B Regulatory Cell Quantification for Stem Cell Therapy Response Prediction

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Solution Overview

Problem

Stem cell therapeutics, particularly mesenchymal stem cells, show reduced efficacy in advanced clinical trials due to variability and the need for predicting responsiveness to therapy.

Innovation Solution

The method involves identifying and quantifying B regulatory cells, specifically CD1dhighCD5+ cells capable of producing IL-10, to assess the responsiveness to mesenchymal stem cell therapy, using monoclonal antibodies and flow cytometry for cell selection and purification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If stem cell therapy is administered to treat diverse diseases, then therapeutic potential is improved, but variability in clinical trial results increases

Engineering Contradiction:

Improvetherapeutic efficacyVSAvoidresponse variability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent applies preliminary action by measuring B regulatory cell levels before stem cell therapy administration to predict treatment responsiveness. This pre-assessment allows clinicians to identify patients likely to respond favorably before undergoing therapy, thereby reducing the variability in clinical outcomes and improving overall therapeutic reliability.

Inventive Principle:

Principle #10Preliminary action

2Ease of operation

If mesenchymal stem cells are used for therapy, then ease of transplantation is improved, but predictability of treatment response deteriorates

Engineering Contradiction:

Improvetransplantation easeVSAvoidresponse prediction accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent introduces B regulatory cells as an intermediary biomarker to predict stem cell therapy response. By measuring this intermediate biological factor before treatment, the system bridges the gap between the simple act of transplantation and the complex outcome of treatment efficacy, enabling accurate prediction without complicating the transplantation procedure itself.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Productivity

If stem cell therapy is expanded to advanced clinical trials, then treatment accessibility is improved, but therapeutic advantage over placebo decreases

Engineering Contradiction:

Improvetreatment accessibilityVSAvoidtherapeutic advantage

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent applies preliminary action by implementing B regulatory cell measurement in advanced clinical trials to pre-identify responsive patients. This allows for more precise patient selection in large-scale studies, ensuring that only those likely to benefit receive active treatment, thereby maintaining therapeutic advantage over placebo even as trial accessibility expands.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20240241119A1Prediction of stem cell therapy responsiveness by quantification of pre-existing b regulatory cells

Publication Date: 2024.07.18 THERAPEUTIC SOLUTIONS INTERNATIONAL INC

AI summary

Disclosed are novel means of stratifying patients into potential of positive response to mesenchymal stem cell therapy based on quantification of pretreatment levels of B regulatory cells. In one embodiment quantification of cells concurrently expressing CD5 and CD19. In another embodiment B regulatory cells are CD19+CD39−IL10+. In one embodiment the selection of B regulatory cells is quantified by flow cytometric means and patients possessing more than 7% IL-10 secreting CD19 cells are chosen for stem cell therapy. In some embodiments numbers of B regulatory cells are increased prior to treatment by administration of various interventions including providing GM-CSF, microbiome alteration or manipulation of oxidative stress.