Bedside Closed-Loop System for In Vivo Cell Modification
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Solution Overview
Problem
Current cell therapeutic approaches require ex vivo expansion and manipulation of cells, which are costly, risky, and inefficient, and often necessitate offline processing and re-introduction of cells, increasing the risk of contamination and reducing patient safety.
Innovation Solution
A bedside, closed-loop system for continuous-flow cell modification that integrates cell separation, customization, and return to the patient, allowing for real-time customization of nucleated blood cells, such as CAR-T cells, without the need for ex vivo expansion, using modules like cell separation, customization, and detection to ensure precise delivery of modifying agents and monitoring of cell thresholds.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ex vivo expansion and manipulation of cells is performed, then cell therapeutic outcomes can be achieved, but operational costs increase and patient safety decreases
Solution Approach 1:
The patent extracts the cell modification step from the traditional ex vivo process and performs it in vivo through targeted delivery of modifying agents (e.g., viral vectors, CRISPR components) directly to the patient's cells, eliminating the need for cell collection, expansion, and manipulation in external laboratories
Solution Approach 2:
The patient's body serves as the bioreactor where cells are automatically collected, modified through delivered agents, expanded, and re-infused without external intervention, making the system self-sufficient and reducing operational complexity
2Reliability
If ex vivo cell processing is performed, then cell customization is achieved, but contamination risks increase
Solution Approach 1:
The patent removes cells from the external processing environment and keeps them in vivo throughout the modification process, extracting only the necessary modifying agents into the patient's body where modification occurs in a sterile, controlled physiological environment
Solution Approach 2:
The patient's body provides a naturally sterile, controlled environment that protects cells from contamination during modification, eliminating the need for complex sterile processing facilities and reducing contamination risks inherent in external laboratories
3Loss of time
If offline cell manipulation is performed, then cell therapy can be delivered, but treatment time increases
Solution Approach 1:
The patent enables continuous in vivo cell modification and expansion without interruption, allowing cells to be modified and expanded simultaneously in the patient's body rather than requiring sequential offline processing steps that extend treatment time
Solution Approach 2:
The modifying agents are delivered to the patient's cells in advance, initiating the modification and expansion process before full therapeutic effect is needed, allowing the body to naturally perform the time-consuming expansion process in a controlled manner
Data Source
AI summary
Provided herein are bedside systems and methods for performing customized cell-based therapies and treatments in a patient-connected, closed-loop continuous-flow manner, including cellular modifications and treatments, e.g., to produce chimeric antigen receptor-T (CAR-T) cells among other cellular modifications and treatments.