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Law, ethics, religion, and clinical translation in the 21st century--a discussion with Derek Hei. Interview by Majlinda Lako, Alan O. Trounson, Susan Rainey Daher.

Hei D - Stem Cells (2010)

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He then entered industry, where he worked for seven years at Genentech and then Cerus Corp., developing recombinant protein and cell-based biotherapeutics and rising to the position of Director of Biomedical Engineering at Cerus Corp... In September 2005, the National Stem Cell Bank (NSCB) was established in Madison, Wisconsin, as an NIH-funded resource to grow, characterize, and distribute cell lines listed on the NIH Human Pluripotent Stem Cell Registry (a list of embryonic stem cells lines eligible for use in federally funded research), and to provide comprehensive technical support to stem cell researchers around the world... The NSCB with Derek Hei and James Thomson as Directors has been hosted by the WiCell Research Institute, a non-profit, supporting organization of the University of Wisconsin at Madison established in 1999 to focus on enhancing and expanding the study of human pluripotent stem cells by supporting basic research, establishing research protocols, and creating and distributing cell lines... The Wisconsin International Stem Cell Bank (WISC) will likely continue to distribute hESC lines. ” The WISC bank (http://www.wicell.org) was originally established by WiCell in 1999 to cover distribution of hES cells as well as other pluripotent stem cell lines not included in the National Stem Cell Bank... Genetic stability is another big issue... We need to know what key factors impact genetic stability as well as the impact of low levels of abnormal cells on the safety profile for stem cell-based therapeutics... We need to ask questions, such as whether genetic stability differs from line to line, and determine the critical steps in culture and cryopreservation that contribute to the development of abnormal karyotypes... I think that we also need a better understanding of the impact of residual undifferentiated ES cells, along with methods for detecting and removing those cells, and animal models for determining the impact of specific levels of undifferentiated cells on product safety... Although some labs may like the idea of receiving funding for cell banking, it is not typically a job that labs are willing to make a long-term commitment toward. ” Dr. Hei notes that researchers in the United States are still working on the impact of the new NIH research guidelines that went into effect in July 2009. “Although we now have new approved hESC lines and NIH-funded hESC research projects, many of these researchers have been forced to work with new cell lines... Another major problem is that depositing cell lines is voluntary... From my perspective, it would be more efficient to work toward a centralized banking system and encourage investigators to deposit their hESC lines. ” Dr. Hei points out that although iPS cells are a promising new technology that helps to avoid many of the difficult ethical issues associated with hESCs, we are still early in the learning process. “Human ES cells will continue to be important for research and may continue to be the most suitable cell type for allogeneic cell therapy applications. iPS cells have a long way to go before there are clinical applications but may offer long-term hope to address chronic diseases where autologous therapeutics may be needed to address immune rejection issues... Education is obviously critical... These cell types are not necessarily interchangeable and each cell type may be beneficial for specific clinical applications... Unfortunately, it will likely take many years of research and human clinical studies to clearly understand the differences in therapeutic potential between hESC, iPS, and adult stem cell types. ”

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Derek Hei, PhD. University of Wisconsin Stem Cell and Regenerative Medicine Center.
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fig01: Derek Hei, PhD. University of Wisconsin Stem Cell and Regenerative Medicine Center.


Law, ethics, religion, and clinical translation in the 21st century--a discussion with Derek Hei. Interview by Majlinda Lako, Alan O. Trounson, Susan Rainey Daher.

Hei D - Stem Cells (2010)

Derek Hei, PhD. University of Wisconsin Stem Cell and Regenerative Medicine Center.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2962902&req=5

fig01: Derek Hei, PhD. University of Wisconsin Stem Cell and Regenerative Medicine Center.

View Article: PubMed Central - PubMed

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

He then entered industry, where he worked for seven years at Genentech and then Cerus Corp., developing recombinant protein and cell-based biotherapeutics and rising to the position of Director of Biomedical Engineering at Cerus Corp... In September 2005, the National Stem Cell Bank (NSCB) was established in Madison, Wisconsin, as an NIH-funded resource to grow, characterize, and distribute cell lines listed on the NIH Human Pluripotent Stem Cell Registry (a list of embryonic stem cells lines eligible for use in federally funded research), and to provide comprehensive technical support to stem cell researchers around the world... The NSCB with Derek Hei and James Thomson as Directors has been hosted by the WiCell Research Institute, a non-profit, supporting organization of the University of Wisconsin at Madison established in 1999 to focus on enhancing and expanding the study of human pluripotent stem cells by supporting basic research, establishing research protocols, and creating and distributing cell lines... The Wisconsin International Stem Cell Bank (WISC) will likely continue to distribute hESC lines. ” The WISC bank (http://www.wicell.org) was originally established by WiCell in 1999 to cover distribution of hES cells as well as other pluripotent stem cell lines not included in the National Stem Cell Bank... Genetic stability is another big issue... We need to know what key factors impact genetic stability as well as the impact of low levels of abnormal cells on the safety profile for stem cell-based therapeutics... We need to ask questions, such as whether genetic stability differs from line to line, and determine the critical steps in culture and cryopreservation that contribute to the development of abnormal karyotypes... I think that we also need a better understanding of the impact of residual undifferentiated ES cells, along with methods for detecting and removing those cells, and animal models for determining the impact of specific levels of undifferentiated cells on product safety... Although some labs may like the idea of receiving funding for cell banking, it is not typically a job that labs are willing to make a long-term commitment toward. ” Dr. Hei notes that researchers in the United States are still working on the impact of the new NIH research guidelines that went into effect in July 2009. “Although we now have new approved hESC lines and NIH-funded hESC research projects, many of these researchers have been forced to work with new cell lines... Another major problem is that depositing cell lines is voluntary... From my perspective, it would be more efficient to work toward a centralized banking system and encourage investigators to deposit their hESC lines. ” Dr. Hei points out that although iPS cells are a promising new technology that helps to avoid many of the difficult ethical issues associated with hESCs, we are still early in the learning process. “Human ES cells will continue to be important for research and may continue to be the most suitable cell type for allogeneic cell therapy applications. iPS cells have a long way to go before there are clinical applications but may offer long-term hope to address chronic diseases where autologous therapeutics may be needed to address immune rejection issues... Education is obviously critical... These cell types are not necessarily interchangeable and each cell type may be beneficial for specific clinical applications... Unfortunately, it will likely take many years of research and human clinical studies to clearly understand the differences in therapeutic potential between hESC, iPS, and adult stem cell types. ”

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