Purified amniotic membrane compositions and methods of use
Inventors
Tseng, Scheffer • He, Hua • Li, Wei
Assignees
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Publication Number
US-9956252-B2
Publication Date
2018-05-01
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 a composition comprising a water-soluble extract of amniotic membrane from frozen or previously frozen placenta. The water-soluble extract comprises tumor necrosis factor-stimulated gene 6 (TSG-6), pentraxin (PTX-3), thrombospondin (TSP-1), and high molecular weight hyaluronan (HA) that is cross-linked by a covalent bond to a heavy chain of inter-a-trypsin inhibitor (IαI).
The composition further includes a thickening agent and glycerin, and the amniotic membrane source includes human placenta/amniotic membrane material, including pieces, extracts, jelly, stroma and mixtures. The composition can be provided in gel or thickened forms and may also include Smad7.
The described biological context includes modulation of TGF-β signaling, including suppression of TGF-β1 promoter activity and associated signaling through TGF-β receptors and Smad signaling. The stated outcomes include reduced apoptosis and inflammation and anti-angiogenic and wound-healing effects, with characterization and validation of the components including an HA high molecular weight profile, presence of IαI and the covalent HA-IαI complex, and detection of TSG-6, PTX-3, TSP-1, and optional Smad7.
Claims Coverage
The document includes one independent claim describing a base composition with four specified bioactive components in a covalently cross-linked HA-IαI complex, plus formulation components. Dependent claims further add optional factors and refine formulation and dosage-form context.
Water-soluble amniotic membrane extract from frozen or previously frozen placenta with TSG-6, PTX-3, TSP-1, and covalently cross-linked high molecular weight HA to IαI heavy chains
A composition comprising a water-soluble extract of amniotic membrane from frozen or previously frozen placenta, wherein the water-soluble extract comprises tumor necrosis factor-stimulated gene 6 (TSG-6), pentraxin (PTX-3), thrombospondin (TSP-1), and high molecular weight hyaluronan (HA) that is cross-linked by a covalent bond to a heavy chain of inter-a-trypsin inhibitor (IαI).
Thickening agent and glycerin for the composition
The composition further includes a thickening agent and glycerin.
Optional inclusion of Smad7
The composition further includes Smad7.
Thickening agent selected from specified polymers or combinations
The thickening agent is selected from xanthan gum, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyethylene glycol, sodium carboxymethyl cellulose, or combinations thereof.
Penetration enhancer and aqueous adjuvant
The composition further includes a penetration enhancer and an aqueous adjuvant.
Multiple enumerated dosage forms
The composition can be formulated in various dosage forms, including solution, drops, suspension, aerosol, paste, spray, ointment, oil, emulsion, cream, lotion, gel, a coated bandage, a patch, sticks, balms, or shampoo.
Wound dressing with backing material
A wound dressing is provided that includes the composition of claim 1 together with a backing material.
Overall, the claim coverage centers on a water-soluble extract of amniotic membrane from frozen or previously frozen placenta containing TSG-6, PTX-3, TSP-1, and high molecular weight HA covalently cross-linked to an IαI heavy chain, combined with a thickening agent and glycerin. Dependent claims then optionally add Smad7 and refine the formulation by selecting specific thickening agents, adding a penetration enhancer and aqueous adjuvant, enumerating dosage forms, and extending the composition to a wound dressing with a backing material.
Stated Advantages
Stated modulation of TGF-β signaling, including suppression of TGF-β1 promoter activity and effects associated with TGF-β receptor/Smad signaling.
Reduced apoptosis.
Reduced inflammation.
Anti-angiogenic and wound-healing effects.
Documented Applications
Topical and other formulation contexts using the claimed composition in gel or thickened forms, including skin lotion formulations.
Ophthalmic use, including ophthalmic solutions and ophthalmic ointments/eye drops.
Wound dressing use, including a wound dressing that includes the composition with a backing material.
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