Self-Renewing Colony-Forming Somatic Cells for Tissue Repair
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Solution Overview
Problem
Current cell-based therapies for tissue damage and degenerative conditions, particularly in neurological and cardiac tissues, face challenges such as limited regenerative capacity, variability in cell product consistency, and long-term engraftment requirements, which hinder effective treatment of conditions like spinal cord injuries, Parkinson's disease, and heart diseases.
Innovation Solution
The development of stable, in vitro cultured self-renewing colony-forming somatic cells (CF-SC) and extensively expanded CF-SC (exCF-SC) that maintain substantial self-renewal capacity and lack multipotent differentiation, which are administered without long-term engraftment, using pharmaceutically acceptable carriers to modulate the production of therapeutically useful compositions for tissue repair and regeneration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If autologous cells are used for cell-based therapy, then patient-specific treatment is achieved, but manufacturing complexity and time delay increase due to patient-by-patient basis production
Solution Approach 1:
The patent uses allogeneic cells as a copy or substitute for autologous cells, creating a standardized cell product that can be manufactured once and used for multiple patients. This eliminates the need for individualized cell manufacturing while providing consistent therapeutic effect through the use of healthy donor cells that can be banked and distributed widely.
2Adaptability or versatility
If autologous cells are used for cell-based therapy, then patient-specific treatment is achieved, but treatment time delay increases due to lag time between clinical decision and cell availability
Solution Approach 1:
The patent prepares allogeneic cell products in advance before clinical need arises, allowing cells to be manufactured, quality-tested, and banked ready for immediate use. This preliminary manufacturing and banking of healthy donor cells eliminates the time delay that would otherwise occur while waiting for patient-specific cell collection, processing, and validation.
3Manufacturing precision
If allogeneic cells are used for cell-based therapy, then manufacturing consistency improves, but donor variability risk increases
Solution Approach 1:
The patent carefully controls and standardizes multiple parameters of the allogeneic cell manufacturing process, including donor selection criteria, culture conditions, passage numbers, and storage parameters. By establishing strict parameter ranges and quality specifications, the patent ensures consistent cell product characteristics while minimizing the impact of donor variability through standardized processing protocols.
4Productivity
If extensively expanded CF-SC are used for therapy, then cell product availability improves, but cell differentiation capacity may be reduced
Solution Approach 1:
The patent extracts and utilizes only the secreted factors and trophic support properties of extensively expanded CF-SC, rather than relying on their differentiation capacity. By focusing on the paracrine effects and secretome of the cells, the patent can use highly expanded cell populations that have lost multipotent capacity but retain abundant secretory activity, thereby achieving both high productivity and therapeutic effect.
Data Source
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AI summary
The present invention relates to methods and uses of cells for the prevention and treatment of a wide variety of diseases and disorders and the repair and regeneration of tissues and organs using low passage and extensively passaged in vitro cultured, self- renewing, colony forming somatic cells (CF-SC). For example, adult bone marrow-derived somatic cells (ABM-SC), or compositions produced by such cells, are useful alone or in combination with other components for treating, for example, cardiovascular, neurological, integumentary, dermatological, periodontal, and immune mediated diseases, disorders, pathologies, and injuries.