FailSafe®
A safety switch designed for cell therapy.
Our FailSafe® Mechanism for Cell Therapy
Induced pluripotent stem cells (iPSCs) are a paradigm-shifting effect on the field of cell therapy and regenerative medicine. Stem cells offer a powerful new treatment against diseases underlined by cell loss, tissue degeneration and aging.
With these applications came critical and important challenges: uncontrolled proliferation without control; genetic mutations; and, other safety risks for patients. Our FailSafe® technology offers an ideal solution: all transplanted cells and their derivatives that are proliferating can easily be eliminated with our “suicide switch” safeguard by treating the patient with a drug instead of surgery.
The FailSafe® technology means to quantify the safety level of a prospective cell therapy.
Our panCELLa Platform's exclusive FailSafe® uses a suicide gene (HSV-TK) and an FDA-approved prodrug (Gancivlovir).
A therapeutic batch of cells are considered FailSafe® if all of the cells are engineered to have a functional suicide switch.
We Have a Solution: The FailSafe® Cell System
The FailSafe® cell system is designed to address the need for a reliable expression of the suicide gene in cell-based therapies. To achieve this, FailSafe® links the expression of a drug-inducible suicide gene to a gene absolutely essential for cell division (CDEL) in a homozygous manner. This ensures that if the cell is dividing, it will be compelled to express the suicide gene.
What sets FailSafe® apart is its unparalleled reliability for stem cell transplants. Through a homozygous link, both alleles of the CDEL carry the safety switch, leaving no room for escape. The system also allows assessing and quantifying the safety of cell therapy treatments, which is essential for informed decision-making by regulators, clinicians and patients while advancing toward modern cell-based medicine.
FailSafe® Engineered Stem Cells
Pluripotent stem cells engineered with FailSafe® are capable of differentiation into a multitude of potential therapeutic cell types such as pancreatic islets, mesenchymal stem cells and hematopoietic stem cells, showing that FailSafe® does not interfere with their functionality.
With a suicide gene placed into a locus essential for cell life, all the transplanted cells are eliminated regardless of their proliferative status. FailSafe® is unique in that, rather than kill all cells, it merely eliminates only actively dividing cells, ensuring that differentiated therapeutic cells are not accidentally killed off and can continue to provide benefit to patients.
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A groundbreaking technology that enables allograft transplantation without the need for systemic immune suppression
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REA Process & Licensing
Try Before You Buy
By offering the Research Evaluation Agreement you can gain access to our modified and non-modified cellular products for evaluation with our Try Before You Buy model. A smaller upfront payment limits your risk. Once you see the successful results, you can then enter into a license agreement with us panCELLa / Pluristyx.
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Human Pluripotent Stem Cells
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Human pluripotent stem cells (hPSC) for use in R&D activities. Inquire for GMP grade cells suitable as a starting material in clinical applications. All cell lines are registered with the U.S. National Institutes of Health (NIH), are listed in the NIH Human Stem Cell Registry and are eligible for use in NIH-funded research.
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iACT Stealth Cells™
A groundbreaking technology that enables allograft transplantation without the need for systemic immune suppression
Our groundbreaking iACT technology with immune-modulatory genes allows the acceptance of allografts without the need for systemic immune suppression. Equipping pluripotent stem cells with this technology will allow the same cell line to be used for differentiation and ultimately transplantation into any individual.
Learn More
REA Process & Licensing
Try Before You Buy
By offering the Research Evaluation Agreement you can gain access to our modified and non-modified cellular products for evaluation with our Try Before You Buy model. A smaller upfront payment limits your risk. Once you see the successful results, you can then enter into a license agreement with us panCELLa / Pluristyx.
Learn More
Human Pluripotent Stem Cells
Product
Human pluripotent stem cells (hPSC) for use in R&D activities. Inquire for GMP grade cells suitable as a starting material in clinical applications. All cell lines are registered with the U.S. National Institutes of Health (NIH), are listed in the NIH Human Stem Cell Registry and are eligible for use in NIH-funded research.
Shop Now