Autologous Bone Marrow Cell Dosage via Phenotypic Screening
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Solution Overview
Problem
Current autologous tissue therapies for cardiovascular diseases face challenges in standardizing dosages due to variations in patient-specific cell potency and delivery efficiency, leading to inconsistent therapeutic outcomes and high costs associated with extensive cell manipulation and separate manufacturing lots for each patient.
Innovation Solution
The method involves selecting patients based on phenotypic profiles of their bone marrow cells, specifically assessing CD markers like CD34, CD133, and CD19, to determine suitability for transplantation and ensuring effective dosages are delivered through minimally processed autologous bone marrow cells using point-of-care systems for concentration and delivery, reducing processing complexity and costs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If extensive cell manipulation and separate manufacturing lots are used for each patient, then therapeutic potency can be optimized, but manufacturing complexity and costs increase significantly
Solution Approach 1:
The patent segments the cell therapy approach by using patient-specific bone marrow cell populations with defined phenotypic characteristics (CD markers) rather than creating completely separate manufacturing lots for each patient. This allows optimization of therapeutic potency through phenotypic selection while reducing manufacturing complexity by using a standardized processing framework.
Solution Approach 2:
The patent changes the parameter of cell selection from traditional quantitative dosage approaches to phenotypic characterization using CD markers (CD34, CD133, CD19). This enables standardized manufacturing processes to produce cell products with consistent biological activity across different patients, reducing manufacturing complexity while maintaining therapeutic efficacy.
2Reliability
If patient-specific cell dosing is customized based on individual cell potency, then therapeutic efficacy is improved, but measurement and dosing complexity increase
Solution Approach 1:
The patent replaces complex mechanical cell counting and potency assays with immunophenotypic measurement using CD markers. This substitution simplifies the measurement process while maintaining the ability to customize dosing based on individual cell characteristics, as the phenotypic profile provides a direct measure of cell quality that guides dosage selection.
3Adaptability or versatility
If traditional autologous cell therapy processing is used, then patient-specific treatment is achieved, but processing time and costs increase
Solution Approach 1:
The patent applies preliminary action by pre-defining the phenotypic characteristics and CD marker profiles that identify suitable bone marrow cell populations before the actual cell processing. This allows for rapid identification and selection of appropriate cell products during patient treatment, reducing processing time while maintaining patient-specific customization based on individual phenotypic profiles.
Data Source
AI summary
Autologous bone marrow cells (BMC) are transplanted to a heterologous site in a patient after a sample of the patient's BMC has been tested and found to have a phenotypic profile which meets minimum criteria for transplantation. The phenotypic profile may be obtained by screening a sample of bone marrow cells (BMC) from the patient for the phenotypic profile, such as a CD profile, the phenotype profile may be assessed to determine the likelihood that the BMC will be suitable for transplantation to the heterologous tissue site without enriching particular phenotypic population(s) of the BMC.