Stem cell guidelines on the way

You can now have your say about regulations on bringing stem cell therapies to the clinic. A special task force set up to create guidelines for bringing stem cell therapies from bench to bedside will be accepting public commentary on the guidelines, continuing until this fall, the group announced today at the annual meeting of the International Society for Stem Cell Research (ISSCR) here in Philadelphia. The task force's primary goals are to create guidelines that will help basic researchers

Andrea Gawrylewski
Jun 11, 2008
You can now have your say about regulations on bringing stem cell therapies to the clinic. A special task force set up to create guidelines for bringing stem cell therapies from bench to bedside will be accepting public commentary on the guidelines, continuing until this fall, the group announced today at the annual meeting of the International Society for Stem Cell Research (ISSCR) here in Philadelphia. The task force's primary goals are to create guidelines that will help basic researchers address the regulatory challenges of stem cell therapies. In particular, the task force of more than 30 members from 13 countries will address issues of standardizing stem cell populations -- making sure each line is uncontaminated by others, and that the cells are at a uniform state of differentiation. Similar issues were discussed in April at a linkurl:meeting;http://www.the-scientist.com/blog/display/54544/ of the Food and Drug Administration. But it seems that the ISSCR...
ng stem cell therapies from bench to bedside will be accepting public commentary on the guidelines, continuing until this fall, the group announced today at the annual meeting of the International Society for Stem Cell Research (ISSCR) here in Philadelphia. The task force's primary goals are to create guidelines that will help basic researchers address the regulatory challenges of stem cell therapies. In particular, the task force of more than 30 members from 13 countries will address issues of standardizing stem cell populations -- making sure each line is uncontaminated by others, and that the cells are at a uniform state of differentiation. Similar issues were discussed in April at a linkurl:meeting;http://www.the-scientist.com/blog/display/54544/ of the Food and Drug Administration. But it seems that the ISSCR is no closer to any concrete guidelines than the FDA. Several members of the audience today raised questions about how ISSCR intended to enforce its regulations, what specific terms in the preliminary draft of guidelines mean, and what impact the regulations will have on global regulatory groups. Task force leader linkurl:Olle Lindvall,;http://stemstroke.eu/partners/olle-lindvall from the University of Lund, in Sweden, replied that the group did not yet have the answers. Lindvall said the task force appreciates the FDA's work in parsing out regulating cell-based therapies, but that the ISSCR guidelines are intended to have broader impact and be an international document. You can post comments to the draft guidelines on the ISSCR Web site linkurl:here.;http://www.isscr.org/clinical_trans/index.cfm By the end of the year the task force plans to have a finalized version of the document. With several stem cell-based therapies chomping at the bit to enter clinical trials, let's hope the guidelines appear sooner rather than later.

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