Hypoxic Cell Culture ECM Compositions for Tissue Repair
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Solution Overview
Problem
Current methods for soft tissue repair and augmentation, such as collagen compositions and ceramic particles, face challenges including immunogenic reactions, high production costs, and limited long-term effectiveness, while treatments for coronary heart disease and osteochondral defects require more successful and sustainable solutions.
Innovation Solution
The development of extracellular matrix (ECM) compositions produced by culturing cells under hypoxic conditions on a surface, which include embryonic proteins, Wnt proteins, and vascular endothelial growth factor (VEGF), to promote tissue repair, regeneration, and vascularization, suitable for use in soft tissue augmentation, cardiovascular applications, and osteochondral defect repair.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If collagen compositions and ceramic particles are used for soft tissue repair, then tissue augmentation is achieved, but immunogenic reactions occur and long-term effectiveness is limited
Solution Approach 1:
The patent applies parameter changes by culturing cells under hypoxic conditions (low oxygen tension) rather than standard atmospheric oxygen levels. This parameter change in the culture environment induces the cells to produce ECM compositions with enhanced regenerative properties and reduced immunogenicity, directly addressing the contradiction between long-term effectiveness and immunogenic reactions
Solution Approach 2:
The patent creates composite ECM compositions that include multiple growth factors (VEGF, Wnt proteins) and embryonic proteins produced by hypoxically-cultured cells. This composite material approach combines multiple beneficial components that work synergistically to provide both immediate tissue augmentation and long-term regenerative effects while minimizing immunogenic responses
2Reliability
If xenogeneic collagens are used for soft tissue repair, then tissue augmentation is achieved, but production complexity and cost increase to remove immunogenic substances
Solution Approach 1:
The patent employs self-service by using autologous cells (cells from the patient's own body) to produce the ECM compositions. This eliminates the need for complex production processes to remove immunogenic substances from xenogeneic collagens, as the patient's own cells inherently produce biocompatible materials. The hypoxic culture condition enhances this self-service capability by inducing production of regenerative growth factors
Solution Approach 2:
The patent utilizes a disposable cell culture system where cells are cultured under hypoxic conditions to produce ECM compositions, which are then applied and allow natural degradation and regeneration. This approach avoids the complex, expensive production and purification processes required for xenogeneic collagens, replacing them with a simpler, more cost-effective cellular manufacturing approach
3Productivity
If standard atmospheric oxygen conditions are used for cell culture, then production is simplified, but growth factor production and gene expression are reduced
Solution Approach 1:
The patent applies parameter changes by modifying the oxygen tension parameter in the cell culture environment from standard atmospheric levels (21% oxygen) to hypoxic conditions (lower oxygen levels). This parameter change triggers significant increases in the expression of growth factors such as VEGF and Wnt proteins, as well as enhanced gene expression of embryonic proteins, directly improving productivity despite adding culture condition complexity
Solution Approach 2:
The patent implements preliminary action by pre-culturing cells under hypoxic conditions before harvesting the ECM compositions. This preliminary hypoxic exposure primes the cells to produce higher concentrations of regenerative growth factors and embryonic proteins, ensuring that the final product has enhanced therapeutic efficacy for tissue repair and regeneration applications
Data Source
AI summary
The present invention is directed to a method of producing compositions including embryonic proteins. The method includes culturing cells under hypoxic conditions on a biocompatible surface in vitro. The culturing method produces both soluble and non-soluble fractions, which may be used separately or in combination to obtain physiologically acceptable compositions useful in a variety of medical and therapeutic applications.