Acellular biologic composition and method of manufacture
Inventors
Ganey, Timothy • Weston, Wendy W. • Delcroix, Gaëtan Jean-Robert
Assignees
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Publication Number
US-12048719-B2
Publication Date
2024-07-30
Expiration Date
Abstract
A biological composition has a mixture of mechanically selected allogeneic biologic material derived from placental tissue. The mixture has non-whole cellular components including vesicular components and active and inactive components of biological activity, cell fragments, cellular excretions, cellular derivatives, and extracellular components. The mixture including non-whole cell fractions including one or more of exosomes, transcriptosomes, proteasomes, membrane rafts, lipid rafts. The mixture is compatible with biologic function.
Core Innovation
The invention relates to an implantable cryopreserved acellular biological composition consisting of an acellular mixture of non-whole cellular placental tissue derived from amnion, chorion, umbilical cord, and liquid placental tissue components of mechanically selected biologic material derived and separated from placental tissue. Whole cells are removed from the placental tissue by density gradient centrifugation to form the acellular mixture, which includes vesicular components, active and inactive components of biological activity, cell fragments including organelle fragments, non-whole cell fractions, and extracellular components.
The non-whole cell fractions include one or more of exosomes, transcriptosomes, proteasomes, membrane rafts, lipid rafts, cellular excretions, cellular derivatives, and extracellular components that include matrices, membranes, particles, and non-cellular materials derived from the placental tissue. The acellular mixture is compatible with biologic function to support new tissue formed independent of mesenchymal cells.
A volume of polyampholyte cryoprotectant is configured for direct implantation and is added to the acellular mixture prior to freezing and cryopreservation, thereby forming a suspension of the acellular mixture to a predetermined concentration in the cryoprotectant. The suspension is frozen for cryopreservation, creating a frozen cryopreserved composition configured to be thawed at the time of use.
Claims Coverage
The independent claim set includes one independent claim that specifies an implantable cryopreserved acellular biological composition and its incorporation with a polyampholyte cryoprotectant for direct implantation and thawing at use. The independent claim emphasizes mechanically selected placental-derived non-whole cellular fractions and removal of whole cells, followed by cryopreservation via a polyampholyte suspension.
Acellular placental mixture of non-whole cellular components
An implantable cryopreserved acellular biological composition consisting of an acellular mixture of non-whole cellular placental tissue derived from amnion, chorion, umbilical cord, and liquid placental tissue components of mechanically selected biologic material, wherein whole cells have been removed from the placental tissue by density gradient centrifugation to form the acellular mixture, and wherein the acellular mixture includes vesicular components, active and inactive components of biological activity, cell fragments including organelle fragments, non-whole cell fractions, and extracellular components including matrices, membranes, particles, and non-cellular materials.
Non-whole cell fractions including exosomes and related components
The acellular mixture is characterized such that one or more non-whole cell fractions include one or more of exosomes, transcriptosomes, proteasomes, membrane rafts, lipid rafts, cellular excretions, and cellular derivatives.
Compatibility for new tissue formed independent of mesenchymal cells
The acellular mixture is compatible with biologic function to support new tissue formed independent of mesenchymal cells.
Polyampholyte cryoprotectant suspension for direct implantation and thawing at use
A volume of polyampholyte cryoprotectant configured for direct implantation is added to the acellular mixture prior to freezing and cryopreservation, thereby forming a suspension of the acellular mixture to a predetermined concentration in the cryoprotectant, wherein the suspension of the acellular mixture is frozen for cryopreservation to create a frozen cryopreserved composition configured to be thawed at the time of use.
Across the independent claim, the inventive subject matter is an implantable cryopreserved acellular composition prepared by removing whole cells from mechanically selected placental-derived material via density gradient centrifugation, providing an acellular mixture of vesicular and extracellular/non-cellular fractions including exosomes and related non-whole cell fractions, ensuring compatibility for new tissue formation independent of mesenchymal cells, and cryopreserving the mixture as a polyampholyte cryoprotectant suspension configured for direct implantation and thawing at use.
Stated Advantages
Supports new tissue formed independent of mesenchymal cells.
Documented Applications
No documented applications found
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