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Publication Number
US-12226532-B2
Publication Date
2025-02-18
Expiration Date
Abstract
A coated biological composition has a mixture of biologic material and a volume of a liquid protectant. The mixture of biologic material has non-whole cellular components or whole cells or combinations of the non-whole cellular components and whole cells, wherein the mixture is compatible with biologic function. The volume of a liquid protectant is intermixed with the mixture of biologic material, wherein the liquid protectant forms a coating externally enveloping each of the non-whole cellular components, if any, and each of the whole cells, if any, of the mixture of biologic material, to form the coated biological composition. The coated biological composition is frozen and thereafter thawed and then frozen a second time for storage or frozen at least once and thawed and stored under refrigeration above freezing, or frozen and thawed and then concentrated by drying, or while frozen without thawing lyophilized for ambient or room temperature storage.
Core Innovation
The document describes a coated biological composition made from bone-marrow-derived non-whole cellular components and optionally whole cells obtained from a cadaver donor. The non-whole cellular components include cellular derivatives and secretome-type fractions, with non-cellular fractions collected from a density gradient, and the biological material is suspended and intermixed with a liquid protectant that forms an external coating or shroud around each component of the mixture.
The liquid protectant is described as a polyampholyte or polyampholyte cryoprotectant, including polyamine polymers such as carboxylated poly-lysine and other polyamino-polymer examples. The coated composition is produced by mechanically separating cellular and non-cellular components from vertebral bone and bone marrow, concentrating, filtering through a blood filter, performing density gradient centrifugation to establish a cell density gradient, collecting predetermined density fractions, washing, and suspending the non-cellular fractions in the liquid protectant.
The coated biological composition is then subjected to freezing at a controlled rate followed by thawing and freezing a second time prior to storage, or alternatively thawing and refrigerating, thawing and concentrating by drying, or lyophilizing the frozen coated biological composition for ambient or room temperature storage. The document attributes to this approach preserved bioactive/bioavailable regenerative potential and includes stated functional assertions related to delayed cell flattening/attachment bias, buffered early inflammation, and host-donor proximity facilitating paracrine, exosome-mediated, and genetic material exchange.
The manufacturing context described includes obtaining the cut vertebral body, grinding, tumbling and sieving to separate components from a decanted fluid, concentrating by centrifugation, and separating non-cellular fractions by density gradient centrifugation. The document also describes preparation for ambient storage via drying or lyophilization and includes stated constraints such as moisture content at 5% or less and particle size micronization limits for the dried coated composition.
Claims Coverage
The only independent claim provided is clm-00001. It covers one inventive feature set directed to making a coated biological composition by separating bone marrow cellular and non-whole components from vertebral bone, collecting predetermined density non-cellular fractions, washing, suspending the fractions in a liquid protectant to form a coated biological composition, and applying freezing/refreezing or alternate storage-preparation options including refrigeration, drying, or lyophilizing.
Coated biological composition from cadaver donor vertebral bone and bone marrow
A method of making a coated biological composition comprising grinding a cut vertebral body obtained from a cadaver donor to produce a mixture comprising crushed vertebral bone and bone marrow, mechanically separating cellular and non-cellular components of bone marrow from the vertebral bone, and concentrating and filtering to form a mixture including whole cells and non-whole cellular components.
Density gradient collection of predetermined non-cellular fractions
Separating the cellular components comprising whole cells and non-whole cellular components of the bone marrow by density gradient centrifugation to establish a cell density gradient, and collecting non-cellular fractions or non-cellular components or combinations thereof of predetermined density from the gradient.
Liquid protectant suspension to form external coating/shroud
Washing the non-cellular fractions to create a mixture, and suspending the mixture to a predetermined concentration in a liquid protectant to form the coated biological composition.
Controlled freezing followed by storage-preparation options including ambient lyophilizing
Freezing the coated biological composition at a predetermined controlled rate and thawing and freezing the coated biological composition a second time prior to storage, or alternatively thawing and refrigerating, thawing and concentrating by drying, or lyophilizing the frozen coated biological composition for ambient or room temperature storage.
Polyampholyte/polyamine polymer liquid protectant concentration range
Mixing the mixture of step (f) with a polyampholyte liquid protectant comprising a 1-50 w/w% aqueous solution of specified polyamine polymer compounds.
Moisture-limited dried coated composition
A dried coated biological composition having a moisture content of 5% or less.
Micronized dried coated particle size limit
Micronizing the dried coated biological composition into particles of 1000 microns or less.
Cryopreservation temperature range for freezing/storage
Performing cryopreservation at a temperature between 0 degrees C and -200 degrees C.
Implantation-related coating shell metabolization timing
Implanting the coated biological composition in a patient where the coating forms a shell configured to be metabolized by host cells after a predetermined time of three or more days.
Across the provided independent claim, the core inventive coverage is directed to producing a coated biological composition by separating vertebral-bone/marrow components, isolating predetermined density non-cellular fractions via density gradient centrifugation, suspending the washed non-cellular fractions in a liquid protectant to form an external coating or shroud, and using controlled freezing followed by storage-preparation options including thawing/refreezing, refrigeration, drying, or lyophilizing for ambient storage. The partial content further indicates dependent narrowing to specific polyampholyte/polyamine polymer liquid protectant concentration ranges, moisture-limited drying, micronization particle-size limits, a cryopreservation temperature range, and coating-shell metabolization timing after implantation.
Stated Advantages
Preserved bioactive/bioavailable regenerative potential.
Delayed cell flattening/attachment bias.
Buffered early inflammation.
Host-donor proximity facilitates paracrine/exosome/genetic material exchange.
Reduced need for sub-zero storage due to cryo-lyophilization.
Documented Applications
Bone allograft preparations.
Cartilage preparations.
Disc/nucleus pulposus preparations, including a disc desiccation context with micronized <400 microns powder described.
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