Amniotic Fluid Treatment for M1-to-M2 Polarization in Chronic Wounds

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Chronic inflammatory conditions, such as diabetic ulcers, are characterized by an imbalance in M1 and M2 macrophage populations, leading to persistent inflammation and hindered wound healing due to excessive M1 macrophages, with traditional treatments providing limited efficacy.

Innovation Solution

Utilizing amniotic fluid from eggs or embryos of specific developmental stages to promote the transformation of M1 macrophages into M2 macrophages through the TLR4/NF-κB signaling pathway, thereby regulating macrophage balance and enhancing wound healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional debridement and dressing therapies are used for diabetic ulcers, then the treatment process is simple and easy to operate, but the treatment efficacy is limited and wounds remain prolonged and recurrent

Engineering Contradiction:
Improvetreatment efficacyVSAvoidtreatment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces amniotic fluid as an intermediary substance that mediates the transformation from M1 to M2 macrophages. The amniotic fluid contains specific factors that activate the TLR4/NF-κB signaling pathway, serving as a bridge between the existing inflammatory state and the desired anti-inflammatory state, thereby improving treatment efficacy without requiring complex surgical interventions

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the biochemical parameters of the wound environment by applying amniotic fluid, which alters the macrophage polarization state. This parameter change shifts the immune response from pro-inflammatory (M1) to anti-inflammatory (M2), effectively treating the underlying chronic inflammation that prevents wound healing

Inventive Principle:
Principle #35Parameter changes

2Reliability

If M1 macrophages are present in excessive numbers in diabetic wounds, then phagocytosis of necrotic tissues is enhanced, but inflammation is prolonged and transformation to M2 macrophages is hindered

Engineering Contradiction:
Improvewound healing progressVSAvoidinflammation duration
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent applies a dynamic approach by promoting the transformation of macrophages from one state (M1) to another (M2). The amniotic fluid creates conditions that enable this dynamic transition, allowing the immune response to evolve from the initial pro-inflammatory phase to the reparative phase, thereby resolving the contradiction between effective phagocytosis and prolonged inflammation

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent establishes a feedback mechanism where amniotic fluid application triggers signaling pathways (TLR4/NF-κB) that regulate macrophage polarization. This feedback loop monitors and adjusts the immune response, ensuring that inflammation is adequately mounted initially but then appropriately resolved as M2 macrophages take over, preventing chronic inflammation

Inventive Principle:
Principle #23Feedback

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 amniotic fluid induces M2 macrophage polarization, reducing inflammation and promoting tissue repair in chronic inflammatory conditions like diabetic ulcers, effectively addressing the imbalance and enhancing healing processes.

Implementation Method 1

the Toll-like receptor 4 (TLR4)/NF-xB signaling pathway plays a central regulatory role in inflammatory responses. Upon stimulation by TLRs and cytokine receptors including TNF receptors, activation of IκB kinase induces IκB phosphorylation, further causing proteasomal degradation and subsequent release of NF-κB for translocation toward the nucleus

Methodology Applied
Scientific EffectTLR4/NF-κB signaling pathway activation:

Data Source

PatentEP4606381A1Drug for treating or preventing macrophage-mediated diseases and use thereof
Publication Date: 2025.08.27 ANHUI HYGEIANCELLS BIOMEDICAL CO LTD
  • EP4606381A1 patent drawingFigure 1A~1B
  • EP4606381A1 patent drawingFigure 1C~1D
  • EP4606381A1 patent drawingFigure 2A~2B

AI summary

Disclosed are the uses of amniotic fluid in the preparation of a drug for treating and/or preventing macrophage-mediated diseases, a drug for treating and/or preventing type M1 macrophage-mediated diseases, a drug for treating and/or preventing type M2 macrophage-mediated diseases, a preparation for treating and/or preventing TLR4/NF-κB signaling pathway-mediated diseases, a preparation for inhibiting the number of type M1 macrophages and increasing the proportion of type M2 macrophages or a preparation for promoting the conversion of type M1 macrophages to type M2 macrophages. The amniotic fluid is from eggs at an embryo age of 5-12 days, or eggs from poultry other than chickens at the development stage corresponding to the development stage of the above-mentioned eggs at the embryo age; or embryos of rodent animals at the embryo age of 8-14 days, or embryos of non-human mammals other than rodent animals at the development stage corresponding to the development stage of the above-mentioned rodent animals at the embryo age of 8-14 days.