“That’s the beauty of this class, not only is the topic of stem cell engineering unique, but thanks to video conferencing technology, Georgia Tech students can now take a class with their peers from across the country,” said McDevitt, an associate professor in the Wallace H. Coulter Department of Biomedical Engineering.

Stem Cell Engineering (BMED 8813) has been offered since the spring of 2011 and was created by McDevitt as a way to educate graduate students about a research area that is becoming increasingly popular.

Including the 10 students at Tech, there are 39 students enrolled in this semester’s course. Aside from Tech, they are located at Washington University, the Massachusetts Institute of Technology, Boston University, University of California, Merced, and the University of Wisconsin. And although this is a graduate-level course, undergraduates can take the course with McDevitt’s permission.

So what can students expect during a week of classes? On Tuesdays, students from all of the participating campuses hear a lecture via the video conferencing system on a stem cell engineering topic — think everything from stem cell biology basics to stem cell biomanufacturing.

When the class meets on Thursdays, two students (at each location) typically lead a 50-minute discussion on a recently published journal article related to the lecture topic to their in-person peers.

Then, for the remainder of class, the Tech group video conferences with the students at other locations to discuss the key points brought up by each local group.

“It’s very helpful to have the perspective of students and faculty from other universities,”  said Jenna Wilson, a Ph.D. student in the bioengineering program who is a former student of the course turned teaching assistant. “Because people at other universities have different areas of research expertise, they can provide greater insight into aspects of the stem cell engineering field and pose interesting questions for discussion.”

Wilson also appreciated the small class size and discussion format of the course.

“Both aspects allow for great conversations with other students and some of the leading faculty in the stem cell engineering field,” she added. “Even though the class is broadcast across six universities, it's still a small group where you can feel comfortable sharing ideas and opinions.”

The course is typically offered during spring semester. For more information, email McDevitt .

McDevitt is an associate professor in the Coulter Department, a Petit Faculty Fellow in the Petit Institute for Bioengineering and Bioscience, and director of the Stem Cell Engineering Center at Georgia Tech. The objective of McDevitt’s research program is to develop enabling technologies for the directed differentiation of stem cells for regenerative medicine, disease models, and diagnostic applications. Much of his research focuses on the application of technologies to engineer stem cell fate, on stem cell bioprocessing and on engineering regenerative therapies from stem cells. McDevitt has garnered more than $9 million in funding, including a Transformative R01 award from the NIH and an NSF IGERT on Stem Cell Biomanufacturing. He received the 2010 Society for Biomaterials Young Investigator Award, a New Investigator Award from the American Heart Association and was recognized as one of the “40 Under 40” by Georgia Trend magazine. McDevitt graduated cum laude from Duke University, with a B.S.E. and a double major in Biomedical and Electrical Engineering. He received his Ph.D. in 2001 in Bioengineering from the University of Washington, where he worked for Patrick S. Stayton, and where he conducted post-doctoral research in the pathology laboratory of Charles E. Murry. 

Roy joined the Coulter Department this summer as professor and is currently the director of the Center for Immunoengineering.  He is an elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and a Fellow of the Biomedical Engineering Society (BMES). He received his B.S. from the Indian Institute of Technology, M.S. from Boston University and his Ph.D. in Biomedical Engineering from Johns Hopkins University. Following his Ph.D., he joined a start-up biotechnology company, Zycos Inc., where he served as a senior scientist in drug delivery research.  He joined The University of Texas at Austin in 2002, where most recently he was professor of Biomedical Engineering. He also served as the director of the graduate program and as associate chair for education and outreach. His research interests are in the areas of immunoengineering with particular focus on material-directed cells signaling and immune cell generation and controlled drug and vaccine delivery technologies with applications in cancer and immunotherapies.  Roy has received the Young Investigator Awards from The Society for Biomaterials (SFB) and the Controlled Release Society (CRS). He has been extensively funded by NIH, NSF, the Coulter Foundation, the Whitaker Foundation and the Cancer Prevention And Research Institute of Texas, among others. He serves as a member of the editorial boards for the Journal of Controlled Release and the European Journal of Pharmaceutics and Biopharmaceutics.

Georgia Tech and Emory created the joint department of biomedical engineering in the fall of 1997. The collaborative relationship blends the expertise of medical researchers at the Emory University School of Medicine with that of the engineering faculty at Georgia Tech, and is the first of its kind between a public and private institution. The collaboration has resulted in a biomedical engineering program that consistently ranks among the top five in the nation by U.S. News & World Report.

The reprogramming technique allows a small percentage of cells – often taken from the skin or blood – to become human induced pluripotent stem cells (hiPSCs) capable of producing a wide range of other cell types. Using cells taken from a patient’s own body, the reprogramming technique might one day enable regenerative therapies that could, for example, provide new heart cells for treating cardiovascular disorders or new neurons for treating Alzheimer’s disease or Parkinson’s disease.

But the cell reprogramming technique is inefficient, generating mixtures in which the cells of interest make up just a small percentage of the total volume. Separating out the pluripotent stem cells is now time-consuming and requires a level of skill that could limit use of the technique – and hold back the potential therapies.

To address the problem, researchers at the Georgia Institute of Technology have demonstrated a tunable process that separates cells according to the degree to which they adhere to a substrate inside a tiny microfluidic device. The adhesion properties of the hiPSCs differ significantly from those of the cells with which they are mixed, allowing the potentially-therapeutic cells to be separated to as much as 99 percent purity.

The high-throughput separation process, which takes less than 10 minutes to perform, does not rely on labeling technologies such as antibodies. Because it allows separation of intact cell colonies, it avoids damaging the cells, allowing a cell survival rate greater than 80 percent. The resulting cells retain normal transcriptional profiles, differentiation potential and karyotype.

“The principle of the separation is based on the physical phenomenon of adhesion strength, which is controlled by the underlying biology,” said Andrés García, the study’s principal investigator and a professor in Georgia Tech’s Woodruff School of Mechanical Engineering and the Petit Institute for Bioengineering and Bioscience. “This is a very powerful platform technology because it is easy to implement and easy to scale up.”

The separation process was described April 7 in the advance online publication of the journal Nature Methods. The research was supported by the National Institutes of Health (NIH) and the National Science Foundation (NSF), supplemented by funds from the American Recovery and Reinvestment Act (ARRA).

