Adipose-Derived Stem Cell Cryopreservation for Off-the-Shelf Therapy
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Solution Overview
Problem
Current methods for producing and preserving adipose-derived stem cells (ASCs) are less than optimal, hindering their widespread therapeutic applications due to inefficiencies and suboptimal clinical logistics.
Innovation Solution
A process involving the use of a bioreactor system with serum-free culture medium and human platelet lysate for ASC expansion, followed by cryopreservation in a protein-free cryoprotectant, allowing for high-concentration, high-quality ASC preparations suitable for both autologous and allogeneic uses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If current ASC production methods are used, then ASCs can be produced for therapy, but the production efficiency and clinical logistics are suboptimal
Solution Approach 1:
The patent applies preliminary action by cryopreserving ASCs in advance at high concentrations in protein-free cryoprotectant, creating ready-to-use formulations that eliminate complex clinical logistics. The ASCs are prepared, quality-controlled, and stored before clinical need, allowing rapid deployment without complex manufacturing logistics during treatment.
Solution Approach 2:
The patent changes key parameters including cell concentration (at least 1×10^7 cells/mL), cryoprotectant composition (protein-free), and storage conditions (cryopreservation). These parameter changes enable efficient production and simplify clinical logistics by creating stable, shelf-ready products.
2Quantity of substance
If ASCs are cryopreserved at high concentration, then off-the-shelf readiness is achieved, but cryopreservation quality must be maintained
Solution Approach 1:
The patent uses protein-free cryoprotectant as an intermediary substance that enables high-concentration cryopreservation while maintaining cell viability. The cryoprotectant mediates between the high cell concentration requirement and the need to preserve cell quality, preventing ice crystal formation and cellular damage during freezing and thawing.
Solution Approach 2:
The patent changes the physical state and composition parameters by using protein-free cryoprotectant formulations and controlling freezing/thawing conditions. These parameter changes allow achieving at least 1×10^7 cells/mL concentration while maintaining high viability after cryopreservation.
3Manufacturing precision
If serum-free culture medium with human platelet lysate is used, then ASC expansion quality is improved, but formulation complexity increases
Solution Approach 1:
The patent applies taking out by removing serum components and using only human platelet lysate as the supplementation source. This extraction approach simplifies the formulation by eliminating complex serum compositions while maintaining ASC expansion quality and homogeneity through the concentrated growth factors in platelet lysate.
Solution Approach 2:
The patent uses human platelet lysate as a composite material containing multiple growth factors, cytokines, and bioactive molecules. This single composite supplementation source replaces complex serum formulations and achieves high ASC expansion quality and homogeneity.
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 process enables the production of a homogenous ASC population with high viability and immunosuppressive properties, suitable for off-the-shelf use in therapies for autoimmune and ischemic disorders, with efficient yield and stability even after cryopreservation.
Implementation Method 1
cultivating adherent cells to confluence in a serum-free culture medium supplemented with human platelet lysate
Implementation Method 2
freezing the detached cells in a cryoprotectant at a concentration of at least 1×10^6 cells/mL
Data Source
AI summary
The present invention relates to adipose-derived stem cells (ASCs) and compositions, as well as methods for preparing and using such ASCs and compositions for therapy.