Viable disc regenerative composition and method of manufacture and use
Inventors
Temple, Harry Thomas • Ganey, Timothy • Gonzalez, Stephanie • Anderson, Tracy Scott • Namin, Shabnam
Assignees
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Publication Number
US-11324215-B2
Publication Date
2022-05-10
Expiration Date
Abstract
A viable disc regenerative composition has a micronized material of nucleus pulposus and a biological composition made from a mixture of mechanically selected allogeneic biologic material derived from bone marrow having non-whole cellular components including vesicular components and active and inactive components of biological activity, cell fragments, cellular excretions, cellular derivatives, and extracellular components; and wherein the mixture is compatible with biologic function and further includes non-expanded whole cells. The biological composition is predisposed to demonstrate or support elaboration of active volume or spatial geometry consistent in morphology with that of disc tissue. The viable disc regenerative composition extends regenerative resonance that compliments or mimics disc tissue complexity.
Core Innovation
The invention provides a viable disc regenerative composition comprising micronized nucleus pulposus having particles in a size range of less than 300 μm combined with a bone-marrow-derived allogeneic biological mixture. The bone-marrow-derived biological mixture includes cellular and non-cellular components, including non-whole cellular components such as vesicles, cell fragments, cellular excretions, cellular derivatives, and extracellular components, together with optionally non-expanded whole cells including MIAMI cells. The composition is described as mimicking disc tissue morphology and supporting regenerative “resonance.”
The micronized nucleus pulposus is rehydrated to form a high-viscosity, flowable, injectable material for delivery into a damaged disc. The document describes the rehydrated micronized nucleus pulposus combined with the frozen bone-marrow-derived mixture as packaged material, and the composition is described for delivery into a damaged disc using a small cannula, with optional sealing with fibrin glue.
The document also describes manufacturing and preservation concepts for creating the viable composition. Bone marrow is collected, recovered, and processed from a cadaver donor, then processed to form a cryopreserved mixture by separating cellular and non-cellular components using mechanical separation, centrifugation and filtration, and density gradient separation. The separated components are suspended in a polyampholyte cryoprotectant and frozen at a predetermined controlled rate, then packaged combined with the micronized nucleus pulposus prepared by freeze-drying and cryogenic micronization.
Claims Coverage
The provided excerpt includes two independent claims. Across these independent claims, the inventive features focus on processing bone marrow from a cadaver donor into cellular and non-cellular components, cryopreserving those components in a polyampholyte cryoprotectant with controlled-rate freezing, combining the resulting frozen mixture with micronized nucleus pulposus particles sized to less than 300 μm, and, in the second independent claim, removing whole cells to reach a cell concentration of zero.
Controlled cryopreservation of bone-marrow cellular and non-cellular components in a polyampholyte cryoprotectant
A method that collects, recovers and processes bone marrow from a cadaver donor, mechanically separates cellular and non-cellular components, concentrates by centrifugation and filtering, separates by density gradient, washes to create a washed mixture, quantifies cell concentration, suspends the cellular components with whole cells and non-cellular components in a polyampholyte cryoprotectant to form a cryopreserved mixture, and freezes the cryopreserved mixture to produce a frozen mixture at a predetermined controlled rate.
Combination with micronized nucleus pulposus packaged together with the cryopreserved bone-marrow mixture
The method combines the frozen mixture with micronized nucleus pulposus having particles in the size range of less than 300 μm and packages the frozen mixture combined with micronized nucleus pulposus.
Removal of whole cells to achieve cell concentration zero before cryopreservation
A method that removes the whole cells from the washed mixture to create a cell concentration of zero, suspends the cellular components with non-cellular components of bone marrow or combinations thereof to a predetermined concentration in a polyampholyte cryoprotectant to form a cryopreserved mixture, freezes it at a predetermined controlled rate, and combines it with micronized nucleus pulposus particles sized to be less than 300 μm before packaging.
Together, the independent claims cover making a viable disc regenerative composition by processing bone marrow from a cadaver donor into cellular and non-cellular components, cryopreserving them in a polyampholyte cryoprotectant with controlled-rate freezing, optionally removing whole cells to reach cell concentration zero, and combining the resulting frozen mixture with micronized nucleus pulposus particles smaller than 300 μm for packaging.
Stated Advantages
Supports regenerative “resonance” and mimics disc tissue morphology.
Described as forming a high-viscosity, flowable, injectable material for delivery into a damaged disc.
Thawed mixture shows reported cell viability at 6 months post-thaw and reported percent recovery at 6 months.
Documented Applications
A treatment method for regenerating a damaged viable disc by rehydrating micronized material into a flowable mixture and injecting the hydrated material via a cannula into the disc space to be regenerated.
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