June 5, 2003, Summary
NIH Stem Cell Task Force
James Battey, NIDCD (Chair); Arlene Chiu, NINDS; Greg Downing, NCI; Robert Hammond, NIDDK; John Thomas, NHLBI
Tony Beck, NCRR; Amy Blackburn, NIH Management Intern; Laura Cole, NIDCD; Anthony Hayward, NCRR; Jean Henslee-Downey, NHLBI; Louise Ramm, NCRR; Belinda Seto, OER; Anne White-Olson, NIDCD; Baldwin Wong, NIDCD
Dr. Battey welcomed the members to the fifth meeting of the NIH Stem Cell Task Force and thanked them for both their time and their commitment.
II. Approval of March 11, 2003, Meeting Minutes
Prior to today's meeting, a copy of the March 11 meeting minutes were transmitted to all Task Force members for review and comments. The members approved the minutes, which will be posted on the NIH Stem Cell Web site at http://stemcells.nih.gov/policy/taskForce/tfSummaries/pages/03_11_03.aspx.
III. Senate Stem Cell Hearing
Dr. Battey provided a brief summary of the May 22nd stem cell hearing before Senator Arlen Specter, Chairman, Senate Labor/HHS/Education Appropriations Subcommittee. The NIH witnesses included Drs. Zerhouni, Battey and McKay. The purpose of the hearing was to discuss a recent published article by Johns Hopkins University scientists who weaned human embryonic stem cells (hESCs) from mouse feeder layers to human feeder layers. Senator Specter was especially interested in knowing if growing hESCs on human feeder layers rather than on mouse feeder layers was a safer technique and thus may result in using hESCs in clinical trials sooner. The hearing also discussed the status of eligible hESC lines developed by providers in Sweden. Some of the Swedish lines have not come in contact with mouse feeder layers. The Task Force discussed the difficulty in tracking the status of each of the eligible hESC lines since the lines are privately owned. The providers are not required to inform NIH about their derivations, but providers that have an Infrastructure grant do share that information with NIH.
IV. Stem Cell Infrastructure Grants
Drs. Hayward, Beck and Hammond discussed plans for the June 13 meeting with the grantees of NIH stem cell Infrastructure awards. Because some of the awards are nearing the completion of their two-year funding period, a topic for discussion at the June 13 meeting will be on NIH's proposed plans for the future of these awards. The Infrastructure grants are awarded to eligible stem cell providers listed on the NIH Human Embryonic Stem Cell Registry to assist them in costs for scale-up and distribution of hESCs to the research community. The NIH National Center for Research Resources (NCRR) is the lead IC in funding the Infrastructure grants with NIDDK funding two grants and additional co-funding from NIA and NICHD. The Task Force further discussed the future of the Infrastructure grants.
V. Supporting Technologies/Research Tools Working Group Meeting
Dr. Battey provided highlights from the May 14 meeting of the Stem Cell Supporting Technologies/Tools in Basic Research Working Group. The purpose of the working group was to discuss research tools and reagents needed to support basic research and development for human embryonic stem cell biology. The working group suggested the Task Force consider the following topics:
- Consider a mechanism to provide supplemental funds for researchers who wish to purchase stem cells.
- Work with stem cell suppliers to help them provide quality controls (e.g., purity, sterility, karyotype analysis, surface antigen analysis, verification of a lack of contamination) to accompany each lot of hESCs that is shipped.
- Inquire whether current SC suppliers evince any interest in a central stem cell repository.
- Lower legal barriers to commercialization and access (e.g., intellectual property issues, material transfer agreements (MTAs)). It was proposed that a standard MTA be created that features terms reasonable to both the academic investigators and small biotechnology companies.
- Create and standardize a "starter kit" to insure that recipients of stem cells will be able to grow the cells, provided that protocol is followed.
- Provide standardized, quality-controlled media (or perhaps a "universal medium") and reagents for cell growth and expansion. Mechanisms proposed to accomplish this and the previous suggestion included Small Business Innovation Research (SBIR) and contract mechanisms.
The Task Force will revisit the suggestions from the May 14th working group meeting at another meeting of the Task Force.
The meeting adjourned at 4:25 p.m. The next meeting of the Task Force is scheduled for July 17, 2003.
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