Human Tissue Constructs for Newborn Vaccine Evaluation
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Solution Overview
Problem
Current tissue engineering systems for vaccine evaluation do not account for age-dependent changes in immunity, particularly in newborns, and use xenologous materials that do not reflect the immunomodulatory components unique to human autologous plasma, making them unsuitable for assessing vaccine safety and efficacy in newborns.
Innovation Solution
Development of human tissue constructs composed largely or entirely of human materials, using primary leukocytes from cord blood, intact human newborn plasma, and platelet-poor plasma to create a three-dimensional system that recapitulates the immune cells and immune system of newborns and adults, allowing for the evaluation of vaccine formulations, immunomodulators, and adjuvants in a pre-clinical in vitro setting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If xenologous materials such as fetal bovine serum are used in tissue engineering systems, then the system can be established and operated, but the system does not reflect the immunomodulatory components unique to human autologous plasma, reducing measurement precision for newborn vaccine evaluation
Solution Approach 1:
The patent changes the composition parameters of the culture medium by replacing xenologous serum with human autologous plasma, specifically using plasma from the same age group (newborn, infant, child, or adult) as the cells being cultured. This parameter change ensures that the immunomodulatory components in the plasma match the physiological conditions of the target population, thereby improving both reliability and measurement precision of vaccine evaluation.
Solution Approach 2:
The patent applies local quality by matching the plasma source to the specific age group being studied. Instead of using a universal plasma source, the system uses age-specific plasma (newborn plasma for newborn cells, adult plasma for adult cells), creating locally optimized conditions that reflect the unique immunological characteristics of each age group.
2Reliability
If heat-treated pooled human serum is used in tissue engineering systems, then the system can be established, but the immunomodulatory components unique to intact autologous plasma are lost, reducing reliability for assessing vaccine safety and efficacy
Solution Approach 1:
The patent applies preliminary action by preparing and storing intact human autologous plasma before it is needed for the tissue engineering system. The plasma is collected, processed to remove cells and debris, and stored under controlled conditions to preserve its immunomodulatory components. This preliminary preparation ensures that the plasma is ready for use without requiring heat treatment that would degrade its functional components.
3Ease of operation
If adult tissue engineering systems are used for newborn vaccine evaluation, then the system can be operated, but age-dependent changes in immunity are not accounted for, reducing measurement precision
Solution Approach 1:
The patent changes the physiological parameters of the tissue engineering system by using newborn-specific plasma and newborn mononuclear cells instead of adult counterparts. This creates a neonatal-specific tissue engineering system that operates under conditions reflecting newborn physiology, including appropriate levels of complement, adenosine, and other immunomodulatory factors that differ from adult systems.
Data Source
AI summary
Artificial tissue constructs (TCs), methods of making the TCs, uses thereof, and kits comprising the TCs are provided. TCs are useful for vaccine evaluation for human adult, human non-newborn, and newborns.