Cryopreserved MSC Bone Graft Material for Rapid Bone Regeneration

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Solution Overview

Problem

The long-lasting in vitro preparation of autologous mesenchymal stromal cells (MSCs) for bone grafts is a limiting factor in treating bone disorders and injuries, as it takes weeks to obtain sufficient cells for implantation.

Innovation Solution

A method involving seeding biological cell material, preferably MSCs, on a scaffold material like β-TCP powder or granules, followed by cryopreservation within a time span of 0 to 24 hours, to create an 'off-the-shelf' bone graft material.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If autologous MSCs are prepared through long-lasting in vitro expansion, then sufficient cell quantity for implantation is achieved, but preparation time extends to weeks

Engineering Contradiction:
Improvecell quantityVSAvoidpreparation time
Core Design Contradiction:
Quantity of substanceVSLoss of time

Solution Approach 1:

The patent applies preliminary action by pre-expanding and cryopreserving MSCs in advance (up to 24 hours before implantation) rather than expanding them immediately before use. This allows sufficient cell quantity to be prepared beforehand while reducing the critical in vitro expansion time to less than 24 hours, resolving the contradiction between achieving sufficient cell quantity and minimizing preparation time

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the time parameter from weeks (traditional in vitro expansion) to less than 24 hours (cryopreserved off-the-shelf product). By optimizing the expansion protocol and implementing cryopreservation, the patent transforms the cell preparation process to achieve both sufficient cell quantity and dramatically reduced preparation time

Inventive Principle:
Principle #35Parameter changes

2Loss of time

If MSCs are cryopreserved immediately after seeding, then preparation time is minimized, but cell viability and functionality must be maintained

Engineering Contradiction:
Improvepreparation timeVSAvoidcell viability
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The patent applies beforehand cushioning by implementing cryopreservation protocols with protective agents and controlled freezing conditions before the cells are needed. This protective measure ensures cell viability is maintained during the cryopreservation process and subsequent storage, allowing immediate use without compromising cell functionality

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The patent utilizes phase transitions by cryopreserving the MSCs in a frozen state for storage and then thawing them immediately before implantation. This phase transition approach allows the cells to be prepared in advance while maintaining viability, resolving the contradiction between minimizing preparation time and maintaining cell reliability

Inventive Principle:
Principle #36Phase transitions

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

This approach allows for the production of a cryopreserved bone graft material that is osteo-inductive and can be used immediately, reducing preparation time and maintaining cell viability for effective bone regeneration and treatment.

Implementation Method 1

Seeding biological cell material on a scaffold material

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

Cryopreserving the bone graft material obtained in the first step

Methodology Applied
Scientific EffectFreezing: Freezing

Data Source

PatentEP4013469B1Mesenchymal stromal cell bone graft material
Publication Date: 2026.04.22 JOHANN WOLFGANG GOETHE UNIV FRANKFURT AM MAIN
  • EP4013469B1 patent drawingFigure 1
  • EP4013469B1 patent drawingFigure 2
  • EP4013469B1 patent drawingFigure 3

AI summary

The invention pertains to the use of mesenchymal stromal cells (MSC) in the treatment of bone disorders or injuries. The invention provides MSC and preparations of specifically pooled MSC for use in the manufacturing of bone graft material for implanting into or attaching to bones in order to enhance bone regeneration after surgery or injury, or to treat various bone disorders, such as osteonecrosis. The invention provides bone graft material, a method for its production, bone graft implants, and medical methods and uses of the inventive products.