Acellular Amnion Composition for Stable Regenerative Therapy
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Solution Overview
Problem
Current therapeutic compositions using amnion-derived materials require stringent handling due to the presence of live amniotic cells, which are fragile and can become inactive if not maintained properly, limiting their application and storage.
Innovation Solution
Development of acellular amnion-derived therapeutic compositions that are free of live or active amniotic cells, focusing on amniotic membrane, amniotic fluid, and derived proteins like growth factors and cytokines, with optional inclusion of non-amniotic cells for enhanced healing and regenerative effects, allowing for less stringent handling and storage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If live amniotic cells are used in therapeutic compositions, then enhanced healing and regenerative properties are achieved, but stringent handling and storage requirements are imposed due to cell fragility
Solution Approach 1:
The patent extracts and removes live amniotic cells from the therapeutic composition, retaining only the acellular components (amniotic membrane, amniotic fluid, growth factors, cytokines, and other bioactive molecules). This extraction eliminates the fragility and handling issues associated with live cells while preserving the therapeutic benefits of the amniotic-derived bioactive substances.
Solution Approach 2:
The patent changes the physical and biological state of the amnion-derived material by transitioning from a living cellular system to an acellular composition. This parameter change (from viable cells to non-viable but bioactive material) fundamentally alters the handling, storage, and stability characteristics while maintaining therapeutic efficacy through the preservation of growth factors, cytokines, and other bioactive molecules.
2Reliability
If live amniotic cells are maintained in proper condition, then cell viability and therapeutic effectiveness are preserved, but complex temperature control and handling protocols are required
Solution Approach 1:
The patent removes the requirement for temperature control and handling protocols by extracting and eliminating the live cells that necessitate such complex management. The acellular composition no longer requires refrigeration, controlled environments, or specialized handling procedures, thereby simplifying the entire supply chain and clinical application process.
Solution Approach 2:
The patent creates a stable, non-living therapeutic product that does not require ongoing maintenance or special conditions. The acellular composition can be stored and transported under常规 conditions, effectively replacing the need for complex life-sustaining infrastructure and protocols.
3Ease of operation
If amniotic cells are removed to create acellular composition, then handling and storage requirements are reduced, but potential loss of cell-based regenerative capabilities occurs
Solution Approach 1:
The patent creates an acellular copy or representation of the functional benefits of amniotic tissue by concentrating and preserving growth factors, cytokines, and other bioactive molecules that mediate the regenerative effects. This copying approach captures the essential therapeutic mechanisms without requiring the presence of intact living cells.
Solution Approach 2:
The patent shifts the therapeutic mechanism from cell-based regeneration to molecule-based therapy by changing the active components from viable cells to stabilized bioactive molecules. This parameter change allows the composition to exert regenerative effects through growth factors and cytokines that can diffuse and stimulate tissue repair without requiring living cell transplantation.
Data Source
AI summary
Acellular amnion derived therapeutic compositions are described having a number of various compositional 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.