“The scientists applied their new understanding of the adhesive properties of human pluripotent stem cells to develop a quick, efficient method for isolating these medically important cells,” said Paula Flicker, of the National Institutes of Health’s National Institute of General Medical Sciences, which partly funded the research. “Their work represents an innovative conversion of basic biological findings into a strategy with therapeutic potential.”  

An improved separation technique is essential for converting the human induced pluripotent stem cells produced by reprogramming into viable therapies, said Todd McDevitt, an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, and director of Georgia Tech’s Stem Cell Engineering Center.

“For research purposes, depending on labeling reagents for separation is not a major problem,” said McDevitt, one of the paper’s co-authors. “But when we move into commercialization and manufacturing of cell therapies for humans, we need a technology approach that is unbiased and able to be scaled up.”

The separation technique, called micro stem cell high-efficiency adhesion-based recovery (µSHEAR), will allow standardization across laboratories, providing consistent results that don’t depend on the skill level of the users.  “Because of the engineering and technology involved, and the characterization work, we now have a technology that is readily transferrable,” McDevitt said.

The µSHEAR process grew out of an understanding of how cells involved in the reprogramming process change morphologically as the process proceeds. Using a spinning disk device, the researchers tested the adhesive properties of the hiPSCs, the parental somatic cells, partially-reprogrammed cells and reprogrammed cells that had begun differentiating. For each cell type, they measured its “adhesive signature” – the level of force required to detach the cells from a substrate that had been coated with specific proteins.   

The research team, which included Georgia Tech postdoctoral fellows Ankur Singh and Shalu Suri, tested their technique in microfluidic devices developed in collaboration with Hang Lu, a professor in Georgia Tech’s School of Chemical and Biomolecular Engineering.

In the testing, cells from the culture were first allowed to attach to the substrate before being subjected to the flow of buffer fluid. Cells with a lower adhesive signature detached from the substrate at lower flow rates. By varying the flow rate, the researchers were able to separate specific types of cells, allowing production of stem cell cultures with purity as high as 99 percent – from mixtures in which those cells accounted for only a few percent of the total.

“At different stages of reprogramming, we see differences in the molecular composition and distribution of the cellular structures that control adhesion force,” García explained. “Once we know the range of adhesive forces for each cell type, we can apply those narrow ranges to select the populations that come off in each range.”

Using inexpensive disposable “cassettes,” the microfluidic system could be scaled up to increase the volume of cells produced and to provide specific separations, García noted.

Unlike existing labeling techniques, the new separation process works on cell colonies, avoiding the need to risk damaging cells by breaking up colonies for separation. The separation process has been tested with both reprogrammed blood and skin cells. Cells were provided for testing by ArunA Biomedical, a company based in Athens, Ga., founded by University of Georgia professor Steven Stice.

Beyond the direct application in producing stem cells, the separation technique could also help scientists with other research in which cells need to be separated – including potential improvements in the reprogramming technique, which won the Nobel Prize for medicine in 2012.

“Cell reprogramming has been a black box,” said McDevitt. “You start the reprogramming process, and when the cells are fully reprogrammed, you can pick them out visually. But there are really interesting scientific questions about this process, and by isolating cells undergoing reprogramming, we may be able to make new discoveries about how the process occurs.”

In addition to those already mentioned, the project also included graduate student Ted Lee and research technician Marissa Cooke of Georgia Tech, researcher Jamie Chilton of ArunA, and Weiqiang Chen and Jianping Fu of the University of Michigan.

This work was supported by an ARRA supplement to the National Institutes of Health (NIH) awards R01 GM065918 and R43 NS080407, the Stem Cell Engineering Center at Georgia Tech, a Sloan Foundation Fellowship, by the National Science Foundation under award DBI-0649833 and an ARRA sub-award under grant RC1CA144825, and by NSF award CMMI-1129611, the Georgia Tech-Emory Center for Regenerative Medicine (GTEC) and the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Tech. Any conclusions are those of the authors and do not necessarily represent the official positions of the NIH or NSF.

CITATION: Singh, Ankur, et al., “Adhesion strength–based, label-free isolation of human pluripotent stem cells,” (Nature Methods, 2013). http://dx.doi.org/10.1038/nmeth.2437

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“We looked for projects along the innovation spectrum, including early-stage projects for which the potential payoffs justified taking the risk and projects supported by preliminary data that were at an advanced preclinical or early clinical stage,” said Regenerative Engineering and Medicine Center Co-Director Robert Guldberg, a mechanical engineering professor at Georgia Tech. Guldberg is also executive director of the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Tech.

Twenty-eight seed grant proposals from across the Georgia Tech and Emory campuses were submitted and those with the strongest potential for impacting the field of regenerative medicine were selected for funding.

“We are very excited that the funded proposals will initiate new partnerships among regenerative medicine researchers at institutions across Atlanta,” said Regenerative Engineering and Medicine Center Co-Director W. Robert Taylor, the Marcus Chair in Vascular Medicine and Director of the Division of Cardiology at the Emory University School of Medicine. Taylor is also a professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

The collaborative regenerative medicine initiative at Georgia Tech and Emory University began in 1998 with the establishment of the Georgia Tech/Emory Center for the Engineering of Living Tissues (GTEC), a National Science Foundation Engineering Research Center. Since then, more than 15 technologies have been licensed, 13 startup companies have been formed and three clinical trials are under way.

Today, more than 40 researchers from Georgia Tech and Emory University are working together as members of the Regenerative Engineering and Medicine Center, which launched in 2011, to develop integrated technologies and therapies that harness the body’s own cells and repair mechanisms to heal itself.

An interdisciplinary team of stem cell biologists, stem cell engineers and a surgeon from Georgia Tech, Emory University and Morehouse College received one of the $50,000 seed grants. The team plans to improve the quality of stem cells derived from the bone marrow of individuals with critical limb ischemia so that they can be used as a cellular therapy to prevent amputation in this patient population. Critical limb ischemia—a severe blockage in the arteries of the lower extremities that reduces blood flow—affects more than 500,000 people annually and can cause pain, tissue loss and lead to amputation.

“Mesenchymal stem cells derived from the bone marrow of healthy individuals have been shown to support new blood vessel growth and help re-establish blood flow to an affected area, but the quality of mesenchymal stem cells in individuals with critical limb ischemia is known to be poor because of the typical patient’s age and medical condition,” said Luke Brewster, an assistant professor in the Department of Surgery at Emory University.

