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FailSafe Cells
- Development stage
- Preclinical
- Lead developer
- panCELLa
- Modality
- Gene Therapies, iPSCs → Pluripotent Stem Cells → Stem Cell Therapies → Cell Therapies
- Administration
- Intravenous, Intrathecal, Intramuscular
01
Overview
FailSafe Cells (also known as FailSafe®) is a genetically engineered cell therapy safety platform developed by panCELLa and commercialized through Pluristyx. The technology is designed to address the risk of tumor formation (teratomas) in stem cell-based therapies by incorporating a suicide gene safety switch. It works by linking the herpes simplex virus thymidine kinase (HSV-TK) suicide gene to the cyclin-dependent kinase 1 (CDK1) locus, which is essential for cell division. This linkage ensures that the suicide gene is expressed in all dividing cells. When the FDA-approved prodrug ganciclovir (GCV) is administered, it is converted by HSV-TK into a toxic metabolite that selectively eliminates proliferating cells (such as undifferentiated iPSCs or potential tumor cells) while leaving non-dividing, terminally differentiated therapeutic cells intact. The platform is intended for use in regenerative medicine for conditions such as diabetes, cancer, stroke, and spinal cord injury.
- Brand names
- FailSafePluriBank
- Other names
- FailSafe technologyFailSafe system
02
Targets
HSV-TK (Herpes simplex virus type 1 thymidine kinase (HSV1-TK))
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