Amniotic membrane preparations and purified compositions and therapy for scar reversal and inhibition

Inventors

Tseng, Scheffer • He, Hua • Li, Wei

Assignees

BioTissue Holdings Inc

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 relates to purified amniotic membrane preparations and compositions derived from frozen or previously frozen placental material. The preparations include ground or pulverized amniotic membrane forms and optionally other amniotic membrane components such as amniotic jelly and amniotic stroma, including AM extracts and ground/pulverized forms. The disclosed compositions are positioned for promoting wound healing and modulating cellular physiology in tissue injury and storage-related contexts.

A core multi-component activity profile is described, comprising cross-linked hyaluronan/HA, Tumor necrosis factor-stimulated gene 6 (TSG-6), Pentraxin 3 (PTX-3), and Thrombospondin-1 (TSP-1), optionally including Smad7. This activity profile is disclosed as suppressing TGF-β signaling, including TGF-β1 promoter activity and/or TGF-βRII promoter activity, thereby affecting cellular responses that include inhibition of apoptosis, reduction of inflammation, and modulation of injury-related cellular behavior.

The disclosure further states that these amniotic membrane-derived compositions prevent or reverse scar formation. The effects are described in relation to myofibroblast differentiation, including effects associated with α-SMA and ED-A fibronectin, and effects on fibroblast migration. The described biological outcomes align with broader therapeutic aims including wound healing, inflammation, angiogenesis-related diseases, and scar inhibition or scar reversal in ocular and skin disorders.

Claims Coverage

The independent claim set in the provided material identifies one independent claim. Across the dependent claims listed, multiple inventive features are refined around the use of ground or pulverized amniotic membrane from frozen or previously frozen placental material, including specific physical form, optional composition additives, optional source species limitations, and expanded formulation/route and dosage format constraints. Overall, the claim coverage centers on administering an AM-based wound-healing composition with defined preparation origin (frozen placenta) and AM physical preparation (ground/pulverized), optionally in selected formulations and routes.

The claim coverage, based on the provided independent claim and listed dependent refinements, is directed to promoting wound healing through administration of a composition containing ground or pulverized amniotic membrane isolated from frozen or previously frozen placental material. Coverage further refines the AM component physical form (dry powder), optional source species (human, bovine, or porcine), optional co-components (collagen, fibrin, hyaluronic acid), and formulation constraints (ophthalmic/systemic/topical and enumerated dosage forms and application formats).

Stated Advantages

Documented Applications