Federal Policy Allows Funding for New Human Embryonic Stem Cell Lines
But Not All Investigators are Happy with the Changes
ARTICLE IN BRIEF
Forty new human embryonic stem cell lines have been approved for NIH funding since the Obama administration reversed an earlier policy by the Bush Administration. But some investigators are concerned about the impact the new guidelines will have on work developed before August 2001.
Five months after the NIH created new guidelines for human embryonic stem cell research — a roadmap that would provide federal funding to work on stem cells donated by women undergoing in vitro fertilization (IVF) — the first 13 lines made it to the laboratory shelf. Two weeks later, in early December, another 27 were approved. Others are set to follow.
As directed by the Obama administration, the NIH approval of new embryonic stem cell lines reversed an earlier policy by the Bush administration, which limited federal funding to lines developed before August 2001. The new lines added by NIH in December were actually developed between 2004 and 2007. The technology has improved and the hope is that newly created cell lines will be added to the registry.
To date, 27 of the 40 newly approved lines to date, all derived at Harvard's Stem Cell Institute, can only be used for research in diabetes. The reason, according to a number of stem cell researchers, is that the informed consent signed by the women undergoing IVF specifically made reference to the use of the embryos for research in diabetes.
“Even though I believe the next 27 lines will be used for diabetes research, this is the beginning of a process whereby new lines can be approved for use with NIH funds,” said Fred H. Gage, PhD, professor and Vi and John Adler Chair for Research on Age-Related Neurodegenerative Diseases at the Salk Institute for Biological Studies in La Jolla, CA, who works with embryonic stem cells. “I think that eventually it would be useful for the NIH to establish a cell repository or bank to standardize the quality control of the cells and assist in the equal and fair distribution of the cells.”
But some investigators have concerns with the new program in place to expand the use of stem cell research. Only a few of the 21 so-called Bush lines have been re-submitted for approval and that means that much of the work done in the past decade will not move forward.
For instance, Lorenz Studer, MD, director of the Laboratory of Stem Cell & Tumor Biology, Neurosurgery and Developmental Biology, and his colleagues at Memorial Sloan Kettering Cancer Center are making dopamine cells that are specific to the mid-brain. They used one of the first stem cell lines to be approved under Bush. They were derived at the University of Wisconsin but the embryonic material originated from scientists in Israel.
Dr. Studer and his colleagues spent years tweaking this cell line to develop two dozen new cell lines that basically represent various stages in the life of a dopamine neuron. The hope is to figure out which cell lines would work best in animal models of Parkinson disease and, eventually, to treat human disease.
But as it stands now, the starter cell line — called HA-9 — has not been submitted to the NIH registry for approval. So Dr. Studer technically can't use federal money to continue working on the cell lines he developed.
“Each line takes six months to create,” he noted. “It is a unique resource.”
Dr. Studer is about to submit a grant to the NIH to continue the study but has been told that he can't use cell lines that are not in the registry. “It is a sad state of affairs,” he said. “We may have to use non-federal funding sources to continue doing the research.”
There are similar stories in stem cell labs all over the country.
On the other hand, Scott Noggle, PhD, director of the NY Stem Cell Foundation laboratory — a private organization that has a strong research and public advocacy arm — made two of the 13 of the newly accepted cell lines as a post-doctoral student at Rockefeller University under the direction of Ali Brivanlou, PhD. Investigators at Rockefeller are using the two new lines to study human embryonic stem cells in peripheral nerve dysfunction, multiple sclerosis, as well as for motoneurons for transplantation in animal models of amyotrophic lateral sclerosis.
“When President Obama spoke so powerfully last March about returning science to its rightful place in establishing our national priorities and policies, we were all relieved and optimistic about the future,” said Douglas Melton, PhD, co-director of the Harvard Stem Cell Institute.
“In the intervening period the NIH has proceeded with a deliberative process and come to a compromise solution on what cell lines it believes should be eligible for funding,” Dr. Melton continued. “Their choices are not entirely aligned with the equally careful and deliberative processes used by Harvard University's Embryonic Stem Cell Research Oversight Committee and independent institutional review boards [IRBs] over the last eight years, but I understand that political considerations and changes in public perception influenced the NIH decisions. Thus, while the new policy is not what I expected after hearing the President's speech, it is a significant improvement and a cause for celebration among scientists and patients.”
“We are very happy about this effort,” said Susan Solomon, co-founder and chief executive officer of the New York Stem Cell Foundation But she agreed with Dr. Melton that more work will have to be done. “We thought they would say that any line submitted and approved by a recognized IRB would be accepted and made available for research,” she said. “They didn't do that. The problem is that IRB consent standards vary from institute to institute and everybody will have to change the way they do things.” Scientists will now have to submit their cell lines for approval to the NIH Human Embryonic Stem Cell Registry. Issues and concerns about the quality of the informed consent (used in the collection of donated embryos) or the cell lines will be addressed by a federally appointed working group implemented by NIH Director Francis S. Collins, MD, PhD.
The new guidelines are available at http://stemcells.nih.gov/policy/2009guidelines.htm. To see the list of federally approved human ES cell lines go to: http://grants.nih.gov/stem_cells/registry/current.htm.