October 27, 2004, Summary
NIH Stem Cell Task Force
James Battey, NIDCD (Chair); Daniela Gerhard, NCI; Robert Hammond, NIDDK Ron McKay, NINDS; Pam Robey, NIDCR; Allen Spiegel, NIDDK; Richard Tasca, NICHD; Marion Zatz, NIGMS
Tony Beck, NCRR; Laura Cole, NIDCD; Sherry Dupere, CSR; Don Fink, FDA; Tom Johnson, OD/OSP; Lisa Montney, NIDCD; Jack Spiegel, OD/OTT; Anne White-Olson, NIDCD; Baldwin Wong, NIDCD
Dr. Battey welcomed the Task Force Members to the eleventh meeting of the NIH Stem Cell Task Force and thanked them for their continued commitment. Prior to beginning the meeting, Dr. Battey announced an issue that was raised at a recent meeting of the National Academy of Sciences that discussed stem cell research guidelines. At the meeting, Dr. Fred Gage, UCSD, reported on his findings that all of the 22 human embryonic stem cell (hESC) lines that are eligible for Federal funding have been contaminated by a cell-surface sialic acid that is present in all mammals except humans because these hESC lines have been cultured with animal products (mouse feeder layers, fetal calf serum). This would pose immune rejection problems if these cells were ever to be transplanted into humans. Although this is a safety concern, potential solutions can be developed to reduce the risk of immune rejection of transplanted cells. The Task Force discussed ways that scientists could eliminate this particular sialic acid in hESC lines. (This issue applies to all hESC lines grown with animal products and not only the lines eligible for federal funding).
Approval of Meeting minutes
The Task Force approved the text of the July 20, 2004, meeting minutes, which will be posted on the NIH Stem Cell Information website at http://stemcells.nih.gov/policy/taskForce/tfSummaries/pages/2004_07_20tfs.aspx.
II. Update of NIH hESC Grant Review
Dr. Sherry Dupere, Chief of the Biology of Development and Aging IRG at CSR, presented an "Update of hESC Grant Application Review at NIH." Dr. Dupere is the point person for hESC application review at CSR. She presented NIH hESC grant application data from IMPAC II for the advisory council rounds from May 2002 to October 2004. Prior to discussion of the data, she explained:
- CSR has limited the referral of hESC applications to seven existing, standing study sections. The purpose of this clustering is to facilitate the review of these applications including uniformity and comparability of review across study sections.
- if a principal investigator requests that his/her application be assigned to another study section, CSR will consider this request.
- there are special items for a Scientific Review Administrator to consider when addressing applications proposing the use of hESCs. This information is provided to the SRAs and reviewers.
- the SRA can designate the hESC line in IMPAC II.
- it is difficult to recruit reviewers for study sections for hESC review since so many of them are serving on existing study sections or on other IC review panels.
- whether hESC applications should be assigned to a special emphasis panel or stay in mainstreamed review. The Task Force previously suggested keeping the applications as mainstreamed and CSR also shares this opinion.
Discussion followed about the difficulties in getting reviewers to serve on hESC study sections. One suggestion from the Task Force was to consider including reviewers from industry or other countries. The Task Force asked Dr. Dupere to provide additional information with the data on administrative supplements separated from the R01 review data. Dr. Dupere will provide this data to the Task Force.
III. Stem Cell Sublines
Dr. Battey announced that some of the providers on the NIH Stem Cell Registry have developed sublines because of chromosome abnormalities in the original cells or for other reasons. These providers have requested that NIH post their sublines on the NIH Registry. The Task Force discussed that these sublines may have different characteristics than the parent lines and it is useful to present this information to the research community. Dr. Battey proposed a modification to the NIH Registry web site indicating whether or not a provider has sublines. If sublines are available, the purchaser could contact the provider directly for more information on these sublines or to order the sublines. The Task Force agreed that the NIH Registry be updated to show the availability of sublines and then link to the provider's web site.
IV. Re-issuance of T15 Program Announcement
Dr. Battey asked the Task Force if they would endorse re-issuing the Program Announcement for hESC short-term cell culturing courses funded by the T15 training grants. As it is known, hESCs are difficult to grow without the proper training. NIH has supported the training courses for scientists interested in working with hESCs since 2003. It was noted that the T15 courses is one way to train scientists in the art of culturing hESCs and hopefully will increase the base of scientists that can conduct research in this new field. The Task Force agreed to the need to reissue the PA. Mr. Wong will contact the NIH Stem Cell Implementation Committee to solicit support for this program.
V. 2005 NIH Stem Cell Symposium
Mr. Wong reminded the Task Force that NIH held a hESC symposium in 2003 to showcase NIH-supported research and asked the Task Force if NIH should host a similar event in 2005. The Task Force discussed whether there were significant advances in the field since 2003. In addition, since NIH is preparing to fund the Centers of Excellence in Translational Human Stem Cell Research and the Stem Cell Bank in FY05, the Task Force suggested that NIH should wait before hosting another hESC symposium so research highlights from these two initiatives could be included.
If NIH does not sponsor a hESC symposium in 2005, Dr. Beck suggested that the annual meeting of the R24/T15 grantees (infrastructure and training) be held in San Francisco before or after the ISSCR meeting in June 2005.
VI. Identification of Issues for Task Force Consideration
Dr. Battey asked if the Task Force had any other issues to discuss.
- Dr. Gerhard announced that the SAGE data from H9 is complete and can be accessed on SAGE Genie (http://cgap.nci.nih.gov/SAGE) as well as through the NIH Stem Cell Information website.
- Dr. Spiegel mentioned that NIDDK has received a proposal from Baylor University to create BAC (bacterial artificial chromosome) libraries of hESC lines. Such libraries would facilitate the development of gene knock outs in hESC lines, providing models for human diseases. The proposal was forwarded to NHGRI for consideration, and the Baylor investigators have been apprised of issues to address if they wish to receive funding.
- Dr. Zatz announced that the NIH will be issuing a Program Announcement (PA) for F32 and F33 hESC applications (Individual Postdoctoral Fellowship and Senior Fellowships) and NIDCD, NIDDK and NICHD will be co-funding this effort. In addition, she announced that NIGMS received numerous applications for new P20 hESC Exploratory Centers. NIGMS plans to expand the funding to the three current P20 Centers for an additional year before NIGMS introduces availability of the P50s (Multiple Project Center Grants).
Dr. Battey announced that the next meeting of the Task Force is tentatively scheduled for February 2, 2005, 9:00–11:00 a.m. in 31/3C05.
The meeting adjourned at 10:35 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