Amnion-Derived Cell Purification Using Monoclonal Antibodies
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Solution Overview
Problem
Current stem cell therapies face challenges in isolating and purifying amnion-derived cells from placental-derived stem cells, as existing methods lack specific protein markers for characterization and differentiation, leading to contamination with other stem cell types and inefficiencies in cell expansion and differentiation.
Innovation Solution
Development of specific protein markers such as CD9, CD10, CD26, CD71, CD166, CD227, EGF-R, SSEA-4, and HLA-G for characterizing and isolating amnion-derived cells, using monoclonal antibodies to create substantially purified populations, and expanding these cells to achieve higher concentrations for therapeutic use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional stem cell isolation methods are used, then cell population can be obtained, but the cells are contaminated with other stem cell types and lack specific characterization
Solution Approach 1:
The patent uses monoclonal antibodies as intermediary molecules to specifically bind to and isolate amnion-derived cells based on their unique surface protein markers (CD9, CD10, CD26, CD71, CD166, CD227, EGF-R, SSEA-4, HLA-G). This antibody-mediated approach enables precise cell purification without requiring complex multi-step isolation procedures, thereby improving measurement precision while maintaining operational simplicity.
2Productivity
If amnion-derived cells are isolated without specific markers, then isolation process is simpler, but cell expansion and differentiation efficiencies are reduced
Solution Approach 1:
The patent identifies a panel of multiple specific protein markers (CD9, CD10, CD26, CD71, CD166, CD227, EGF-R, SSEA-4, HLA-G) that are universally expressed on amnion-derived cells. This multi-marker system provides comprehensive cell characterization and enables simultaneous purification, expansion, and differentiation optimization, thereby improving productivity without excessive complexity.
3Manufacturing precision
If placental-derived stem cells are used, then cell population is available, but the cells exhibit heterogeneous protein expression and require extensive purification
Solution Approach 1:
The patent extracts and isolates specific amnion-derived cells from the heterogeneous placental-derived stem cell population by targeting unique surface protein markers (CD9, CD10, CD26, CD71, CD166, CD227, EGF-R, SSEA-4, HLA-G) that are selectively expressed on amnion cells. This extraction approach achieves high manufacturing precision by removing contaminating cell types while minimizing purification time through direct positive selection.
4Measurement precision
If existing stem cell markers are used for characterization, then general stem cell properties can be identified, but amnion-specific characteristics cannot be differentiated
Solution Approach 1:
The patent identifies and characterizes amnion-specific protein markers (CD9, CD10, CD26, CD71, CD166, CD227, EGF-R, SSEA-4, HLA-G) that are locally and specifically expressed on amnion-derived cells but not on other stem cell types. This local quality approach enables precise differentiation and characterization of amnion cells, preventing loss of amnion-specific information while maintaining accurate measurement precision.
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 use of these markers enables the isolation of pure amnion-derived cells, enhancing their expansion and differentiation capabilities, providing a nearly inexhaustible source for cell-based therapies with improved graft tolerance and wound healing properties.
Implementation Method 1
using monoclonal antibodies to create substantially purified populations
Implementation Method 2
Under appropriate conditions, placental-derived stem cells have been shown to differentiate into cells with characteristics of liver cells (hepatocytes), pancreatic cells (i.e. alpha and beta cells), central nervous system cells (neurons and glia), cardiac muscle cells (cardiomyocytes) and vascular endothelial cells
Data Source
AI summary
The invention is directed to substantially purified amnion-derived cell populations, compositions comprising the substantially purified amnion-derived cell populations, and to methods of creating such substantially purified amnion-derived cell populations, as well as methods of use. The invention is further directed to antibodies, in particular, monoclonal antibodies, that bind to amnion-derived cells or, alternatively, to one or more amnion-derived cell surface protein markers. The invention is further directed to methods for producing the antibodies, methods for using the antibodies, and kits comprising the antibodies.