NIH Suspends New Embryonic Stem Cell Line Submissions

The National Institutes of Health (NIH) announced on Friday a new NIH Request for Information (RFI). It seeks public comment on the robustness of emerging biotechnologies.

These biotechnologies aim to reduce or potentially replace remaining research reliance on human embryonic stem cells. These stem cells are derived from human embryos.

The goal of the RFI is to identify research areas. In these areas, human embryonic stem cells are no longer needed. This change is due to new technological developments with better effectiveness.

This refers to research areas focusing on the robustness of emerging biotechnologies. These include induced pluripotent stem cells and currently approved adult stem cells. They can replace the use of human embryonic stem cell lines. Additionally, it involves areas where more investments should be made to bolster validated alternative models. Responses to the RFI will be accepted through April 24, 2026.

During this review, NIH is pausing review and approval of applications for new human embryonic stem cell lines to be added to the NIH Human Embryonic Stem Cell Registry.

Currently, 503 human embryonic stem cell lines have been approved for NIH-supported research. The biomedical research landscape has greatly evolved since the NIH Guidelines for Stem Cell Research were established in 2009. There has been a decline in the number of cell lines submitted for review to be added to the NIH Registry, with the last approved cell line added in December 2023.

“NIH is leading with gold-standard science that delivers better results for patients,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “As new technologies prove more effective, we have a responsibility to move beyond practices becoming obsolete and invest in more promising alternatives.”

“Over the past 20 years, induced pluripotent stem cells and adult stem cells have proven to be flexible and useful across biomedical research and therapy,”said Health and Human Services Deputy Secretary Jim O’Neil. “The American people deserve better alternatives to human embryonic stem cells.”

“This Request for Information seeks public input as NIH assesses the current and future utility of human embryonic stem cells in biomedical research and evaluates emerging alternatives, during a temporary pause in the review and approval of new human embryonic stem cell lines for inclusion in the NIH Registry,” said NIH Director Jay Bhattacharya, M.D., Ph.D.

Previously approved human embryonic stem cell lines listed on the NIH Human Embryonic Stem Cell Registry may continue to be used in NIH-funded research. The derivation of human embryonic stem cell lines from human embryos continues to be prohibited in NIH-supported research.