November 6, 2002, Summary
NIH Stem Cell Task Force
James Battey, NIDCD, (Chair); Arlene Chiu, NINDS; Greg Downing,OD/OSP; Pam Robey, NIDCR; Lana Skirboll, OD/OSP; Allen Spiegel, NIDDK; Richard Tasca, NICHD; John Thomas, NHLBI; Judith Vaitukaitis, NCRR
Barry Davis, NIDCD; Della Hann, OD/OER; Frank Holloman, PMI; Anne White-Olson, NIDCD; Baldwin Wong, NIDCD
Dr. Battey welcomed the members to the second meeting of the NIH Stem Cell Task Force and thanked them for their commitment of time.
II. Approval of September 20, 2002 Meeting Minutes
The Task Force approved the minutes of the September 20 meeting. The summary will be posted on the Task Force Web site at http://stemcells.nih.gov/policy/taskForce/tfSummaries/pages/09_20_02.aspx.
III. Follow-Up Issues from Previous Task Force Meeting
Dr. Battey announced the URL for the NIH Stem Cell Task Force as http://stemcells.nih.gov/policy/taskforce. The Web site also contains information about current NIH Funding Announcements (RFAs, PAs, etc.) related to stem cell research. Dr. Thomas suggested that there be a link from the NIH Stem Cell Web site to the Task Force Web site.
Dr. Vaitukaitis provided an update on the seven human embryonic stem cell infrastructure grants awarded by NCRR to UCSF, ES Cell International, WiCell, Cellsaurus, Technion, MizMedi, Karolinksa and Cythera. Dr. Skirboll inquired if there has been any feedback from the scientific community about the ease of growing the cells after receiving them from the providers. Dr. Vaitukaitis will ask the providers for this information. Dr. Hann suggested that it may be easier to obtain this information from NIH grantees than the providers. Dr. Battey suggested that the Program Announcement for the Infrastructure grants be reissued to provide an opportunity for the other providers on the NIH Stem Cell Registry to apply.
A discussion on whether NIH should create a special emphasis panel (SEP) to review stem cell grant applications was led by Dr. Battey. In his discussion with CSR, Dr. Ehrenfeld did not think it was necessary to have a SEP at this time because the low volume of grant applications do not justify the need, and the scope of stem cell biology is too broad to be covered under a single panel. Dr. Robey suggested including reviewers with expertise on study sections as an alternative, and Dr. Spiegel stated that stem cell grant applications are usually assigned to conventional cell biology study sections. There is also a shortage of stem cell reviewers, noted Dr. Downing. Dr. Skirboll noted that such research could also be funded under a task order contract.
Acknowledging the need to jump-start this field, the Task Force agreed that a temporary special CSR study section should be established, for one to two years, to review stem cell grant applications. Dr. Battey will contact Dr. Ehrenfeld with this suggestion.
IV. Policy Interpretation of Stem Cell Research and Chimeras
Dr. Skirboll alerted the Task Force about a research experiment recently published by a group in Israel where human embryonic stem (hES) cells were transplanted in chick embryos at the 12-20 somite stage, which is considered the beginning of organogenesis for chicks. Although the NIH Guidelines for Research Using Human Embryonic Stem Cells do not allow NIH funding for research in which hES cells are combined with an animal embryo, the authors of the research state that this experiment would be allowable for federal funding because it was not designed to create a chimera.
Dr. Skirboll asked the Task Force for guidance in developing policy for the research community on allowable activities using hES and animal embryos that would be eligible for federal funding. That is, at what stage could hES cells be combined with a developing animal and the researcher could be assured that a full chimera (germ line) would not be the result? It was suggested that an appropriate time frame in which to introduce hES may be after germ line specification. Dr. Tasca will survey members of the research community and colleagues at NICHD to determine what stage of embryogenesis is appropriate and for different species.
V. Research Resource Access Working Group
Dr. Battey announced that the Stem Cell Research Resource Access Working Group is scheduled to meet on December 10. The working group will identify the major obstacles in accessing the hES cells listed in the NIH Stem Cell Registry and develop suggestions for improving the availability and scale-up of the cell lines. Some members of the Task Force are participants of this working group and are preparing background information for the meeting.
