ArticleScientific reports2015
Ultra-sensitive detection of tumorigenic cellular impurities in human cell-processed therapeutic products by digital analysis of soft agar colony formation.
Article in Scientific reports, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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Who cites it
23 citing papers in PubMed, 53 citations in OpenAlex.
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- Standard Methods for Quality Control in Cell-Based Medicinal Products and their Validation for Clinical Applications.Advanced biomedical research · 2026Review
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- Development of Animal Models for Preclinical Safety Studies.Advances in experimental medicine and biology · 2025Review
- Review of hTERT-Immortalized Cells: How to Assess Immortality and Confirm Identity.International journal of molecular sciences · 2024Review
- Expanding a precision medicine platform for malignant peripheral nerve sheath tumors: New patient-derived orthotopic xenografts, cell lines and tumor entities.Molecular oncology · 2024Article
- Cryopreserved cGMP-compliant human pluripotent stem cell-derived hepatic progenitors rescue mice from acute liver failure through rapid paracrine effects on liver cells.Stem cell research & therapy · 2024Article
- A novel patient-derived immortalised cell line of myxofibrosarcoma: a tool for preclinical drugs testing and the generation of near-patient models.BMC cancer · 2023Article
- Assessing Tumorigenicity in Stem Cell-Derived Therapeutic Products: A Critical Step in Safeguarding Regenerative Medicine.Bioengineering (Basel, Switzerland) · 2023Review
- The evaluation of tumorigenicity and characterization of colonies in a soft agar colony formation assay using polymerase chain reaction.Scientific reports · 2023Article
- Evaluation of the reproducibility and positive controls of cellular immortality test for the detection of immortalized cellular impurities in human cell-processed therapeutic products.Regenerative therapy · 2022Article
- The Anterior Eye Chamber as a Visible Medium for In Vivo Tumorigenicity Tests.Stem cells translational medicine · 2022Article
- Safety study of allogeneic mesenchymal stem cell therapy in animal model.Regenerative therapy · 2022Article
- Evaluation of twoMolecular therapy. Methods & clinical development · 2021Article
- Transplantation of human autologous synovial mesenchymal stem cells with trisomy 7 into the knee joint and 5 years of follow-up.Stem cells translational medicine · 2021Article
- Transient induction of telomerase expression mediates senescence and reduces tumorigenesis in primary fibroblasts.Proceedings of the National Academy of Sciences of the United States of America · 2019Article
Corrections and comments
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Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Contamination with tumorigenic cellular impurities is one of the most pressing concerns for human cell-processed therapeutic products (hCTPs). The soft agar colony formation (SACF) assay, which is a well-known in vitro assay for the detection of malignant transformed cells, is applicable for the quality assessment of hCTPs. Here we established an image-based screening system for the SACF assay using a high-content cell analyzer termed the digital SACF assay. Dual fluorescence staining of formed colonies and the dissolution of soft agar led to accurate detection of transformed cells with the imaging cytometer. Partitioning a cell sample into multiple wells of culture plates enabled digital readout of the presence of colonies and elevated the sensitivity for their detection. In practice, the digital SACF assay detected impurity levels as low as 0.00001% of the hCTPs, i.e. only one HeLa cell contained in 10,000,000 human mesenchymal stem cells, within 30 days. The digital SACF assay saves time, is more sensitive than in vivo tumorigenicity tests, and would be useful for the quality control of hCTPs in the manufacturing process.
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