Stem Cell Sheet Preservation for Ambient Wound Transport
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Solution Overview
Problem
Existing methods for transporting mesenchymal stem cells (MSCs) are limited by cell damage during short-distance transport and logistical complexities in long-distance transport, particularly under ambient conditions, and current spheropreservation techniques are cumbersome and difficult to scale for uneven surfaces.
Innovation Solution
A method involving a cell growth composition and transfer medium that maintains cell viability and function at ambient conditions for at least 21 days, using MEM alpha, fetal bovine serum, L-glutamine, antibiotics, and bFGF, with cells seeded on a scaffold to form a cell sheet, which can be transferred in a container with MEM alpha, DPBS, and fetal bovine serum.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If MSCs are transported using short-distance transport method with culture flasks and growth media at 37°C, then cell viability is maintained during transport, but the transport time is limited to 24 hours and requires expensive controlled environment equipment
Solution Approach 1:
The patent changes the temperature parameter from 37°C (incubator condition) to ambient temperature (2-25°C) by introducing a specific preservation medium containing human serum albumin, HEPES buffer, and antibiotics. This parameter change allows cells to be transported at room temperature for extended periods without requiring expensive incubator equipment, directly resolving the contradiction between maintaining cell viability and extending transport duration.
2Quantity of substance
If MSCs are transported using long-distance transport method with dry ice delivery and cryo-vials, then large quantities of cells can be moved, but the logistical complexity increases and additional costs are incurred
Solution Approach 1:
The patent extracts the cells from the complex cryopreservation system (dry ice, cryo-vials, specialized equipment) and places them in a simple ambient-temperature preservation medium. This removes the need for freezing equipment, dry ice replenishment, and specialized transport approvals, dramatically reducing logistical complexity while maintaining the ability to transport large quantities of cells.
3Reliability
If spheropreservation technique is used to store hMSC in spheroids under ambient conditions, then cell viability is preserved for one week without cryopreservation, but the technique is tedious and complex to scale up
Solution Approach 1:
Instead of forming complex 3D spheroid structures that require hanging-drop techniques and are difficult to scale, the patent segments the cells into a simple suspension format within the preservation medium. This segmentation approach maintains cell viability at ambient temperature while eliminating the tedious spheroid formation steps, making the process easily scalable to large quantities.
4Reliability
If cell spheroids with diameter of about 250 μm are used in spheropreservation, then cell viability is maintained, but the spheroids are difficult to apply to uneven surfaces such as diabetic foot wounds
Solution Approach 1:
The patent transforms the static, rigid 250 μm spheroid structure into a dynamic, adaptable cell suspension that can flow and conform to any wound surface geometry. The cells remain viable in the preservation medium but gain the flexibility to be applied to uneven surfaces like diabetic foot wounds, significantly improving adaptability while maintaining viability.
Data Source
AI summary
The present disclosure relates to the generation and use of cell sheets, in particular, stem cell sheets, which can preserve stem cell viability and function, and methods of assembling a medical device, methods of treating a wound, and kits comprising such sheets.