Polyampholyte Shroud for Cell Viability and Safety
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Solution Overview
Problem
Current methods for producing safe allogeneic tissue regenerative compositions face challenges in removing antigenic properties to minimize inflammation, leading to degradation of viable cell quantities during the separation process, making it difficult to achieve zero risk and effective harvesting of stromal cell types.
Innovation Solution
A biologic composition is developed using a mixture of non-whole cellular components and whole cells from bone marrow, coated with a polyampholyte protectant that forms a three-dimensional bonding shroud to deter cell attachment, buffer inflammation, and sustain regenerative potential, which is metabolized after implantation, allowing for direct implantation and maintaining biologic function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If stem cells are isolated and purified through separation processes to remove antigenic properties, then safety and reduction of inflammation are improved, but the quantity of viable cells is degraded
Solution Approach 1:
The patent extracts and removes antigenic properties and inflammatory factors from the stem cell mixture through separation processes, isolating specific stromal cell types while discarding harmful components. This extraction approach achieves safety by eliminating antigenic properties while maintaining viable cells through selective separation rather than complete purification.
Solution Approach 2:
The patent introduces an intermediary substance or matrix that facilitates the separation and purification process. This intermediary allows for the selective removal of antigenic properties while preserving viable cells, acting as a mediator between the raw cell mixture and the final safe composition.
2Reliability
If separation processes are applied to remove antigenic properties, then safety is improved, but the complexity of the manufacturing process increases
Solution Approach 1:
The patent segments the separation process into distinct stages, each targeting specific antigenic properties or cell types. This segmentation allows for systematic removal of harmful components while simplifying each individual step, making the overall complex process more manageable and controllable.
Solution Approach 2:
The patent utilizes parameter changes such as density, magnetic properties, or chemical characteristics to enable separation. By adjusting these parameters, the process can selectively isolate stromal cells while removing antigenic properties, reducing the need for complex multi-step procedures.
3Adaptability or versatility
If whole cells are used to maintain regenerative potential, then biologic function is improved, but the risk of inflammation and immune rejection increases
Solution Approach 1:
The patent extracts and removes cell membranes and other antigenic structures from whole cells while retaining the nuclear material and regenerative potential. This extraction creates a composition that maintains biologic function without the harmful immune rejection properties associated with intact cell membranes.
Solution Approach 2:
The patent applies different treatments to different parts of the cell. The nuclear material is preserved to maintain regenerative potential, while the cell membrane and surface structures are removed or modified to eliminate antigenic properties. This local differentiation allows simultaneous achievement of safety and functionality.
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
The composition achieves safe and effective tissue regeneration by maintaining cell viability and regenerative potential, reducing premature differentiation, and minimizing inflammation, with the polyampholyte protectant providing a stable interface that protects the cell membrane and supports tissue complexity and pluripotency.
Implementation Method 1
The bonding shroud also buffers inflammation and further can retard or reduce premature differentiation of the whole cells of the mixture
Implementation Method 2
The bonding shroud deters attachment to other cells for a predetermine time
Implementation Method 3
The three-dimensional bonding shroud forms a spherical shell about each whole cell. Preferably, the polyampholyte protectant is a cryoprotectant. The protectant when frozen as a cryoprotectant interrupts crack propagation externally protecting the cell membrane
Implementation Method 4
The polyampholyte protectant forms a strong hydrophilic characteristic of the bonding shroud to protect the cell membrane external of the whole cells
Implementation Method 5
The protectant when frozen as a cryoprotectant interrupts crack propagation externally protecting the cell membrane
Data Source
AI summary
A biological composition intermixed with a polyampholyte protectant for direct implantation has a mixture of biologic material and a volume of polyampholyte protectant. The mixture of biologic material has non-whole cellular components including vesicular components and active and inactive components of biological activity, cell fragments, cellular excretions, cellular derivatives, and extracellular components, or whole cells or combinations of the non-whole cellular components and whole cells, wherein the mixture is compatible with biologic function. The volume of polyampholyte protectant is intermixed with the mixture of biologic material, wherein the polyampholyte protectant is a liquid of a polyamine polymer compound of carboxylated poly-lysine and wherein the polyampholyte protectant forms a three-dimensional bonding shroud externally enveloping each of the non-whole cellular components, if any, and each of the whole cells, if any, of the mixture of biologic material.