Term Amniotic Fluid Mesenchymal Stem Cells for Immune Modulation

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Solution Overview

Problem

Existing methods do not effectively reduce T cell activation, inhibit macrophage polarization, and inhibit cytokine secretion from activated Peripheral Blood Mononuclear Cells (PBMC) using mesenchymal stem cells, particularly those isolated from amniotic fluid.

Innovation Solution

Isolation and characterization of tissue-typed Term Amniotic Fluid Mesenchymal Stem Cells (TAF-MSCs) from amniotic fluid, which are co-cultured with T cells, macrophages, and PBMCs to reduce T cell activation, change macrophage polarization, and inhibit cytokine secretion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional mesenchymal stem cells are used for immunomodulation, then some immune suppression effect is achieved, but the effectiveness in reducing T cell activation, inhibiting macrophage polarization, and inhibiting cytokine secretion is insufficient

Engineering Contradiction:

Improveeffectiveness of immunomodulationVSAvoidcomplexity of cell isolation and characterization

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the source parameter of mesenchymal stem cells from conventional sources (bone marrow, adipose tissue) to term amniotic fluid, which fundamentally alters the cellular properties and immunomodulatory effectiveness. This parameter change in cell origin provides enhanced therapeutic effects while establishing new isolation protocols optimized for amniotic fluid samples

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent segments the complex cell isolation process into distinct methodological steps: amniotic fluid collection, cell culture expansion, phenotypic characterization, and functional validation. This segmentation makes the complex process systematic, reproducible, and clinically translatable while maintaining high cell purity and functionality

Inventive Principle:

Principle #1Segmentation

2Reliability

If term amniotic fluid mesenchymal stem cells are isolated and characterized, then effective immunomodulation is achieved, but the isolation and characterization process becomes complex

Engineering Contradiction:

Improveimmunomodulatory effectivenessVSAvoidisolation and characterization methodology

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent establishes a universal isolation and characterization protocol for term amniotic fluid mesenchymal stem cells that can be applied across different clinical scenarios and disease models. The methodology integrates multiple functions: cell isolation, expansion, phenotypic verification, and functional assessment into a standardized platform that serves diverse immunomodulatory applications

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent optimizes cultivation parameters specific to term amniotic fluid mesenchymal stem cells, including serum-free medium composition, oxygen tension, and passage conditions. These parameter optimizations enhance cell expansion efficiency and maintain immunomodulatory functionality while reducing contamination risks and simplifying downstream applications

Inventive Principle:

Principle #35Parameter changes

3Object-affected harmful factors

If TAF-MSCs are used to reduce inflammation, then tissue damage is reduced, but the complexity of cell therapy implementation increases

Engineering Contradiction:

Improveinflammation and tissue damageVSAvoidease of cell therapy implementation

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent performs preliminary expansion and characterization of term amniotic fluid mesenchymal stem cells before clinical application. Cells are pre-cultured to sufficient numbers, validated for identity and functionality, and prepared for storage or immediate use. This preliminary action simplifies clinical implementation by eliminating the need for complex per-procedure cell processing while ensuring consistent therapeutic quality

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent uses standardized cell culture media, growth factors, and culture conditions as intermediaries to facilitate the transition from cell isolation to therapeutic application. These intermediary elements bridge the gap between complex cell biology and simplified clinical delivery, enabling consistent cell production and facilitating regulatory approval and clinical implementation

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS12435308B2Immunomodulation by amniotic fluid mesenchymal stem cells

Publication Date: 2025.10.07 AMNIOTICS AB

AI summary

Methods of reducing T cell activation including co-culturing with T cells, term amniotic fluid mesenchymal stem cells (TAF-MSCs) isolated from term human amniotic fluid. Other aspects relate to methods of inhibiting macrophage polarization toward the M1 pro-inflammatory phenotype including co-culturing with macrophages TAF-MSCs isolated from term human amniotic fluid. Other aspects relate to methods of inhibiting cytokine secretion from activated Peripheral Blood Mononuclear Cell (PBMC) including co-culturing with the PBMC tissue-typed TAF-MSCs isolated from human amniotic fluid. Other aspects relate to methods of differentiating TAF-MSC including: obtaining TAF-MSC cells from term amniotic fluid, plating the TAF-MSC cells in limiting dilution to obtain expanded colonies from single cells, and transferring the cells to a differentiation media that contains one or more factor to differentiate the TAF-MSC cells.