To overcome this challenge, the research team plans to develop techniques for rejuvenating mesenchymal stem cells cultured from amputated ischemic patient limbs in a novel manner that will enhance cell expansion and reduce the inflammatory response.

In addition to Brewster, the research team also includes Todd McDevitt, an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University; Ian Copland, an assistant professor in the Department of Hematology and Medical Oncology at Emory University; and Alex Peister, an assistant professor in the Department of Biology at Morehouse College.

Julie Champion, an assistant professor in the School of Chemical and Biomolecular Engineering at Georgia Tech, received a $50,000 seed grant to create an innovative biomaterial capable of suppressing immune activity in the body. The material, which is made from engineered regulatory T-cell proteins, will operate through direct contact with immune cells.

The success of many regenerative medicine therapies is limited because the introduction of foreign biomaterials, cells or tissues into the body causes an inflammatory response. According to Champion, the new material she is developing could be incorporated into regenerative biomaterials directly, combined with cell or tissue therapies, or used as pre-treatments prior to regenerative therapy to suppress immune activity.

“This project demonstrates a new biomaterials platform that will interact directly with the immune system in both a physical and biological manner and could lead to innovative immune therapies for injured or sick patients that require regenerative medicine to heal and restore function,” said Champion.

A committee of investigators from Georgia Tech, Emory University, Children’s Healthcare of Atlanta and the University of Georgia awarded the grants that spanned basic science and translational research to researchers from a broad range of disciplines including engineering, medicine and biology.

Scores were based on the following primary criteria:

• the ability of the project to address an important clinical problem;
• the originality and innovation of the research; and
• the quality and expertise of the research and investigator(s).

“The seed grants also allow the unique blend of engineers, scientists and clinicians at Georgia Tech and Emory University who have a successful history of collaboration in regenerative engineering and medicine to help train the next generation of leaders in this rapidly growing, interdisciplinary field,” said Guldberg.

By: Abby Robinson, writer

“This grant provides a unique training opportunity for top engineering graduate students looking to understand how to control stem cells into clinically relevant numbers,” stated Todd McDevitt, PhD.

McDevitt, associate professor in the Wallace H. Coulter Department of Biomedical Engineering is co-directing the IGERT program with Robert M. Nerem, professor emeritus of the George W. Woodruff School of Mechanical Engineering at Georgia Tech.  McDevitt is also director of the Stem Cell Engineering Center which administers this award.

Recently highlighted by Nature magazine as one of the “out of the box” manufacturing educational programs in the country, the $3 million NSF-funded IGERT was awarded to Georgia Tech in 2010 to educate and train the first generation of Ph.D. students in the translation and commercialization of stem cell technologies for diagnostic and therapeutic applications.

The Stem Cell Biomanufacturing IGERT program supports new incoming Georgia Tech Ph.D. students for their first two years of graduate school. The program offers a core curriculum in stem cell engineering and bioprocessing coupled with elective tracks in advanced technologies, public policy, ethics or entrepreneurship.

“The current state of the field of stem cell research offers a unique opportunity for engineers to contribute significantly to the generation of robust, reproducible and scalable methods for phenotypic characterization, propagation, differentiation and bioprocessing of stem cells,” McDevitt added.

Trainees are afforded opportunities to meet with leading experts in the field who visit as part of the Stem Cell Engineering seminar series, attend the annual stem cell engineering workshop, participate in outreach activities and interact with representatives from leading companies during Georgia Tech’s annual Bio Industry Symposium.

Georgia Tech's Stem Cell Biomanufacturing IGERT award will support at least 30 graduate students over the 5 years of the award.

2012 Trainees

Olivia Burnsed - Wallace H. Coulter Department of Biomedical Engineering

Efrain Cermeno - Wallace H. Coulter Department of Biomedical Engineering

Albert Cheng - Wallace H. Coulter Department of Biomedical Engineering

Jose Garcia - George W. Woodruff School of Mechanical Engineering

Emily Jackson - School of Chemical and Biomolecular Engineering

2011 Trainees

Tom Bongiorno – George W. Woodruff School of Mechanical Engineering

Rob Dromms – School of Chemical and Biomolecular Engineering

Devon Headen – Wallace H. Coulter Department of Biomedical Engineering

Greg Holst – George W. Woodruff School of Mechanical Engineering

Torri Rinker – Wallace H. Coulter Department of Biomedical Engineering

Shalini Saxena – School of Material Science & Engineering

Josh Zimmerman – Wallace H. Coulter Department of Biomedical Engineering

2010 Trainees

Amy Cheng – George W. Woodruff School of Mechanical Engineering

Alison Douglas – Wallace H. Coulter Department of Biomedical Engineering

Jennifer Lei – George W. Woodruff School of Mechanical Engineering

Douglas White – Wallace H. Coulter Department of Biomedical Engineering

Jenna Wilson – Wallace H. Coulter Department of Biomedical Engineering

Researchers from the Georgia Institute of Technology and Emory University found that chromatin compaction is required for proper embryonic stem cell differentiation to occur. Chromatin, which is composed of histone proteins and DNA, packages DNA into a smaller volume so that it fits inside a cell. 

A study published on May 10, 2012 in the journal PLoS Genetics found that embryonic stem cells lacking several histone H1 subtypes and exhibiting reduced chromatin compaction suffered from impaired differentiation under multiple scenarios and demonstrated inefficiency in silencing genes that must be suppressed to induce differentiation.

“While researchers have observed that embryonic stem cells exhibit a relaxed, open chromatin structure and differentiated cells exhibit a compact chromatin structure, our study is the first to show that this compaction is not a mere consequence of the differentiation process but is instead a necessity for differentiation to proceed normally,” said Yuhong Fan, an assistant professor in the Georgia Tech School of Biology.

Fan and Todd McDevitt, an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, led the study with assistance from Georgia Tech graduate students Yunzhe Zhang and Kaixiang Cao, research technician Marissa Cooke, and postdoctoral fellow Shiraj Panjwani.

The work was supported by the National Institutes of Health’s National Institute of General Medical Sciences (NIGMS), the National Science Foundation, a Georgia Cancer Coalition Distinguished Scholar Award, and a Johnson & Johnson/Georgia Tech Healthcare Innovation Award.

