Amniotic membrane preparations and purified compositions and therapy for scar reversal and inhibition
Inventors
Tseng, Scheffer • He, Hua • Li, Wei
Assignees
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Publication Number
US-9161955-B2
Publication Date
2015-10-20
Expiration Date
Abstract
Compositions having a combination of specific biological components have been found to exert a number of useful effects in mammalian cells, including modulating TGF β signaling, apoptosis, and proliferation of mammalian cells, as well as decreasing inflammation in mice. These components can be obtained commercially, or can be prepared from biological tissues such as placental tissues. Placental amniotic membrane (AM) preparations described herein include AM pieces, AM extracts, AM jelly, AM stroma, and mixtures of these compositions with additional components. The compositions can be used to treat various diseases, such as wound healing, inflammation and angiogenesis-related diseases.
Core Innovation
The invention provides purified amniotic membrane preparations and compositions for inhibiting or reversing scar formation by modulating mammalian cell physiology. The disclosed activity is associated with suppressing TGF-β signaling, reducing inflammation, and decreasing apoptosis of injured cells, including vascular endothelial cell apoptosis and macrophage apoptosis.
The disclosed scar-directed modulation includes effects on myofibroblast phenotype, including reduction of α-SMA and preventing or reversing myofibroblast phenotypes. The disclosure also describes inhibition of fibroblast migration and de-differentiation of myofibroblasts, including de-differentiation without proliferation.
Purified AM-derived components are described as including cross-linked high-molecular-weight hyaluronan, TSG-6, PTX-3, and TSP-1, with optionally Smad7. The invention also describes AM preparations derived from frozen or previously frozen placental material and AM formats such as extract, gel, jelly, stroma, liquid, ground or pulverized, and lyophilized powder.
Claims Coverage
The independent claims cover two core claim approaches centered on scar formation inhibition or reversal. Across the independent claims, the coverage includes at least four inventive elements involving frozen or previously frozen placental material, ground or pulverized amniotic membrane, and composition-level framing for administration.
Ground or pulverized frozen placental amniotic membrane for scar inhibition or reversal
Administering a ground or pulverized amniotic membrane derived from a frozen or previously frozen placental material to inhibit or reverse scar formation in an individual in need thereof.
Composition comprising ground or pulverized frozen placental amniotic membrane
Administering a composition comprising a ground or pulverized amniotic membrane derived from a frozen or previously frozen placental material to inhibit or reverse scar formation in an individual in need thereof.
Taken together, the independent claims provide coverage for inhibiting or reversing scar formation by administering ground or pulverized amniotic membrane prepared from frozen or previously frozen placental material, with one claim directed to direct administration of the membrane and the other directed to administration of a composition comprising that membrane.
Stated Advantages
Inhibiting or reversing scar formation.
Suppressing TGF-β signaling and reducing inflammation.
Decreasing apoptosis of injured cells.
Inhibiting fibroblast migration.
Promoting de-differentiation of myofibroblasts.
Documented Applications
Treatment of eye burns (topical and ophthalmic formulations are described).
Scar inhibition or reversal in skin using topical lotions/creams.
Rectal gel use as an application for the described therapy.
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