VI. Stem Cell Research Career Pathways Working Group Suggestions
A basic requirement to starting any research field is developing a cadre of scientists. The Stem Cell Research Career Pathways Working Group convened on October 24, 2002, to discuss ways to train scientists in stem cell biology and increase researchers in this field. The Working Group developed several suggestions to address this need:
Support Multidisciplinary Centers
As a means to train scientists in stem cell biology, the Working Group suggested that NIH support multidisciplinary centers. These centers should conduct research across species, across tissues and/or across specific topical interests. The centers should also have a history of culturing embryonic stem cells and training scientists in this arena. Dr. Battey announced that NIGMS has an announcement for P20 exploratory centers which can mature to P50 specialized centers. Dr. Tasca also noted that the program project mechanism can also serve as a precursor to larger centers. Dr. Spiegel announced some of NIDDK's initiatives such as the Beta Cell Biology. He also suggested that administrative supplements could be used to allow scientists to be trained within different labs, which can be patterned similar to the minority or disability supplement programs. Dr. Battey acknowledged the examples of training activities being discussed by the Task Force and will also ask the ICs for additional examples of center training initiatives being supported.
Support High Risk/High Impact Research
The need for preliminary data is usually required before a researcher can apply for an R01. Because the field of human embryonic stem cell research is new, many scientists entering this field need federal funding to generate this data. The Working Group suggested that NIH support high risk/high impact research as a means to generate hES cell research. The Task Force acknowledged that the NIH utilizes the R21 mechanism to fund high risk/high impact research in many areas. Dr. Battey will ask the ICs for information on how this funding mechanism is being used by NIH to stimulate stem cell research. Dr. Vaitukaitis suggested that the R21 be supported at $100,000 per year.
Develop Uniform Stem Cell Characterization Methods
Dr. Battey announced the discussions he had with Dr. Gottesman and Dr. McKay about establishing a hES cell unit within NIH's Intramural Program to characterize the available hES cell lines in the NIH Stem Cell Registry. It is proposed that the unit be housed within the intramural program of NINDS, be a long-term shared resource at NIH, and be supported by funding from interested ICs as well as start-up funds from the Office of the Director. The unit can also develop standards for quality control for cell characterization. Dr. Hann inquired whether there are restrictions to any agreements between the NIH and the cell providers when NIH begins characterizing the cells. The NIH Office of Technology Transfer will be contacted for their guidance on this.
Another trans-NIH effort discussed by the Task Force was the need to develop monoclonal antibodies to surface markers on stem cells. Some ICs may be funding antibody facilities, which may be incorporated into the stem cell effort. Dr. Battey will ask the ICs for examples of ongoing or planned initiatives in this area.
Train Scientists on Stem Cell Biology
Human embryonic stem cells may be difficult to grow without the proper training. The Working Group suggested that NIH support the training of scientists interested in working with stem cells. It was noted that the T15 continuing education training grant will be one way to give scientists the opportunity to learn how to get the hES cells to grow and remain undifferentiated. Dr. Thomas described the T15 training grant that NIH is utilizing to meet this need. Five applications have been received, which supports up to $150,000 per year for one to three years. Dr. Thomas also announced that Technion will be collaborating with scientists from NIA to provide stem cell training to scientists at their Israel lab.
Dr. Battey noted that the Working Group agreed the use of the K18 Career Enhancement Award for stem cell research was a good training mechanism, but few investigators in mid-career have the luxury of taking two years off to pursue new research avenues. The Task Force commented that mid-career scientists may not need the full two years to receive this training.
Establish Embryonic Germ Cells Research
The Working Group had mixed opinions on the importance of studying embryonic germ (EG) cells because germ cells may not offer the same potential as ES cells. EG cells are also more difficult to grow than ES cells, which may be a reason why the EG field has not grown rapidly.
Revise the NIH Stem Cell Registry Web site
The Working Group agreed that the NIH Stem Cell Registry Web site lacks information on which providers actually have hES cells available for shipping. NIH is in the process of revising the Web site to provide scientists with accurate information on cell availability.
The meeting adjourned at 11:00 a.m.
If you have questions about the Task Force, please contact:
Science Policy and Planning Branch
National Institute on Deafness
and Other Communication Disorders, NIH
Bethesda, MD 20892
Phone: (301) 402-2313
Fax: (301) 402-2265