To investigate the impact of linker histones and chromatin folding on stem cell differentiation, the researchers used embryonic stem cells that lacked three subtypes of linker histone H1 -- H1c, H1d and H1e -- which is the structural protein that facilitates the folding of chromatin into a higher-order structure. They found that the expression levels of these H1 subtypes increased during embryonic stem cell differentiation, and embryonic stem cells lacking these H1s resisted spontaneous differentiation for a prolonged time, showed impairment during embryoid body differentiation and were unsuccessful in forming a high-quality network of neural cells.

“This study has uncovered a new, regulatory function for histone H1, a protein known mostly for its role as a structural component of chromosomes,” said Anthony Carter, who oversees epigenetics grants at NIGMS.  “By showing that H1 plays a part in controlling genes that direct embryonic stem cell differentiation, the study expands our understanding of H1’s function and offers valuable new insights into the cellular processes that induce stem cells to change into specific cell types.”

During spontaneous differentiation, the majority of the H1 triple-knockout embryonic stem cells studied by the researchers retained a tightly packed colony structure typical of undifferentiated cells and expressed high levels of Oct4 for a prolonged time. Oct4 is a pluripotency gene that maintains an embryonic stem cell’s ability to self-renew and must be suppressed to induce differentiation.

“H1 depletion impaired the suppression of the Oct4 and Nanog pluripotency genes, suggesting a novel mechanistic link by which H1 and chromatin compaction may mediate pluripotent stem cell differentiation by contributing to the epigenetic silencing of pluripotency genes,” explained Fan. “While a significant reduction in H1 levels does not interfere with embryonic stem cell self-renewal, it appears to impair differentiation.”

The researchers also used a rotary suspension culture method developed by McDevitt to produce with high efficiency homogonous 3D clumps of embryonic stem cells called embryoid bodies. Embryoid bodies typically contain cell types from all three germ layers -- the ectoderm, mesoderm and endoderm -- that give rise to the various types of tissues and structures in the body. However, the majority of the H1 triple-knockout embryoid bodies formed in rotary suspension culture lacked differentiated structures and displayed gene expression signatures characteristic of undifferentiated stem cells.

“H1 triple-knockout embryoid bodies displayed a reduced level of activation of many developmental genes and markers in rotary culture, suggesting that differentiation to all three germ layers was affected.” noted McDevitt.  

The embryoid bodies also lacked the epigentic changes at the pluripotency genes necessary for differentiation, according to Fan.

“When we added one of the deleted H1 subtypes to the embryoid bodies, Oct4 was suppressed normally and embryoid body differentiation continued,” explained Fan. “The epigenetic regulation of Oct4 expression by H1 was also evident in mouse embryos.”

In another experiment, the researchers provided an environment that would encourage embryonic stem cells to differentiate into neural cells. However, the H1 triple-knockout cells were defective in forming neuronal and glial cells and a neural network, which is essential for nervous system development. Only 10 percent of the H1 triple-knockout embryoid bodies formed neurites and they produced on average eight neurites each. In contrast, half of the normal embryoid bodies produced, on average, 18 neurites.

In future work, the researchers plan to investigate whether controlling H1 histone levels can be used to influence the reprogramming of adult cells to obtain induced pluripotent stem cells, which are capable of differentiating into tissues in a way similar to embryonic stem cells.

Research reported in this publication was supported by the National Institute of General Medical Sciences of the National Institutes of Health (NIH) under award number GM085261 and the National Science Foundation under award number CBET-0939511. The content is solely the responsibility of the principal investigators and does not necessarily represent the official views of the NIH or NSF.

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This conference focused on the advancement of stem cell research and tissue engineering with regards to biology, tissue regeneration and development of cell-based therapies. These approaches are contributing to the development of applied efforts in stem cell biology and engineering that can combine to aid in the development of stem cell therapeutics and bioprocesses.

Jenna presented on the microfluidic single-cell analysis of embryoid body heterogeneity. Her abstract detailed the need for single cell analysis techniques in order to assess heterogeneous cell types, particularly pluripotent stem cells. She has been developing a microfluidic approach to analyze the individual phenotypes of the cells from single EBs. Through her research, she has found that the use of a microfluidic device can provide a better evaluation on the efficacy and efficiency of directed differentiation methods by parsing out single cell dynamics from broad population-based information.

Doug presented on his development of a computational model which can predict phenotypic changes of embryonic stem cells (ESCs) in 3-D embryoid bodies. His research objective is to utilize rules based spatial and cellular modeling to provide insight into the underlying mechanisms governing cell fate transitions in 3-dimensional microenvironments experienced by pluripotent stem cells. Through his research, he has found that the state transition between pluripotency is largely modulated by local regulatory networks.

A survey of more than 200 human embryonic stem cell researchers in the United States found that nearly four in ten researchers have faced excessive delay in acquiring a human embryonic stem cell line and that more than one-quarter were unable to acquire a line they wanted to study.

"The survey results provide empirical data to support previously anecdotal concerns that delays in acquiring or an inability to acquire certain human embryonic stem cell lines may be hindering stem cell science in the United States," said Aaron Levine, an assistant professor in the School of Public Policy in the Ivan Allen College of Liberal Arts at the Georgia Institute of Technology.

Results of the survey were published in the December issue of the journal Nature Biotechnology. Funding for the study was provided by the Kauffman Foundation's Roadmap for an Entrepreneurial Economy Program.

Levine administered the web-based survey in November 2010 to more than 1,400 stem cell scientists working at U.S. academic and non-profit medical research institutions. Almost 400 respondents from 32 states completed the survey. Of those, 205 respondents reported using human embryonic stem cells in their research, and their responses were used in this study.

The surveyed scientists cited four main reasons for their problems accessing human embryonic stem cell lines: difficulty obtaining material transfer agreements, failure to acquire research approval from internal institutional oversight committees, cell line owners that were unwilling to share and federal policy considerations.

"Bureaucratic challenges may be inevitable in this ethically contentious and politically sensitive field, but policymakers should attempt to mitigate these issues by doing things like encouraging institutions to accept third-party ownership verification and providing clearer guidance on human embryonic stem cell research not eligible for federal funding," said Levine, who is also a member of the Georgia Tech Institute for Bioengineering and Bioscience.

The broad patents assigned to the initial inventors of the method used to isolate embryonic stem cells and numerous narrower patents claiming specific human embryonic stem cell-related techniques are also factors complicating access to human embryonic stem cell lines, according to Levine.

