Acellular Amnion Composition for Stable Therapeutic Storage
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Solution Overview
Problem
Current therapeutic compositions using amnion-derived materials with live amniotic cells require stringent handling and maintenance of temperature, which can be cumbersome and impractical for widespread application, whereas acellular materials without live cells could offer simpler handling and storage.
Innovation Solution
Development of an acellular amnion-derived therapeutic composition comprising amniotic membrane, fluid, or derived components like proteins and growth factors, with no live or active amniotic cells, allowing for concentration or dilution, and potentially combined with additional therapeutic agents or cells, to create a stable and versatile treatment option.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If live amniotic cells are used in therapeutic compositions, then therapeutic efficacy is improved, but handling and storage requirements become more stringent
Solution Approach 1:
The invention extracts and removes live amniotic cells from the therapeutic composition while retaining the beneficial acellular components such as growth factors, cytokines, and extracellular matrix proteins. This extraction resolves the contradiction by eliminating the handling and storage constraints associated with live cells while preserving the therapeutic efficacy of the remaining bioactive molecules.
Solution Approach 2:
The invention changes the critical parameter of cell viability from 'required' to 'absent' by applying decellularization processes. This parameter change transforms the composition from one requiring stringent temperature and handling controls to one that can be stored and handled more easily, while maintaining therapeutic effectiveness through preserved growth factors and proteins.
2Reliability
If amniotic cells are maintained in proper condition, then cell viability is preserved, but handling complexity increases
Solution Approach 1:
The invention removes live cells from the composition entirely, eliminating the need for complex handling protocols required to maintain cell viability. The therapeutic composition retains effectiveness through acellular components that do not require specialized maintenance conditions.
3Ease of operation
If acellular amnion derived material is used, then handling and storage become easier, but therapeutic efficacy may be reduced
Solution Approach 1:
The invention optimizes the concentration parameters of acellular components such as growth factors, cytokines, and extracellular matrix proteins to ensure therapeutic efficacy is maintained or enhanced. By carefully controlling these concentration parameters, the composition achieves effectiveness without requiring live cells, thus maintaining ease of handling and storage.
Solution Approach 2:
The invention creates a composite therapeutic composition that combines multiple acellular amnion-derived components including growth factors, cytokines, and extracellular matrix proteins. This composite approach ensures that therapeutic efficacy is maintained through the synergistic action of multiple bioactive molecules rather than relying on single components or live cells.
Data Source
Figure 1A~1B
Figure 2A
Figure 2B
AI summary
Acellular amnion derived therapeutic compositions are described having a number of various com positional embodiments. An acellular amnion derived therapeutic composition has essentially no live or active amniotic cells. The amniotic cells may be destroyed and the cells and cell debris may be removed from the acellular amnion derived therapeutic composition. An acellular amnion derived therapeutic composition may comprise micronized placental tissue particles, and/or amniotic fluid. An acellular amnion derived therapeutic composition may be a dispersion of micronized amniotic membrane combined with a fluid, such as plasma, saline, amniotic fluid, combinations thereof and the like. An acellular amnion derived therapeutic composition may be combined with a matrix component to form a composite. An acellular amnion derived therapeutic composition may be used in conjunction with a composition comprising viable cells, such as stem cells.