Cryopreserved RPE Cell Composition for Post-Thaw Administration
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Solution Overview
Problem
The practical limitations of using human fetal and adult RPE cells for transplantation include limited tissue supply, ethical concerns, and the need for immediate administration after thawing, which complicates widespread clinical use due to logistical constraints and cell viability issues.
Innovation Solution
Development of a ready-to-administer (RTA) retinal pigment epithelium (RPE) cell therapy composition using a cryopreservation media comprising DMSO, adenosine, dextran-40, and HEPES, allowing for formulation and administration directly after thawing, which maintains cell viability and functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If human fetal and adult RPE cells are used as donor sources for transplantation, then authentic functional RPE cells can be obtained, but tissue supply is limited and ethical concerns arise
Solution Approach 1:
The patent changes the source parameter from finite adult/fetal tissues to infinite pluripotent stem cells, and changes the state parameter by developing cryopreservation media that allows cells to be stored and administered after thawing, thus resolving both the quantity limitation and the immediacy requirement
Solution Approach 2:
The patent performs preliminary cryopreservation of RPE cells derived from pluripotent stem cells, allowing them to be stored in advance and administered after thawing without requiring immediate use, thus resolving the logistical constraints while maintaining cell viability
2Duration of action of stationary object
If RPE cells are preserved frozen in cryo-solution, then long-term storage is enabled, but the cryo-solution is not compatible with direct administration into the body
Solution Approach 1:
The patent extracts the harmful cryoprotectants from the final administration formulation by using a two-step process: first freezing cells in cryo-solution for storage, then washing them to remove toxic residues before administration, thus enabling both long-term storage and safe administration
Solution Approach 2:
The patent uses a washing step as an intermediary process between cryopreservation and administration, removing harmful substances while preserving cell viability, thus resolving the contradiction between storage capability and administration safety
3Reliability
If cells are transplanted within hours after thawing, then cell viability is maintained, but logistical flexibility is reduced due to the need for immediate administration
Solution Approach 1:
The patent performs preliminary cryopreservation to enable long-term storage, and through optimized thawing and washing protocols, extends the viable administration window beyond hours to days, thus resolving both the viability requirement and the logistical flexibility need
Solution Approach 2:
The patent develops self-contained cryopreserved cell products that maintain viability without requiring immediate complex processing, allowing hospitals to store and administer cells on-demand without specialized cell preparation facilities, thus improving logistical flexibility while maintaining viability
4Reliability
If RPE cells are prepared in certified facilities, then quality control is ensured, but facilities may not be in close proximity to clinical sites
Solution Approach 1:
The patent performs all quality control and cell preparation in advance at certified facilities during manufacturing, creating ready-to-administer cryopreserved products that can be shipped and stored at hospitals without requiring local cell preparation capabilities, thus resolving both quality control and accessibility requirements
Solution Approach 2:
The patent uses cryopreserved cell products as intermediaries that bridge the gap between centralized certified manufacturing facilities and distributed clinical sites, allowing quality-controlled cells to be transported and stored without specialized facilities at the point of care
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 RTA composition ensures high cell viability and functionality post-thawing, enabling effective treatment of retinal degenerative diseases with improved logistical flexibility and reduced ethical concerns.
Implementation Method 1
ready to administer (RTA) retinal pigment epithelium (RPE) cell therapy compositions... formulated for cryopreservation and administration of the cryopreserved composition to a subject subsequent to thawing
Data Source
AI summary
Presented herein are ready to administer (RTA) retinal pigment epithelium (RPE) cell therapy compositions for the treatment of retinal degenerative diseases and injuries. A method of formulating human RPE cells for administration to a subject directly after thawing and of formulating RPE cell therapy compositions for cryopreservation and administration of the cryopreserved composition to a subject subsequent to thawing are also presented. In another aspect, the RTA composition may be formulated as a thaw and inject (TAI) composition, whereby the composition is administered by injection subsequent to thawing.