When survey respondents were asked how many of the more than 1,000 existing human embryonic stem cell lines they used, 76 percent reported using three or fewer lines and 54 percent reported using two or fewer lines in their research. More than half of the 130 respondents cited access issues as a major reason they chose to use specific cell lines in their research.

"These results illustrate that many human embryonic stem cell scientists in the United States are not conducting comparative studies with a diverse set of human embryonic stem cell lines, which raises concern that at least some results are cell-line specific rather than broadly applicable," said Levine. "Federal and state funding agencies may want to consider encouraging research using multiple diverse human embryonic stem cell lines to improve the reliability of research results."

Embryonic stem cell lines are being used to develop new cellular therapies for various diseases, to screen for new drugs and to better understand inherited diseases. It's crucial that diverse lines are available for this research to ensure that all individuals benefit from the results.

While availability was cited as the most common factor affecting scientists' choices regarding which cell lines to use, other considerations included suitability for a specific project, familiarity with specific lines, a desire to reduce complications in the laboratory, cost, the extent of relevant literature and the preferences of scientists' colleagues.

Three of the initial human embryonic stem cell lines derived at the University of Wisconsin in the late 1990s were the lines most commonly used by respondents. Cell lines H1, H9 and H7 were used by 79, 68 and 26 percent of respondents, respectively. Scientists also reported using more than 100 other lines, but each of these was used by fewer than 12 percent of respondents.

"Other research communities in the life sciences have experienced material access problems and they addressed them, in part, by creating centralized information and data sharing hubs, including public DNA sequence databases, tissue banks and mouse repositories. The stem cell research community has taken promising steps in this direction, but this analysis should encourage the community to continue and, if possible, accelerate these efforts," added Levine.

Article Written by Abby Robinson, Georgia Tech Research News & Publications Office

Related Links

• Nature Biotechnology paper
• Aaron Levine
• School of Public Policy
• Institute for Bioengineering and Bioscience

The $3 million NSF-funded IGERT was awarded to Georgia Tech in 2010 to educate and train the first generation of PhD students in the translation and commercialization of stem cell technologies for diagnostic and therapeutic applications. The current state of the field of stem cell research offers a unique opportunity for engineers to contribute significantly to the generation of robust, reproducible and scalable methods for phenotypic characterization, propagation, differentiation and bioprocessing of stem cells.

Directed by Co-Principal investigators, Todd C. McDevitt, PhD, associate professor in the Wallace H. Coulter Department of Biomedical Engineering, and Robert M. Nerem, PhD, professor emeritus in the George W. Woodruff School of Mechanical Engineering, this grant provides a unique training opportunity to top engineering graduate students looking to understand how to scale and control stem cells into clinically relevant numbers. The goal, to train the next generation of experts in this new field of stem cell biomanufacturing for the development of stem cell technologies, diagnostics, and therapies.

Catalyzed by a surge of activity in the late 1990s, advances in stem cell biology over the past decade have continued to accelerate at a rapid pace. The manufacturing industry is expanding with commercial development of stem cell products projected to be $10 billion within the next 6-8 years. Moreover, the transformation from discoveries in stem cell biology to viable cellular technologies has enormous promise to revolutionize a range of applications for many aspects of society. As a result, stem cell biomanufacturing is on the verge of broadly impacting regenerative medicine, drug discovery and development, cell-based diagnostics and cancer.

Earlier this year, United States President Barack Obama asked Georgia Tech’s President G.P. “Bud” Peterson to join the Advanced Manufacturing Partnership steering committee to revolutionize manufacturing in the United States. Along with other industry and university representatives, the purpose of this committee is to identify and invest in the key emerging technologies, such as information technology, biotechnology and nanotechnology to help U.S. manufacturers improve cost, quality and speed of production in order to remain globally competitive. The stem cell biomanufacturing industry need look no further than President Peterson’s backyard for future experts in stem cell biomanufacturing.

“I have received dozens of calls and emails from industry looking for graduates of this program because of the uniqueness of the training and the need for manufacturing expertise,” stated McDevitt. “Georgia Tech has a real opportunity to become a leader in this emerging field and begin to answer questions about down-stream processes so that when the first clinical therapies are discovered, scientists are prepared to be able to respond with cells in the quantity and quality that will be needed for treatment.”

The Stem Cell Biomanufacturing IGERT is further catalyzed by the Stem Cell Engineering Center, which was also established in 2010 and brings together research laboratories from all over the state of Georgia to discuss and develop collaborative opportunities for research labs engineering novel stem cell based technologies, therapies, and diagnostics.

Georgia Tech's Stem Cell Biomanufacturing IGERT award will train over 30 graduate students in the first 5 years of the program. The IGERT offers a core curriculum in stem cell engineering and analytical design processes coupled with elective tracks in advanced technologies, public policy, ethics or entrepreneurship.

2011 Trainees 
Tom Bongiorno – George W. Woodruff School of Mechanical Engineering, Advisor – Todd Sulchek
Rob Dromms – School of Chemical and Biomolecular Engineering, Advisor – Mark Styczynski
Devon Headen – Wallace H. Coulter Department of Biomedical Engineering, Advisor – Andres Garcia
Greg Holst – George W. Woodruff School of Mechanical Engineering, Advisor – Craig Forest
Torri Rinker – Wallace H. Coulter Department of Biomedical Engineering, Advisor – Johnna Temenoff
Shalini Saxena – School of Material Science & Engineering, Advisor – Andrew Lyon
Josh Zimmerman – Wallace H. Coulter Department of Biomedical Engineering, Advisor – Todd McDevitt

2010 Trainees
Amy Cheng – George W. Woodruff School of Mechanical Engineering, Advisor – Andrés García
Alison Douglas – Wallace H. Coulter Department of Biomedical Engineering, Advisor – Thomas Barker
Jennifer Lei – George W. Woodruff School of Mechanical Engineering, Advisor – Johnna Temenoff
Douglas White – Wallace H. Coulter Department of Biomedical Engineering, Advisors – Melissa Kemp & Todd McDevitt
Jenna Wilson – Wallace H. Coulter Department of Biomedical Engineering, Advisor – Todd McDevitt

The five-year project focuses on developing biomaterials capable of capturing certain molecules from embryonic stem cells and delivering them to wound sites to enhance tissue regeneration in adults. By applying these unique molecules, clinicians may be able to harness the regenerative power of stem cells while avoiding concerns of tumor formation and immune system compatibility associated with most stem cell transplantation approaches.

