Decellularized Intervertebral Disc Scaffold for Nucleus Pulposus Regeneration

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Solution Overview

Problem

Current therapies for intervertebral disc degeneration and herniation are palliative and do not address the regeneration or replacement of healthy nucleus pulposus tissue, with existing biomaterial scaffolds facing challenges in mimicking native microarchitecture, biochemistry, and mechanical properties, and in effectively supporting seeded cells.

Innovation Solution

A decellularized bovine intervertebral disc tissue is developed, treated with a decellularization solution containing non-ionic surfactants and protease inhibitors, followed by ultrasonication and enzyme treatment to remove cellular content, resulting in a biomaterial that retains glycosaminoglycans and collagen, mimicking native tissue properties and supporting cell viability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If decellularization methods are used to remove host cells from source tissue, then immunogenic materials are reduced, but desirable ECM components such as GAG are significantly reduced

Engineering Contradiction:
Improveimmunogenic materialsVSAvoidglycosaminoglycan content
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The patent applies different treatments to different components within the tissue: mild decellularization conditions preserve GAG-rich areas while removing cells, and selective enzymatic digestion removes DNA from collagen-rich areas while preserving GAGs. This localized differential treatment resolves the contradiction between removing immunogenic materials and preserving desirable ECM components.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent changes the parameters of decellularization treatment over time and space - using mild initial conditions to preserve GAGs, then applying selective enzymatic digestion later to remove DNA. This temporal and parametric progression allows separation of the two goals: first preserving GAG content, then removing immunogenic DNA without further GAG loss.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If aggressive decellularization methods are used to completely remove cell DNA, then immunogenicity is reduced, but the native ECM structure is disrupted

Engineering Contradiction:
Improvecell DNAVSAvoidnative ECM structure
Core Design Contradiction:
Object-affected harmful factorsVSStability of the object's composition

Solution Approach 1:

The patent performs preliminary mild decellularization to remove most cells while preserving ECM structure, then applies selective enzymatic digestion only to remaining DNA in collagen-rich areas. This staged approach prevents structural disruption that would occur with single-step aggressive treatment.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses selective enzymes as intermediaries that specifically target DNA in collagen-rich areas without affecting GAGs or overall ECM structure. These enzymes mediate between the need to remove DNA and the need to preserve native ECM architecture.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If pre-formed hydrogel scaffolds are used to support stem cells, then cell delivery is improved, but the scaffolds fail to mimic native tissue microarchitecture and biochemistry

Engineering Contradiction:
Improvecell deliveryVSAvoidtissue-specific ECM production
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The patent creates a scaffold by copying native tissue architecture through decellularization of actual intervertebral disc tissue. This natural template copying preserves the complex microarchitecture, GAG distribution, and biochemical cues that synthetic hydrogels cannot replicate, while still providing cell delivery capability.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent creates a composite scaffold containing multiple ECM components (collagen, GAGs, proteoglycans) in their native spatial relationships. This composite structure combines the structural support of collagen with the bioactive properties of GAGs, providing both mechanical integrity and biological functionality that homogeneous synthetic hydrogels lack.

Inventive Principle:
Principle #40Composite materials

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 biomaterial effectively supports cell viability and maintains mechanical properties similar to healthy intervertebral disc tissue, providing a promising scaffold for regenerating nucleus pulposus tissue and potentially addressing degeneration and herniation.

Implementation Method 1

treated with a decellularization solution containing non-ionic surfactants and protease inhibitors

Methodology Applied
Scientific EffectSurfactant: Surfactant

Implementation Method 2

treated with a decellularization solution containing non-ionic surfactants and protease inhibitors

Methodology Applied
Scientific EffectProtease inhibition: Enzyme

Implementation Method 3

followed by ultrasonication and enzyme treatment to remove cellular content

Methodology Applied
Scientific EffectUltrasonication: Ultrasonic Vibration

Implementation Method 4

followed by ultrasonication and enzyme treatment to remove cellular content

Methodology Applied
Scientific EffectEnzyme digestion: Enzyme

Data Source

PatentEP3347065B1Decellularized biomaterial and method for formation
Publication Date: 2022.06.29 CLEMSON UNIVERSITY
  • EP3347065B1 patent drawingFigure 1
  • EP3347065B1 patent drawingFigure 2
  • EP3347065B1 patent drawingFigure 3A~3D

AI summary

Methods for developing a decellularized tissue and biomaterials for use as biomimetic grafts or in vitro cellular scaffolds formed with the decellularized tissue are described. The biomaterials are particularly well suited for use as an intervertebral disc graft. The decellularized tissue is formed from an intervertebral disc source tissue and can be substantially decellularized and substantially free of potential immunogenic material (e.g., DNA and RNA), while maintaining ECM materials including both glycosaminoglycan and collagen.