Ready-to-print cells and integrated devices
Inventors
Rowley, Jonathan Allen • Lock, Lye Theng
Assignees
Publication Number
US-11058106-B2
Publication Date
2021-07-13
Expiration Date
2035-05-12
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Abstract
Disclosed herein are compositions, devices, and methods that provide cellular materials in ready to use formats for experimental, therapeutic, and tissue engineering protocols. For example, compositions containing frozen or non-frozen cell present as aggregates are disclosed. Also disclosed a compositions containing cellular materials that after storage are suitable for dispersion, e.g. by 3D printing. Also disclosed is a kit for producing bioink compositions. Also disclosed is a closed system device comprising a cell material composition described herein.
Core Innovation
The invention provides compositions, devices, and methods delivering cellular materials in ready-to-use formats for experimental, therapeutic, and tissue engineering protocols. Specifically, it discloses compositions comprising viable cell aggregates, such as mesenchymal stem cells (MSCs), in both frozen (cryopreserved) and non-frozen (biopreserved) states. The aggregates typically contain from about 1,000 to 200,000 MSCs per aggregate, can be stored long-term, and are formulated so that they remain suitable for applications such as 3D bioprinting after storage.
Cell aggregates are suspended in a viscous matrix that can include biocompatible polymers, such as alginate, to maintain their viability and functional properties. These formulations provide a consistent and uniform product with minimal variance in aggregate size and cell density. The invention further encompasses kits for producing bioink compositions, enabling fast and reproducible preparation of printing materials, and closed system devices such as cartridges pre-loaded with the described cell compositions for controlled dispensing in applications like 3D tissue printing.
A core challenge addressed is the lack of standardized, high-quality, and cost-effective cellular materials—especially mesenchymal stem cells in ready-to-use and stable formats—that possess adequate shelf life for tissue engineering and cell therapy. The disclosed invention resolves this by delivering highly viable, functional cell aggregates with extended storage capabilities, simplifying and expediting the supply of living cells for regenerative medicine applications.
Claims Coverage
There are three main independent inventive features identified in the claims: (1) in vitro compositions of MSC aggregates in a viscous matrix with preservation agents, (2) kits comprising these compositions, a biocompatible polymer, and a crosslinking agent, and (3) closed system devices containing the composition for discrete and controlled dispensing.
In vitro compositions of MSC aggregates in a viscous matrix with preservation agents
An in vitro composition containing: - A viscous matrix. - Aggregates of viable mesenchymal stem cells (MSCs) suspended in the viscous matrix, where each aggregate contains on average 1,000–200,000 MSCs, and the overall average cell density is at least one million cells per milliliter. - Either a biopreservative agent (Hypothermosol®) sufficient to maintain aggregate fusion ability after 7 days at 4 °C or a cryopreservative agent (Cryostor®) suitable for cryopreservation of the MSC aggregates.
Kit containing preserved MSC aggregate composition, biocompatible polymer, and crosslinking agent
A kit comprising: - The above in vitro composition of MSC aggregates in a viscous matrix with preservation agent. - A biocompatible polymer. - A crosslinking agent.
Closed system device containing MSC aggregate composition for controlled dispensing
A closed system device comprising the above MSC aggregate composition, configured to dispense the composition as discrete units with controlled amounts of cells. The device can be a cartridge, and may be specifically designed for use in a three-dimensional (3D) printer device.
Collectively, the inventive features protect compositions of viable MSC aggregates preserved for stability and functionality, kits for preparing bioinks incorporating such aggregates, and closed system dispensing devices—each enabling ready-to-use, high viability cellular materials for tissue engineering and bioprinting applications.
Stated Advantages
Enables ready-to-use formats of mesenchymal stem cell aggregates that save researchers and clinicians significant time compared to conventional cell expansion and preparation.
Maintains high cell viability and critical biological functions (adhesion, proliferation, differentiation, cytokine secretion, immunomodulation) after long-term storage, either at refrigerated or cryogenic conditions.
Provides standardized, high-quality, and cost-effective cellular materials suitable for experimental, therapeutic, and tissue engineering protocols.
Decreases the variability and inconsistency seen in manual preparation by delivering cell aggregates with uniform size and density in a controlled, reproducible manner.
Facilitates rapid product development and reduces the time and economic burdens of cell culture and preparation steps, translating to significant cost savings in manufacturing environments.
Enables easy and immediate use in 3D bioprinting and cell therapy due to compatibility with dispensing/printing devices and long shelf-life.
Documented Applications
Experimental protocols requiring standardized, viable cell aggregates.
Therapeutic and cell therapy applications, including functional implantable objects.
Tissue engineering protocols using MSC aggregates as building blocks for engineered tissues.
3D bioprinting for manufacturing tissue constructs and organs using the bioink compositions.
Use in closed system devices, such as cartridges, for dispensing or printing living cells.
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