Biologic composition and method of manufacture
Inventors
Ganey, Timothy • Weston, Wendy W. • Quevedo, Miguel • Oglesby, Stuart • Delcroix, Gaetan Jean-Robert • Schiller, Paul C. • D'Ippolito, Gianluca
Assignees
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Publication Number
US-11649439-B2
Publication Date
2023-05-16
Expiration Date
Abstract
A biological composition has a mixture of mechanically selected allogeneic biologic material derived from bone marrow. 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 is compatible with biologic function.
Core Innovation
The invention relates to a tissue-regenerative allogeneic bone-marrow-derived biological composition prepared from cadaver donor material. The composition includes mechanically selected non-whole cellular components separated from cadaverous bone and optionally includes a select number of non-expanded whole cells, where the non-whole cellular components include vesicular components and cellular fragments, cellular excretions, cellular derivatives, and extracellular components.
The invention is directed to preparing and freezing an allogeneic biological composition suitable for direct implantation in a subject without washing or rinsing. The composition is created by mechanically separating cellular and non-cellular components of the bone marrow from cortical and cancellous bone, concentrating and filtering the separated mixture, and separating the mixture by density gradient centrifugation to form an interface from which cells or non-cellular components, or combinations thereof, are collected.
After collection, the invention includes washing the collected cells or non-cellular components using DPBS and centrifugation and resuspending using process media with no antibiotics. The collected mixture is then suspended in a cryoprotectant to form the biological composition, and the biological composition is frozen, including cryoprotectant-treated frozen material intended for thaw-and-immediate use while maintaining biologic function and viability/MSC-like markers such as CD105 and STRO-1.
Claims Coverage
The independent claim covers 6 inventive features centered on obtaining cadaver donor cortical and cancellous bone with bone marrow, mechanically separating cellular and non-cellular components, concentrating and filtering the separated mixture, collecting from a density gradient interface, washing and resuspending with DPBS and process media with no antibiotics, and suspending in a cryoprotectant for freezing and direct implantation without washing or rinsing.
Cadaver donor bone including cortical bone, cancellous bone, and bone marrow
obtaining cadaverous bone including cortical bone, cancellous bone, and bone marrow cut from a vertebral body of a cadaver donor
Mechanically separating cellular and non-cellular components by tumbling and sieving
mechanically separating cellular and non-cellular components of the bone marrow from cadaverous bone by tumbling, sieving the cadaverous bone from a decanted fluid of the bone marrow containing the cellular and non-cellular components in a series of cycles
Concentrating and filtering decanted fluid through a blood filter
concentrating the decanted fluid by centrifugation and filtering the decanted fluid through a blood filter to form a mixture including the cellular and non-cellular components separated from the marrow tissue and remaining cancellous and cortical bone
Density gradient centrifugation interface collection
separating the mixture by density gradient centrifugation to form an interface of the cellular and non-cellular components and collecting from the interface the cells or non-cellular components or combinations thereof
DPBS washing with centrifugation and resuspension in process media with no antibiotics
washing the cells or non-cellular components or combination thereof in the mixture using DPBS and centrifugation, removing the supernatant, and resuspending the remaining pellet using process media with no antibiotics
Cryoprotectant suspension for direct implantation without washing or rinsing and freezing
suspending the mixture in a cryoprotectant to create the biological composition suitable for direct implantation in a subject without washing or rinsing and freezing the biological composition
Overall, the claim set emphasizes cadaver donor cortical and cancellous bone with bone marrow, mechanical separation of cellular and non-cellular components, concentration and filtering, density gradient interface collection, DPBS washing and resuspension in process media with no antibiotics, and cryoprotectant suspension followed by freezing for direct implantation without washing or rinsing.
Stated Advantages
Suitable for direct implantation in a subject without washing or rinsing
Maintenance of biologic function including viability/MSC-like markers (CD105 and STRO-1) after cryopreservation
Documented Applications
Thaw-and-immediate use of the cryoprotectant-treated, frozen biological composition for direct implantation in a subject
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