January 6, 2004, Summary
NIH Stem Cell Task Force
James Battey, NIDCD (Chair); Arlene Chiu, NINDS; Robert Hammond, NIDDK; Ron McKay, NINDS; Mahendra Rao, NIA; Pam Robey, NIDCR; John Thomas, NHLBI; Judith Vaitukaitis, NCRR
Tony Beck, NCRR; Laura Cole, NIDCD; Donald Fink, CBER/FDA; Guy Fogleman, NCRR; Tom Johnson, OD/OSP; Ted Roumel, OD/OTT; Mobin Tawakkul, NIDCD; Anne White-Olson, NIDCD; Baldwin Wong, NIDCD
Dr. Battey welcomed the members to the eighth meeting of the NIH Stem Cell Task Force and thanked them for their continued commitment. He announced that he is representing the U.S. at the International Stem Cell Forum in Stockholm, Sweden on January 16th.
II. Approval of October 10, 2003 Meeting minutes
The Task Force unanimously approved the summary of the October 10, 2003 meeting, which will be posted on the NIH Stem Cell website at http://stemcells.nih.gov/policy/taskForce/tfSummaries/2003_10_10tfs.asp
III. Update on Stem Cell Characterization Unit
Dr. McKay provided the Task Force with an update of the Unit's activities. Four employees are now working for the Unit, and have been growing 4-5 human embryonic stem cell (hESC) lines for 2 months. The status and availability of some eligible lines on the NIH Stem Cell Registry is still unclear. The Unit is participating in a multinational collaborative effort to share reagents in order to standardize some hESC growing conditions. They are working with Tom Reid's lab at NCI to do karyotype analysis of Federally approved hESC lines. Dr. McKay has established a collaboration with Dr. Peter Andrews in the UK to compare the US Federally approved lines with those lines in the UK not eligible for US Federal funds. The Unit will now work to analyze the undifferentiated cell state and grow lines from single cells (subcloning).
The Task Force discussed the karyotype stability of hESCs in light of recent reports of trisomies in chromosomes 12 and 17 and alterations similar to those observed in teratocarcinomas. Overall, the cells seem to be relatively stable and some lines have been passaged over 100 times without introducing notable alterations. However, hESCs may become an important resource for cancer researchers in the near future. Enzymes used to pass the cells may introduce changes—mechanical passaging may be preferable. Any changes in reagents may also change the cells' behavior and potential. The Unit may wish to collaborate with outside experts to study the influence of reagents and passaging techniques upon karyotype stability and cell potential.
IV. NIH Stem Cell Briefing—January 7, 2004
Dr. Battey reported that NIH is hosting a stem cell briefing to provide the NIH Director with stem cell researchers' personal perspectives regarding the state of the science in stem cell research. Speakers will include Drs. Austin Smith (U. Edinburgh, UK), Irving Weissman (Stanford), Douglas Melton (Harvard), Leonard Zon (Boston Children's Hospital), Mahendra Rao (NIH- NIA), and Ronald McKay (NIH-NINDS.) Members of the Task Force are welcome to attend the meeting, to be held Wednesday January 7, 2004, from 1:00–4:30 PM in Wilson Hall of Building One.
V. NIH Human Embryonic Stem Cell Registry Update Schedule
Dr. Battey reported that a memo specifying how and when the NIH Stem Cell website will be updated will be sent to HHS. The memo proposes that the NIH Human Embryonic Stem Cell Registry ("the Registry") be updated quarterly. Science advances will be updated weekly, and the NIH report titled "Stem Cells: Scientific Progress and Future Directions" will be updated every 2–3 years.
Dr. Battey requested Task Force advice regarding how to update existing entries on the Registry. The group agreed that entries should be annotated to accurately reflect their viability and usefulness for researchers. The phrase "failed to expand as an undifferentiated cell line capable of multipotent differentiation" was recommended where appropriate. The group also agreed that documentation from the provider is required before an entry on the registry may be annotated. Providers who do not respond to enquiries about their entries on the registry will be labeled as "TBD" or "not verified."
The Task Force discussed a need for clarification regarding Federally funded investigators' use of reagents or tools developed using non-eligible hESC lines and whether reagents or tools developed with Federal funds may be provided to those studying non-eligible hESC lines. The group decided that the Office of General Counsel (OGC), NIH, should be contacted to advise the Task Force on these issues. Drs. Rao and McKay will draft a memo requesting that a representative from OGC attend an upcoming Task Force meeting to provide this advice.
VI. Continued Review and Discussion of Stem Cell Task Force Working Groups Suggestions
Task Force members discussed some of the remaining suggestions from the Supporting Technologies/Research Tools Working Group. Highlights of the Task Force's discussion:
- Create New Tools and Technologies. Supplements to infrastructure grants may be used to meet the goal of developing feeder-free media and other expansion technologies for hESCs. SBIRs can support development of reagents and technologies. With adequate justification, phase I and 2 SBIR applications may be consolidated ("Fast Track") to provide levels of funding considerably greater (e.g., $1 million dollars) than the traditional SBIR applications.
- Develop New Mechanisms to Fuel Collaboration and Partnerships. Existing IC mechanisms may be useful for this purpose. Examples include infrastructure supplements and extensions on SBIRs and STTRs. An RFA may be needed because such applications fare poorly in study sections. NIH Intramural researchers should be encouraged to collaborate with extramural researchers. The high price for hESCs charged to biotech companies may be illegal if it exceeds actual costs. NIH should try to lower hESC prices for both academic and biotech industry researchers. NIH's Office of Technology Transfer will examine the MTAs NIH made with hESC providers to determine if we have any leverage for adjusting the cost.
- Provide Flexibility by Expediting the NIH Time Frame for Review of Applications. Many of the suggestions made under this category would benefit all research activities, not merely stem cell research. Investigators may already determine if an IC is interested in funding a project area by having informal discussions with the IC program director.
- Develop Disease Models. The group agreed that modification of human ES cells to develop animal models of human diseases by direct implantation into adult animals was a laudable goal and should be presented to the Implementation Committee for consideration.
Due to time constraints, the Task Force elected to continue discussion of suggestions from the Supporting Technologies/Research Tools and Outreach Working Groups at the next meeting.
VII. Identification of Issues for Task Force Consideration—Around the Table
Dr. Thomas reported that NHLBI is going forward with an RFA to fund up to 3 Centers for Cell-Based Therapies in FY 05. Dr. Battey offered to announce this initiative on the NIH Stem Cell website.
The next meeting of the Stem Cell Task Force is tentatively scheduled for Wednesday, April 7, 2004, 9:00–11:00 AM, 31/3C05.
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