Growth-Factor Augmented Bone Graft for Faster Osteoinduction

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Solution Overview

Problem

Existing osteogenic compositions lack enhanced osteoinductive properties and efficacy in bone regeneration, necessitating innovative approaches to improve the effectiveness of biomaterials used in bone repair and regeneration.

Innovation Solution

The development of osteogenic compositions comprising growth-factor augmented cortical bone and cancellous bone, where the cortical bone is demineralized and amplified with growth factors, and the cancellous bone retains viable endogenous osteogenic cells, which are combined to form a cryopreserved or lyopreserved osteogenic composition.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If demineralized bone matrix is used to provide osteoconductive and osteoinductive properties, then the biomaterial can support bone growth, but the osteoinductive properties are insufficient for rapid bone regeneration

Engineering Contradiction:
Improveosteoinductive propertiesVSAvoidbone regeneration speed
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent combines demineralized bone matrix (DBM) with growth factors and viable osteogenic cells into a single composite osteogenic composition. This merging of multiple bioactive components (DBM for osteoconduction, growth factors for osteoinduction, and viable cells for immediate osteogenic activity) creates a synergistic effect that simultaneously improves reliability of bone growth support and accelerates the productivity of bone regeneration, resolving the contradiction between sufficient osteoinductive properties and rapid bone formation

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention creates a composite osteogenic material consisting of DBM particles, growth factors (such as BMPs, TGF-β, PDGF), and viable osteogenic cells embedded in a carrier matrix. This composite structure integrates multiple functional components that work together: DBM provides structural framework and osteoconduction, growth factors stimulate osteogenesis, and viable cells provide immediate bone-forming capability, thereby enhancing both the reliability and speed of bone regeneration

Inventive Principle:
Principle #40Composite materials

2Quantity of substance

If growth factors are extracted from demineralized bone using acidic solutions, then growth factors can be obtained for amplification, but the process requires precise control of pH and temperature parameters

Engineering Contradiction:
Improvegrowth factor concentrationVSAvoidextraction parameter control
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The patent performs preliminary demineralization of bone tissue before growth factor extraction, removing mineral components to facilitate subsequent acid extraction of growth factors. This preliminary action simplifies the extraction process by pre-processing the bone matrix, making growth factors more accessible and reducing the complexity of parameter control during the actual extraction phase, thereby obtaining higher growth factor concentrations with improved manufacturing precision

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention uses acidic solutions (such as HCl or citric acid) as intermediary agents to extract growth factors from demineralized bone. The acid acts as a mediator that selectively solubilizes growth factors while leaving other bone components intact. By controlling the acid concentration, pH, and extraction time, the process achieves high growth factor recovery without requiring extreme parameter control, resolving the contradiction between quantity obtained and manufacturing precision required

Inventive Principle:
Principle #24Intermediary (Mediator)

3Quantity of substance

If cancellous bone is subjected to loosening agents to release osteogenic cells, then more cells can be obtained, but the cells may lose their adherence to the bone matrix

Engineering Contradiction:
Improveosteogenic cell numberVSAvoidcell adherence to bone
Core Design Contradiction:
Quantity of substanceVSStability of the object's composition

Solution Approach 1:

The patent applies a partial action approach by using mild mechanical disruption or limited enzymatic treatment of cancellous bone to release a portion of osteogenic cells while maintaining enough matrix integrity to preserve cell adherence. Instead of completely dissociating the tissue, the process extracts sufficient viable cells for therapeutic use while leaving adherent cells attached to the bone matrix, thereby obtaining adequate cell numbers without compromising cell-bone stability

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The invention creates local quality differentiation within the osteogenic composition by having both detached osteogenic cells (available for migration and proliferation) and adherent osteogenic cells (maintained on bone matrix fragments for structural support and localized bone formation). This spatial and functional differentiation allows the composition to contain cells in different states, satisfying both the need for sufficient cell quantity and the need for stable cell-bone associations

Inventive Principle:
Principle #3Local quality

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 enhanced osteogenic composition demonstrates improved osteoinductive properties, accelerating bone growth and repair by leveraging the synergistic effects of growth factors and viable osteogenic cells, thereby enhancing the efficacy of bone regeneration.

Implementation Method 1

the growth factors are obtained from demineralized bone that has been soaked in an acidic solution to extract the growth factors

Methodology Applied
Scientific EffectAcid extraction: Solvation

Implementation Method 2

the osteogenic composition may be cryopreserved

Methodology Applied
Scientific EffectCryopreservation: Freezing

Implementation Method 3

the osteogenic composition may be lyopreserved

Methodology Applied
Scientific EffectLyophilization: Freeze Drying

Data Source

PatentUS20250387537A1Osteogenic compositions and methods of making the same
Publication Date: 2025.12.25 ALPHATEC SPINE INC
  • US20250387537A1 patent drawing
  • US20250387537A1 patent drawing
  • US20250387537A1 patent drawing

AI summary

An osteogenic composition comprises growth-factor augmented cortical bone and cancellous bone having viable endogenous osteogenic cells that remain adherent to the cancellous bone. The growth-factor augmented cortical bone comprises demineralized cortical bone amplified with growth factors derived from a demineralized bone, and the cancellous bone not having been subjected to a loosening agent. The osteogenic composition is cryopreserved or lyopreserved. A method for preparing an enhanced graft composition with improved osteoinductive properties includes processing demineralized cortical bone; solubilizing growth factors from demineralized bone; and mixing the demineralized cortical bone with the solubilized growth factors.