Adipose-Derived Stem Cell Conditioned Medium for Dry Eye Treatment

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Solution Overview

Problem

Current treatments for dry eye syndrome, such as lubricants and autoserum, are inconvenient and have inconsistent effects, and there is a need for a more effective medical composition that can efficiently prevent or treat dry eye disorders by leveraging the regenerative and anti-inflammatory properties of stem cells.

Innovation Solution

A bioactive formulation comprising an adipose-derived stem cell-conditioned medium (ADSC-CM) is prepared by culturing mesenchymal stem cells in a medium supplemented with serum and mesenchymal stem cell culture adjuvant, and then harvesting a fraction less than 30 kDa, which is used topically to treat epithelial tissue disorders like dry eye syndrome.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If punctal occlusion is used to decrease tear film loss, then tear film retention is improved, but inflammatory cytokines or enzymes in the tear film increase

Engineering Contradiction:
Improvetear film retentionVSAvoidinflammatory cytokines
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent extracts and removes inflammatory cytokines and enzymes from the tear film through filtration steps (0.22 μm filtration) in the preparation of conditioned medium, while retaining beneficial paracrine factors. This resolves the contradiction by eliminating harmful inflammatory components that would otherwise accumulate with tear film retention.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses an intermediary substance (conditioned medium containing paracrine factors) to mediate the treatment effect. This intermediary delivers anti-inflammatory and regenerative benefits without directly causing inflammation, thus resolving the contradiction between tear film retention and inflammation reduction.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If autologous serum drops are applied to provide lubrication and biochemical components, then some therapeutic effects are achieved, but preparation and preservation become inconvenient and effects become inconsistent

Engineering Contradiction:
Improvetherapeutic effectVSAvoidpreparation convenience
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent creates a standardized copy of the therapeutic components found in autologous serum by using conditioned medium with defined composition. This standardized formulation replicates the beneficial effects while eliminating the preparation and preservation inconveniences of actual patient serum through batch production and stable storage conditions.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent changes the physical and chemical parameters of the therapeutic formulation by using conditioned medium with controlled composition, pH, and sterility. This transforms the variable, hard-to-manage autologous serum into a consistent, stable product with reproducible therapeutic effects and convenient storage requirements.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If stem cells are used to provide regenerative and anti-inflammatory effects, then tissue healing is improved, but tumorigenic or antigenic properties may arise

Engineering Contradiction:
Improvetissue regenerationVSAvoidtumorigenic properties
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts only the beneficial paracrine factors from stem cells through conditioned medium preparation, while leaving behind the stem cells themselves. This separation removes potential tumorigenic and antigenic properties while retaining the regenerative and anti-inflammatory effects of stem cell secretions.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses conditioned medium as an intermediary that carries the therapeutic paracrine factors without containing living stem cells. This intermediary delivers the regenerative benefits while eliminating the safety risks associated with direct stem cell transplantation.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Ease of operation

If conventional treatment modalities are used for dry eye syndrome, then some symptomatic relief is achieved, but the treatments are not ideal in daily practice due to inconsistent effects

Engineering Contradiction:
Improvesymptomatic reliefVSAvoidtreatment consistency
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent changes the formulation parameters to create a standardized conditioned medium with defined composition, sterility, and stability. This standardization ensures consistent therapeutic effects across different patients and treatment instances, resolving the inconsistency problem of conventional treatments.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a reproducible copy of the ideal therapeutic composition through standardized preparation protocols. This ensures that each batch of conditioned medium delivers consistent effects, unlike variable autologous serum or conventional treatments.

Inventive Principle:
Principle #26Copying

Data Source

PatentUS12006515B2Composition and method for preventing or treating eye disorder
Publication Date: 2024.06.11 BUDDHIST TZU CHI GEN HOSPITAL
  • US12006515B2 patent drawing
  • US12006515B2 patent drawing
  • US12006515B2 patent drawing

AI summary

Provided is a method for preparing mesenchymal stem cell-conditioned medium, including isolating mesenchymal stem cells from a subject, maintaining the mesenchymal stem cells in a mesenchymal stem cell maintenance medium, collecting the mesenchymal stem cells at passages 2 to 5, culturing the mesenchymal stem cells in a medium supplemented with fetal bovine serum and mesenchymal stem cell culture adjuvant for hours to obtain a mesenchymal stem cell-conditioned medium, harvesting the medium and centrifuging followed by filtering. Also provided is a method for preventing or treating epithelial tissue disorder of eyes such as dry eye syndrome, including applying the medium to an eye of a subject. Further provided is a medical composition including the medium.