Compositions of morselized umbilical cord and/or amniotic membrane and methods of use thereof
Inventors
Tseng, Scheffer • Chua, Lorraine
Assignees
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Publication Number
US-11116800-B2
Publication Date
2021-09-14
Expiration Date
Abstract
The invention relates generally to the fields of biology and life sciences. More particularly, the invention relates to compositions and methods for modulating cellular physiology and pathological processing using a combination of compounds that can be found in morselized amniotic membrane tissue and morselized umbilical cord tissue preparations.
Core Innovation
The invention relates to gel compositions comprising a therapeutically effective amount of morselized placental amniotic membrane and a therapeutically effective amount of morselized umbilical cord, together with a pharmaceutically-acceptable excipient. Water is not substantially removed from the morselized amniotic membrane or from the morselized umbilical cord, and the morselized placental amniotic membrane and the morselized umbilical cord have a specified particle size from about 0.3 mm to about 1 cm in length, width, and thickness.
The compositions are positioned to suppress TGF-β signaling and to alter cellular physiology and pathological processing. The invention further describes the compositions as modulating macrophage apoptosis and vascular endothelial cell apoptosis, while inhibiting vascular endothelial cell proliferation and migration and reducing fibroblast viability and inflammation.
The compositions are also described as protecting epithelial cells from apoptosis. The invention additionally describes preparation and format concepts for the morselized tissues and related apparatus concepts, including forms such as wet, partially dehydrated, or lyophilized material, and optional sterilization by gamma (γ) radiation.
Claims Coverage
Independent claim clm-00001 covers a gel composition defined by therapeutically effective amounts of morselized placental amniotic membrane and morselized umbilical cord, a pharmaceutically-acceptable excipient, water not substantially removed, and a particle size range of about 0.3 mm to about 1 cm. The claim family further refines these concepts with biological activity preservation, gamma sterilization, water content, and chorion content.
Therapeutically effective gel with morselized amniotic membrane and umbilical cord
A gel composition comprising a therapeutically effective amount of morselized placental amniotic membrane and a therapeutically effective amount of morselized umbilical cord, and a pharmaceutically-acceptable excipient.
Water not substantially removed from morselized tissues
The gel composition wherein water has not been substantially removed from the morselized amniotic membrane or from the morselized umbilical cord.
Specified particle size range for morselized tissues
The gel composition wherein the morselized placental amniotic membrane and the morselized umbilical cord have a particle size from about 0.3 mm to about 1 cm in length, width, and thickness.
Substantially preserved biological activity for at least 15 days
The gel composition including morselized placental amniotic membrane and morselized umbilical cord in which their biological activity is substantially preserved for at least 15 days after initial procurement.
Gamma-sterilized gel composition
The gel composition is sterilized using gamma (γ) radiation.
Water content greater than 20% by weight
The gel composition having a water content greater than 20% by weight percentage.
Substantially free of chorion
The gel composition wherein the morselized placental amniotic membrane is substantially free of chorion.
The claim coverage centers on a gel composition containing therapeutically effective amounts of morselized placental amniotic membrane and morselized umbilical cord with a pharmaceutically-acceptable excipient, while keeping water not substantially removed and limiting tissue particle size to about 0.3 mm to about 1 cm. The disclosed refinements further specify biological activity preservation for at least 15 days, gamma sterilization, water-content thresholds, and chorion substantially free status.
Stated Advantages
Suppresses TGF-β signaling.
Alters macrophage apoptosis.
Decreases vascular endothelial cell apoptosis and inhibits vascular endothelial cell proliferation and migration.
Decreases fibroblast viability and inflammation.
Protects epithelial cells from apoptosis.
Documented Applications
Wound care and skin ulcer repair.
Ocular wound repair.
Nerve/spinal repair.
Psoriasis and arthritis.
Dermal filler.
Cardiac repair contexts [as explicitly described].
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