"Pre-clinical and clinical evidence strongly suggests that the biomolecules produced by stem cells significantly impact tissue regeneration independent of differentiation into functionally competent cells," said Todd McDevitt, director of the Stem Cell Engineering Center at Georgia Tech and an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. "We want to find out if the signaling molecules responsible for scarless wound healing and functional tissue restoration during early stages of embryological development can be used with adult wounds to produce successful tissue regeneration without scar formation."

In addition to McDevitt, Coulter Department associate professor Johnna Temenoff and Woodruff School of Mechanical Engineering professor Robert Guldberg are also investigators on the project.

Regenerative medicine seeks to restore normal structure and function to tissues compromised by degenerative diseases and traumatic injuries. The contrast between embryonic and adult wound healing suggests that molecules that facilitate tissue regeneration during embryonic development are distinctly different from those of adult tissues.

This grant includes plans for engineering biomaterials that can efficiently capture morphogens, which are molecules secreted by embryonic stem cells undergoing differentiation. The study will also evaluate the regenerative activity of molecule-filled biomaterials in animal models of dermal wound healing, hind limb ischemia and bone fractures. Examining the effects of the morphogens on a range of animal wound models will increase the likelihood of success and define any limitations of the technology, such as its use for specific tissues or injuries.

"Biomaterials have largely been used in an attempt to direct stem cell differentiation or serve as passive cell transplantation vehicles for regenerative medicine and tissue engineering purposes," said McDevitt, who is also a Petit Faculty Fellow in the Institute for Bioengineering and Bioscience at Georgia Tech. "The idea of specifically engineering biomaterial properties to capture and deliver complex assemblies of stem cell-derived morphogens without transplanting the cells themselves represents a novel strategy to translate the potency of stem cells into a viable regenerative medicine therapy."

The award was one of 17 granted this year through the NIH Director's Transformative Research Projects Program (T-R01), which was created to challenge the status quo with innovative ideas that have the potential to advance fields and speed the translation of research into improved health for the American public.

Another T-R01 grant was awarded to Coulter Department professor Shuming Nie, associate professor May Wang and University of Pennsylvania School of Medicine Thoracic Surgery Research Laboratory director Sunil Singhal. That $7 million, five-year grant will support continuing work by the Emory-Georgia Tech Nanotechnology Center for Personalized and Predictive Oncology team on developing fluorescent nanoparticle probes that hone in on cancer cells and on creating instruments that visualize them for cancer detection during surgery.

Since its inception in 2009, the NIH Director's Award Program has funded a total of 406 high-risk research projects, including 79 T-R01 awards.

"The NIH Director's Award programs reinvigorate the biomedical work force by providing unique opportunities to conduct research that is neither incremental nor conventional," said James M. Anderson, director of the Division of Program Coordination, Planning and Strategic Initiatives, who guides the NIH Common Fund's High-Risk Research program. "The awards are intended to catalyze giant leaps forward for any area of biomedical research, allowing investigators to go in entirely new directions."

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“We applaud this initiative, and Georgia Tech is honored to collaborate to identify ways to strengthen the manufacturing sector to help create jobs in Georgia and across the United States,” said Peterson, who also serves as a member of the Secretary of Commerce's National Advisory Council on Innovation and Entrepreneurship.

The steering committee will guide the efforts of industry leaders, federal agency heads and university presidents, and will partner universities with industry and government agencies to develop new research and education agendas related to advanced manufacturing. 

The president also announced a new National Robotics Initiative as part of the advanced manufacturing and technology focus. Henrik Christensen, KUKA Chair of Robotics for Georgia Tech, serves as an academic and research leader on the National Robotics Initiative.

According to Christensen, this is a critical time for the U.S. While the last 25 years saw tremendous progress due to the Internet, the next game-changing revolution will be robotics.

“Robotics technology addresses a number of our nation’s most critical needs, including reinvigorating the U.S. manufacturing base, protecting our citizens and soldiers, caring for our aging population, preserving our environment, and reducing our dependence on foreign oil,” Christensen said. “Through the National Robotics Initiative, the United States can regain our leadership position from Europe, Japan and South Korea, both in terms of basic research and in terms of the application of the technology to secure future growth. As home to one of the nation’s top robotics programs, Georgia Tech is an enthusiastic member of this strategic effort.”

The Advanced Manufacturing Partnership will commit to form a multiuniversity, collaborative framework for the sharing of educational materials and best practices relating to advanced manufacturing and its linkage to the innovation.

Susan Hockfield, president of the Massachusetts Institute of Technology and Andrew Liveries of Dow Chemical are chairing the Advanced Manufacturing Partnership steering committee.  In addition to Peterson, other committee members include University of California at Berkley Chancellor Robert Birgeneau, University of Michigan President Mary Sue Coleman, Stanford President John Hennessy and Carnegie Mellon President Jared Cohon.

“Many of our challenges can be solved through innovation and fostering an entrepreneurial environment, as well as collaboration between industry, education and government to create a healthy economic environment and an educated workforce,” Peterson said. “This collaborative effort will facilitate job creation and global competitiveness and is a component of Georgia Tech’s strategic plan.”

Last year, the appeal to repeal the injunction blocking the NIH from funding research using embryonic stem cells was passed. A second victory for scientists recently occurred when courts ruled that “the Department of Health and Human Services would not prevent future presidents or Congresses from acting anew to limit government funding for research.” However, there is still some public opposition to using human embryos for research. The NIH will fund $125 million to stem cell research this year alone, but scientists are wary knowing this funding comes without long-term security.

The article details programs available to young scientist considering careers in stem-cell research in the US and around the world. Ms. Wadman recommended stem cell PhD programs at Stanford, the Sackler Institute of Graduate Biomedical Sciences at New York University School of Medicine, the University of Minnesota, and the Hanover Biomedical Research School in Germany.

She also commented on “the emerging need for biomanufacturures with stem-cell experitise, as exemplified by a new PhD prgoramme in stem-cell biomanufacturing at the Georgia Institute of Technology, funded by the US National Science Foundation. The programme opened its doors last year and is admitting six students per year. “If stem cells are going to move out of the lab, there will be lots of need for engineers to produce a large number of identical cells,” says Aaron Levine, assistant professor of public policy at Georgia Tech and researcher involved in the IGERT.

