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Three (3) Stem Cell Lines Now on Hold by the NIH

Three (3) human embryonic stem cell lines once eligible (5/4/10) for federal funding are “on hold” until further notice because they were derived from embryos that were too early. “These lines were derived from early embryos — those consisting of 6, 8, or 16 cells and thus formally did not fit the official definition of ES cells by the NIH,” states George Daley, who derived these particular lines and submitted them for approval to the NIH last year. For the record, George Q. Daley, MD, PhD is Associate Professor of Pediatrics in the Division of Hematology/Oncology at the Children’s Hospital and Dana Farber Cancer Institute and Associate Professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School. Dr. Daley’s laboratory studies stem cell development and differentiation, emphasizing derivation of functional hematopoietic and germ cell elements from ES cells and the genetic mechanisms that predispose to malignancy.

The current definition is limited to “cells that are derived from the inner cell mass of blastocyst-stage human embryos” — a stage that the three lines on hold “failed to reach,” said an NIH spokesperson.

  • Last February, the NIH published a notice in the Federal Register (FR) that proposed a change in the formal definition of human embryonic stem cell to include such early embryos,

The issue of whether cell lines derived from early embryos could be approved for federal funding was initially raised when Advanced Cell Technology (ACT) submitted 5 stem cell lines similarly derived from early embryos to the NIH for inclusion.

  • The NIH declined to say how it was realized that the 3 already approved lines also fell outside of the official definition set forth by the NIH,
  • The proposed change had received public comment that is currently being considered by the NIH, during which time the lines — 3 of the first to be approved for federal funding under the new NIH guidelines — “should not be used in NIH-funded research,” according to the notice on the stem cell registry.  When asked about the impact of such a hold on current research using these lines, Daley said that the lines “are generic and people are using others.”

The NIH also declined to comment on how the lines were approved in the first place when they did not meet the formal definition in the new guidelines. (HWM and J Akst, The Scientist)

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