protein compositions for the treatment of skin conditions, disorders or diseases and methods of making and using the same
The present invention provides methods and compositions designed for treating a subject suffering from skin conditions, disorders or diseases. The compositions include fetal skin cell proteins obtained from fetal skin cells after induced cell lysis.
1. A method of treating a subject suffering from vulvodynia comprising administering to the subject a composition comprising an effective amount of a lysate of human fetal fibroblasts of 12-16 week gestation and an acceptable carrier, wherein said lysate comprises one or more fetal fibroblast proteins incorporated in said composition at a concentration of between 0.001% to 95% by volume or weight, wherein said human fetal fibroblasts are obtained from a single human organ donation of undifferentiated fetal skin cells and wherein said human donor tissue is of 12-16 weeks of gestation.
2. The method of claim 1 , wherein said one or more fetal fibroblasts are obtained from whole fetal skin tissue or fetal skin tissue fragments.
3. The method of claim 1 , wherein said one or more fetal fibroblasts are immortalized.
4. The method of claim 1 , wherein said one or more fetal fibroblasts are obtained from a cell bank or a cell line.
5. The method of claim 1 , wherein said one or more fetal fibroblast proteins are purified.
6. The method of claim 1 , wherein said lysate comprises one or more cellular components.
7. The method of claim 1 , wherein said one or more fetal fibroblast proteins comprise one or more cytokines, enzymes, hormones, extracellular matrix structural proteins, neuropeptides or neuropeptide antagonists.
8. The method of claim 7 , wherein said cytokines comprise growth factors, interleukins, lymphokines, monokines, interferons, colony stimulating factors or chemokines or combinations and mixtures thereof.
9. The method of claim 1 , wherein said composition further comprises analgesics, anesthetics, anti-inflammatory agents, antihistamine agents, antioxidants, counter irritants, antimicrobial agents, antibacterial agents, antifungal agents, preservatives, protein stabilizing agents, protease inhibitors, skin protectant agents, sunscreens or combinations and mixtures thereof.
10. The method of claim 1 , wherein said composition further comprises corticosteroids, estrogen, progesterone, lidocaine, pramoxine hydrochloride, capsaicin, isotretinoin, interferon-α, interferon-β, interferon-γ, dapsone, acyclovir, tricyclic anti-depressants, or combinations or mixtures thereof.
11. The method of claim 1 , wherein said composition is suitable for topical, mucosal, or vaginal administration.
12. The method of claim 1 , wherein said composition is an ointment, lotion, cream, foam, mousse, spray, aerosol, emulsion, nanoemulsion, mask, microemulsion, gel, hydrogel, solution, sponge or dispersion.
13. The method of claim 1 , wherein said composition is a water-in-oil or oil-in-water emulsion or the composition is a water-in-oil or oil-in-water emulsion based cream.
14. The method of claim 1 , wherein said one or more fetal fibroblast proteins are incorporated in said composition at a concentration of between 0.01% to 5%, by volume or weight.
15. The method of claim 14 , wherein said one or more fetal fibroblast proteins are incorporated in said composition at a concentration of between 0.05% to 0.25%, by volume or weight.
16. The method of claim 1 , wherein said cell lysis is induced and is not spontaneous.
17. The method of claim 1 , wherein said cell lysis is performed mechanically, physically or chemically or performed by one or more cycles of freeze-thawing.
18. The method of claim 1 , wherein said cell lysis is performed with between 100 to 60,000,000 of fetal fibroblasts suspended in one milliliter of an aqueous system.
19. The method of claim 18 , wherein said cell lysis is performed with between 10,000,000 to 20,000,000 of fetal fibroblasts suspended in one milliliter of an aqueous system.
20. The method of claim 18 , wherein said aqueous system is a physiological buffer system or a phosphate buffered saline system.
21. The method of claim 18 , wherein said aqueous system further comprises one or more protein stabilizing chemicals, protease inhibitors, anti-microbial agents, anti-bacterial agents, antioxidants, preservatives or combinations and mixtures thereof.
22. The method of claim 1 , wherein said vulvodynia is vulvar vestibulitis or vulvar vestibuliits syndrome.
23. The method of claim 1 , wherein the treatment of vulvodynia further comprises administering corticosteroids, estrogen, progesterone, lidocaine, pramoxine hydrochloride, capsaicin, isotretinoin, interferon-α, interferon-β, interferon-γ, dapsone, acyclovir, tricyclic anti-depressants or combinations or mixtures thereof.