Neonatal Stromal Cell Freezing Protocol for Standard Storage
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Solution Overview
Problem
Current methods for preserving mesenchymatous stromal cells (MSCs) are expensive, require specialized equipment, and result in significant cell viability loss at temperatures between −20° C. and 4° C., making them unsuitable for widespread clinical use.
Innovation Solution
A method involving freezing neonatal stromal cells (NSCs) at temperatures between −70° C. and −140° C., followed by storage at −10° C. to −40° C., which maintains cell viability and immunomodulating activity for extended periods using standard, inexpensive freezers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If MSCs are preserved at temperatures between −20° C. and 4° C., then preservation cost is reduced and ease of operation is improved, but cell viability drops significantly by around 50%
Solution Approach 1:
The patent applies preliminary action by pre-freezing the cell suspension at ultra-low temperatures (−80° C. to −195° C.) before transferring to standard freezer temperatures. This preliminary ultra-low temperature treatment prepares the cells for subsequent storage at higher temperatures, enabling them to maintain viability that would otherwise be lost. The pre-freezing step creates a stable cellular state that can withstand the less optimal but more accessible storage conditions.
2Reliability
If MSCs are preserved using ultra-low temperature conditions (−80° C. to −195° C.), then cell viability is maintained, but expensive specialized equipment and facilities are required
Solution Approach 1:
The patent applies segmentation by dividing the preservation process into two distinct stages: an initial ultra-low temperature freezing stage (−80° C. to −195° C.) for a limited period, followed by a long-term storage stage at standard freezer temperatures (−20° C. to 4° C.). This segmentation allows the system to benefit from ultra-low temperature protection during the critical freezing phase while using accessible, less complex equipment for extended storage, thereby reducing overall device complexity and cost.
Solution Approach 2:
The patent applies preliminary action by performing the critical ultra-low temperature freezing treatment before transferring cells to standard freezers. This preliminary action at ultra-low temperatures prepares the cellular structure and cryoprotectant distribution, enabling subsequent storage at higher temperatures without significant viability loss. This approach eliminates the need for continuous ultra-low temperature infrastructure.
3Device complexity
If MSCs are frozen and stored at standard freezer temperatures (−20° C. to 4° C.), then preservation cost and device complexity are reduced, but therapeutic efficacy is compromised due to viability loss
Solution Approach 1:
The patent applies preliminary action by implementing an initial ultra-low temperature freezing protocol before standard freezer storage. This preliminary treatment at −80° C. to −195° C. for a defined period establishes optimal cryoprotectant distribution and cellular ice crystal formation, which protects cell membranes and structures during subsequent storage at higher temperatures. This ensures therapeutic efficacy is maintained despite using accessible storage equipment.
Solution Approach 2:
The patent applies segmentation by separating the preservation protocol into an initial ultra-low temperature phase followed by standard temperature storage. This segmentation allows the system to achieve the cellular protection benefits of ultra-low temperature while using cost-effective standard freezers for long-term storage, thereby maintaining therapeutic efficacy without requiring continuous expensive infrastructure.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method ensures the long-term preservation of NSCs with high viability and metabolic activity, maintaining therapeutic efficacy for several months without the need for expensive equipment or specialized storage.
Implementation Method 1
a method for freezing and preserving a composition comprising a population of neonatal stromal cells and a cryoprotector
Implementation Method 2
comprising a step of freezing at between −70° C. and −140° C. followed by a step of preservation at between −10° C. and −40° C.
Data Source
AI summary
The present invention relates to a method for freezing and preserving a composition comprising a population of neonatal stromal cells (NSCs) and a cryoprotector, characterised in that it comprises a step of freezing the composition at a temperature of between −70° C. and −140° C., then a step of preserving the composition at between −10° C. and −40° C. The present invention also relates to a composition comprising a population of NSCs and a cryoprotector, characterised in that it is preserved at between −10° C. and −40° C., said NSCs being in particular placental NSCs.