Testing a new method to predict developmental toxicity using human stem cells
Official title: DDT-BMQ-000109, Qualification of biomarkers for in vitro developmental toxicity screening in a human system
Funded at Stemina Biomarker Discovery, INC. · NIH-10836889 · Data updated 2026-11-12
This study is testing a new way to check if certain drugs might harm development in babies by looking at specific markers in human stem cells, which could help make drug development safer for everyone.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Stemina Biomarker Discovery, INC. NIH-funded |
| Lab location | 1 site (Madison, United States) |
| Project start | September 15, 2023 |
| Project end | June 30, 2025 |
| Funding year | 2023 |
| Award (this year) | $249,943 |
| NIH project number | 1U01FD008132-01 |
| Project ID | NIH-10836889 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are individuals involved in drug development processes, particularly those concerned with the safety of new medications.
✕Less likely to help
Patients who are not involved in drug development or who do not have concerns about developmental toxicity may not receive direct benefits from this research.
What this research studies
This research investigates a novel assay called devTOX quickPredict, which utilizes human pluripotent stem cells to assess the potential for compounds to cause developmental toxicity. By measuring the ratio of two biomarkers, ornithine and cystine, the study aims to qualify this method as a reliable safety indicator during the early stages of drug development. The research involves validating the analytical methods used to measure these biomarkers to ensure accuracy and reliability. Patients may benefit from safer drug development processes that minimize risks of developmental toxicity.
Why it matters
Potential benefit: If successful, this research could lead to safer drug development practices, reducing the risk of developmental toxicity in new medications.
How similar studies have gone: While this approach is innovative, similar methodologies have shown promise in other contexts, indicating potential for success.
Where this research is happening
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Stemina Biomarker Discovery, INC.
Madison, United States Active
Researchers
- Principal investigator: Palmer, Jessica a — Stemina Biomarker Discovery, INC.
- Study coordinator: Palmer, Jessica a
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.