Placental Stem Cell Formulation with Dextran and HSA
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Solution Overview
Problem
Current cell compositions, particularly stem cell compositions, face challenges in formulation and administration due to issues like post-thaw clumping, which affects their efficacy and safety for therapeutic use.
Innovation Solution
The development of improved methods for making compositions involving placental cells, including specific steps for pre-cryopreservation treatment, cryopreservation, and thawing, using solutions with dextran and human serum albumin (HSA) to reduce or eliminate post-thaw clumping, and diluting cell concentrations to optimal levels for administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If cells are cryopreserved using conventional methods, then cell storage is achieved, but post-thaw clumping occurs reducing efficacy and safety
Solution Approach 1:
The patent applies preliminary action by pre-coating filtration devices with human serum albumin (HSA) before cell processing. This pre-treatment prevents cell clumping during subsequent filtration and cryopreservation steps, eliminating the harmful effect before it can occur during the main process
Solution Approach 2:
The patent uses human serum albumin (HSA) as an intermediary substance that coats the filtration device surface, creating a protective barrier between cells and the device surface. This intermediary layer prevents direct cell-device interaction that would cause clumping, while allowing cells to pass through freely
2Ease of manufacture
If cell concentration is not controlled, then processing is simplified, but administration safety and effectiveness are compromised
Solution Approach 1:
The patent incorporates feedback by measuring cell concentration after filtration and using this information to determine subsequent dilution requirements. The system automatically adjusts dilution volume based on actual cell count, ensuring target concentration is achieved while maintaining process simplicity
Solution Approach 2:
The patent applies parameter changes by adjusting cell concentration through controlled dilution with culture medium. The cell concentration parameter is modified from the post-filtration value to the target administration value, ensuring safety and effectiveness while maintaining flexible processing
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The methods result in cell compositions that are better tolerated and more effective, with reduced cell clumps, enhancing their therapeutic potential and safety for administration.
Implementation Method 1
The improved methods use specific steps and specific compositions for the pre-cryopreservation treatment, cryopreservation, and thawing of cells
Implementation Method 2
contacting cells with a solution comprising dextran and human serum albumin (HSA) to form a cell-containing solution
Implementation Method 3
filtering the cell-containing solution to form a filtered cell-containing solution
Implementation Method 4
optionally diluting the filtered cell-containing solution to about 1 to 50×10^6, 1 to 40×10^6, 1 to 30×10^6, 1 to 20×10^6, 1 to 15×10^6, or 1 to 10×10^6 cells per milliliter
Data Source
AI summary
Provided herein are improved methods for the formulation of compositions comprising placental stem cells, and improved compositions and cell formulations produced thereby.