Extracellular Vesicle Formulation With Active Cargo for Broad Disease Therapy

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Solution Overview

Problem

Existing extracellular vesicle (EV) formulations are limited in their therapeutic applications due to variability in disease treatment efficacy based on factors like disease type, severity, and EV properties, necessitating a modified EV formulation for wide-ranging disease treatment.

Innovation Solution

A formulation comprising EVs derived from mesenchymal stem cells isolated from Wharton's jelly, encapsulating active agents such as growth factors, immune-modulating agents, or nucleic acids, prepared through methods involving irradiation or pre-treatment of stem cells, to enhance therapeutic efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If EV formulations are used for therapeutic applications, then therapeutic benefits are achieved, but treatment efficacy varies due to disease type, severity, and EV properties

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoiddisease treatment range
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent applies universality by designing EV formulations that can treat multiple disease types (inflammatory, degenerative, cancer, infectious diseases, and aging) through a single platform. The EVs are engineered to carry diverse active agents including growth factors, immune-modulating agents, and nucleic acids, enabling one formulation system to address various therapeutic needs across different disease categories.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent employs parameter changes by modifying EV properties such as size, surface charge, and cargo content to optimize treatment efficacy for different diseases. The formulation adjusts parameters like EV concentration, active agent loading, and cellular origin characteristics to overcome the variability in treatment responses and achieve reliable therapeutic effects across diverse disease conditions.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If EVs are isolated from various biofluids for diagnostic use, then disease diagnosis is enabled, but the formulation lacks therapeutic capability

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtherapeutic effect
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent merges diagnostic and therapeutic functions by combining EV isolation from biofluids (which provides diagnostic accuracy through disease-specific EV markers) with therapeutic modification (loading EVs with active agents like growth factors and immune-modulating agents). This creates a dual-function formulation that maintains diagnostic capability while adding therapeutic efficacy.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If EV formulations are modified with pre-conditional culture stimulations or post-isolation incorporation, then therapeutic applications are improved, but formulation complexity increases

Engineering Contradiction:
Improvetherapeutic effectVSAvoidformulation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action through pre-conditional culture stimulations where EVs are prepared in advance with specific active agents loaded during the culture phase. This preliminary modification ensures therapeutic efficacy is built into the formulation before administration, reducing the need for complex post-preparation steps while maintaining reliable therapeutic effects.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS12559725B2Formulation comprising extracellular vesicles, method for producing the same, and uses thereof
Publication Date: 2026.02.24 MACKAY MEMORIAL HOSPITAL
  • US12559725B2 patent drawing
  • US12559725B2 patent drawing
  • US12559725B2 patent drawing

AI summary

Disclosed herein is a formulation comprising an extracellular vesicle (EV), and a therapeutic active agent induced or embedded in the EV. According to preferred embodiments of the present disclosure, the EV is isolated from umbilical cord mesenchymal stem cells, and the active agent may be a growth factor, an immune-modulating agent, a small molecule, an siRNA, cDNA or a plant ingredient; for example, curcumin. Also disclosed herein are methods for producing the present formulation, and uses of the present formulation in the treatment of various diseases.