Bone Marrow Biologic Composition for Allogeneic Therapy
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Solution Overview
Problem
Current stem cell therapies face challenges in producing safe allogeneic compositions with high yields of viable stromal cells, as existing methods struggle to remove antigenic properties leading to inflammation, thereby degrading cell quantity and functionality.
Innovation Solution
A biological composition derived from bone marrow, comprising non-expanded, non-differentiated cells and cellular components, treated with a cryoprotectant to maintain viability and pluripotency, which enhances regenerative resonance and tissue complexity, utilizing a method that includes mechanical separation, centrifugation, and cryopreservation to achieve increased CD105 and STRO1 markers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If stem cells are culturally expanded to increase cell quantity, then the yield of viable stromal cells is improved, but the risk of introducing antigenic properties and inflammation increases
Solution Approach 1:
The patent applies preliminary action by performing mechanical separation and density gradient centrifugation on bone marrow before cell culture expansion. This preliminary processing enriches for mesenchymal stromal cells with desired markers (CD105, STRO-1) while removing antigenic components, thereby enabling safe allogeneic use without requiring extensive culture expansion that would amplify risk.
Solution Approach 2:
The patent extracts and removes antigenic properties and unwanted cell types through mechanical separation and density gradient centrifugation. By taking out harmful components during the separation process, the patent achieves safe allogeneic compositions while maintaining high yields of viable, marker-positive stromal cells without relying on culture expansion.
2Reliability
If mechanical separation and density gradient centrifugation are used to remove antigenic properties, then the safety of the composition is improved, but the quantity of viable cells that can be harvested is degraded
Solution Approach 1:
The patent applies parameter changes by optimizing density gradient centrifugation conditions (density, temperature, centrifugal force) to selectively separate cells based on their physical properties. By carefully controlling these parameters, the patent maximizes the recovery of viable mesenchymal stromal cells with desired markers while simultaneously removing antigenic components, thus achieving both safety and high cell yield.
3Quantity of substance
If cells are processed and separated to yield only certain stromal cell types, then the purity of the composition is improved, but the complexity of the manufacturing process increases
Solution Approach 1:
The patent applies segmentation by dividing the bone marrow processing into distinct sequential steps: mechanical separation to remove debris, density gradient centrifugation to separate cell types based on density, and selective collection of the desired stromal cell layer. This segmentation allows each step to be optimized independently, achieving high purity of mesenchymal stromal cells (CD105+, STRO-1+) while managing process complexity through systematic breakdown of the separation process.
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 method results in a safe and effective biological composition that maintains high cell viability and pluripotency, enabling enhanced tissue regeneration with increased mesenchymal cells capable of differentiating into various tissue forms, while minimizing inflammation and maintaining cell vitality.
Implementation Method 1
The mixture is treated in a protectant or cryoprotectant prior to preservation or cryopreservation
Implementation Method 2
separation by density gradient centrifugation
Data Source
AI summary
A biological composition has a mixture of mechanically selected allogeneic biologic material derived from bone marrow. The mixture 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. The mixture is compatible with biologic function.