The Stem Cell Biomanufacturing IGERT program is headed by co-directors, Todd McDevitt, PhD and Bob Nerem, PhD, and offers enormous promise for researchers to become experts in stem cell biomanufacturing for the development of cell-based therapies, including regenerative medicine, drug discovery and development, cell-based diagnostics, and cancer. With funding for the next 4 years, this IGERT program is transforming the potential of stem cells for PhD scientists and engineers. 

View Article Here.

Aligned with the mission of the Stem Cell Engineering Center, the purpose of this workshop is to cultivate teams of researchers from the basic sciences to address key hurdles and technological challenges currently impeding the development of stem cell therapeutics and diagnostics.  

Stem cells, or unspecialized cells, hold tremendous promise as a biological resource for regenerative medicine therapies, pharmaceutical discovery and development, and cell-based diagnostic assays. Transforming the potential of stem cells into viable biomedical technologies and commercial applications is dependent on developing efficient, robust, non-destructive and scalable strategies to control, assay and manufacture stem cells and stem cell-derived products.  

Many of the unique challenges posed by stem cell research could be addressed by applying innovative technological advances occurring in adjacent disciplines for similar purposes, but different applications. Presentations during the workshop will include talks on differentiation technologies, bioanalytical techniques, multi-scale phenotypic analysis and stem cell biomanufacturing.  

New research presented on June 16, 2011 at the annual meeting of the International Society for Stem Cell Research (ISSCR) shows that systematically controlling the local and global environments during stem cell development helps to effectively direct the process of differentiation. In the future, these findings could be used to develop manufacturing procedures for producing large quantities of stem cells for diagnostic and therapeutic applications. The research is sponsored by the National Science Foundation and the National Institutes of Health.

"Stem cells don't make any decisions in isolation; their decisions are spatially and temporally directed by biochemical and mechanical cues in their environment," said Todd McDevitt, director of the Stem Cell Engineering Center at Georgia Tech and an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. "We have designed systems that allow us to tightly control these properties during stem cell differentiation, but also give us the flexibility to introduce a new growth factor or shake the cells a little faster to see how changes like these affect the outcome."

These systems can also be used to compare the suitability of specific stem cell types for a particular use.

"We have developed several platforms that will allow us to conduct head-to-head studies with different kinds of stem cells to determine if one type of stem cell outperforms another type for a certain application," said McDevitt, who is also a Petit Faculty Fellow in the Institute for Bioengineering and Bioscience at Georgia Tech.

Many laboratory growth methods allow stem cells to aggregate in three-dimensional clumps called "embryoid bodies" during differentiation. McDevitt and biomedical engineering graduate student Andres Bratt-Leal incorporated biomaterial particles directly within these aggregates during their formation. They introduced microparticles made of gelatin, poly(lactic-co-glycolic acid) (PLGA) or agarose and tested their impact on the assembly, intercellular communication and morphogenesis of the stem cell aggregates under different conditions by varying the microsphere-to-cell ratio and the size of the microspheres.

The researchers found that the presence of the biomaterials alone modulated embryoid body differentiation, but did not adversely affect cell viability. Compared to typical delivery methods, providing differentiation factors -- retinoic acid, bone morphogenetic protein 4 (BMP4) and vascular endothelial growth factor (VEGF) -- via microparticles induced changes in the gene and protein expression patterns of the aggregates.

By including tiny magnetic particles into the embryoid bodies during formation, the researchers also found they could use a magnet to spatially control the location of an aggregate and its assembly with other aggregates. The magnetic particles remained entrapped within the aggregates for the duration of the experiments but did not adversely affect cell viability or differentiation.

"With biomaterial and magnetic microparticles, we are beginning to be able to recreate the types of complex geometric patterns seen during early development, which require multiple cues at the same time and the ability to spatially and temporally control their local presentation," noted McDevitt.

While microparticles can be used to control differentiation by regulating the local environment, other methods exist to control differentiation through the global environment. Experiments by McDevitt and biomedical engineering graduate student Melissa Kinney have demonstrated that modulating hydrodynamic conditions can dictate the morphology of cell aggregate formation and control the expression of differentiated phenotypic cell markers.

"Because bioreactors typically impose hydrodynamic forces on cells to cultivate large volumes of cells at high density, our use of hydrodynamics to control cell fate decisions represents a novel, yet simple, principle that could be used in the future for the scalable efficient production of stem cells," added McDevitt.

Technologies capable of being directly integrated into bioprocessing systems will be the best choice for manufacturing large batches of stem cells, he noted. In the future, the development of multi-scale techniques that combine different levels of control -- both local and global -- to regulate stem cell differentiation may help the translation of stem cells into viable clinical therapies.

This project is supported by the National Science Foundation (NSF) (Award No. CBET 0651739) and the National Institutes of Health (NIH) (R01GM088291). The content is solely the responsibility of the principal investigator and does not necessarily represent the official views of the NSF or NIH.

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The discussion detailed how stem cell therapies are advancingfrom research labs to clinical applications at a cautious but accelerated pace.The reason: stem cells serve as the body’s most promising treatment option asthey have the potential to develop into many different types of cells including: blood cells, nervecells and muscle cells. However, there are many facets to stem cells therapiesthat are still unclear.

Dr. McDevitt explained the importance of researching allaspects of stem cells to better understand the effects of the stem celltherapies being developed and more importantly which stem cells are best forthe job. Currently, the Department of Defense is using stem cell therapies totreat wounded soldiers and more research isbeing done to repair spinal cords and damage caused by traumatic braininjuries. He stressed that the unknowns of stem cell therapies are still being discoveredand further study is necessary to find the best stem cell treatment for eachspecific problem.

The study shows that delivering stem cells on a polymer scaffold to treat large areas of missing bone leads to improved bone formation and better mechanical properties compared to treatment with the scaffold alone. This type of therapeutic treatment could be a potential alternative to bone grafting operations.

"Massive bone injuries are among the most challenging problems that orthopedic surgeons face, and they are commonly seen as a result of accidents as well as in soldiers returning from war," said the study's lead author Robert Guldberg, a professor in Georgia Tech's Woodruff School of Mechanical Engineering. "This study shows that there is promise in treating these injuries by delivering stem cells to the injury site. These are injuries that would not heal without significant medical intervention."

Details of the research were published in the early edition of the journal Proceedings of the National Academy of Sciences on January 11, 2010. This work was funded by the National Institutes of Health and the National Science Foundation.

The study was conducted in rats in which two bone gaps eight millimeters in length were created to simulate massive injuries. One gap was treated with a polymer scaffold seeded with stem cells and the other with scaffold only. The results showed that injuries treated with the stem cell scaffolds showed significantly more bone growth than injuries treated with scaffolds only.

Guldberg and mechanical engineering graduate student Kenneth Dupont experimented with scaffolds containing two different types of human stem cells -- bone marrow-derived mesenchymal adult stem cells and amniotic fluid fetal stem cells.

"We were able to directly evaluate the therapeutic potential of human stem cells to repair large bone defects by implanting them into rats with a reduced immune system," explained Guldberg, who is also the director of the Petit Institute for Bioengineering and Bioscience at Georgia Tech.

Micro-CT measurements showed no significant differences in bone regeneration between the two stem cell groups. However, combining the two types of stem cells produced significantly higher bone volume and strength compared to scaffolds without cellular augmentation.

Although stem cell delivery significantly enhanced bone growth and biomechanical properties, it was not able to consistently repair the injury. Eight weeks after the treatment, new bone bridged the gaps in four of nine defects treated with scaffolds seeded with adult stem cells, one of nine defects treated with scaffolds seeded with fetal stem cells, and none of the defects treated with the scaffold alone.

"We thought that the functional regeneration of the bone defects may have been limited by stem cells migrating away from the injury site, so we decided to investigate the fate and distribution of the delivered cells," said Guldberg.

To do this, Guldberg labeled stem cells with fluorescent quantum dots -- nanometer-scale particles that emit light when excited by near-infrared radiation -- to track the distribution of stem cells after delivery on the scaffolds and completed the same experiments as previously described.

Throughout the entire study, the researchers observed significant fluorescence at the stem cell scaffold sites. However, beginning seven to 10 days after treatment, signals appeared at the scaffold-only sites. Additional analysis with immunostaining revealed that the quantum dots present at the scaffold-only sites were contained in inflammatory cells called macrophages that had taken up quantum dots released from dead stem cells.

"While our overall study shows that stem cell therapy has a lot of promise for treating massive bone defects, this experiment shows that we still need to develop an improved way of delivering the stem cells so that they stay alive longer and thus remain at the injury site longer," explained Guldberg.

The researchers also found that the quantum dots diminished the function of the transplanted stem cells and thus their therapeutic effect. When the stem cells were labeled with quantum dots, the results showed a failure to enhance bone formation or bridge defects. However, the same low concentration of quantum dots did not affect cell viability or the ability of the stem cells to become bone cells in laboratory studies.

"Although in vitro laboratory studies remain important, this work provides further evidence that well-characterized in vivo models are necessary to test the ability of regenerative tissue strategies to effectively integrate and restore function in complex living organisms," added Guldberg. "Improved methods of non-invasive cell tracking that do not alter cell function in vivo are needed to optimize stem cell delivery strategies and compare the effectiveness of different stem cell sources for tissue regeneration."

Guldberg is currently exploring alternative cell tracking methods, such as genetically modifying the stem cells to express green fluorescent protein and/or other luminescent enzymes such as luciferase. He is also investigating the addition of programming cues to the scaffold that will direct the stem cells to differentiate into bone cells. These signals may be particularly effective for fetal stem cells, which are believed to be more primitive than adult stem cells, according to Guldberg.

Lessons learned from the current work are also being applied to develop effective stem cell therapies for severe composite injuries to multiple tissues including bone, nerve, vasculature and muscle. This follow-on work is being conducted in the Georgia Tech Center for Advanced Bioengineering for Soldier Survivability in collaboration with Ravi Bellamkonda and Barbara Boyan, professors in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

Other authors on the paper include Andres Garcia, professor and Woodruff Faculty Fellow in Georgia Tech's Woodruff School of Mechanical Engineering and the Petit Institute for Bioengineering and Bioscience; Georgia Tech research scientist Hazel Stevens, Georgia Tech graduate student Joel Boerckel; and National University of Ireland medical student Kapil Sharma.

This work was funded by grant number R01-AR051336 from the National Institutes of Health (NIH) and by grant number EEC-9731643 from the National Science Foundation (NSF). The content is solely the responsibility of the principal investigator and does not necessarily represent the official views of the NIH or NSF.

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“While the federal government still contributes more to stemcell research overall, each year since 2007 these six states have funded morehuman embryonic stem cell research than the federal government,” said AaronLevine, assistant professor at Georgia Tech.

Levine created an online searchable database (http://www.stemcellstates.net/) thatallows users to find detailed information about each grant given out by the sixstates that adopted programs specifically to fund stem cell research. Thedatabase currently covers grants given out by California, Connecticut,Illinois, Maryland, New Jersey and New York from December 2005 to December 2009,and will be updated yearly with new information.

“From what I could tell, only a relatively small portion ofthe stem cell research supported by these states was clearly ineligible forfederal funding,” said Levine, who is on the faculty of the School of PublicPolicy in the Ivan Allen College of Liberal Arts.

Levine reasons this could be a result of the fact that thereare many incentives for scientists to work with existing human embryonic stemcell lines rather than creating new ones.

He said he was surprised at how great the difference wasamong states in the share of grants that supported human embryonic stem cellresearch. While Connecticut and California devoted 97 percent and 75 percent oftheir grants to this research, New Jersey and New York steered only 21 percentto this contentious field.

One reason for these differences may be the development ofinduced pluripotent stem cells, which are derived from adult body cells ratherthan from embryos.  More recent programs,such as New York’s, may be disproportionally focusing on this new technology.

“There’s no question that thesestate programs drew a lot of scientists into the field,” said Levine.  “An interesting question going forward is howcommitted these scientists are to stem cell research or if they are relatingtheir work to stem cells now simply to be eligible for state funding – that’sunknown right now.”

While stem cell research is on the verge of broadly impacting many elements of the medical field -- regenerative medicine, drug discovery and development, cell-based diagnostics and cancer -- the bio-process engineering that will be required to manufacture sufficient quantities of functional stem cells for these diagnostic and therapeutic purposes has not been rigorously explored.

"Successfully integrating knowledge of stem cell biology with bioprocess engineering and process development into single individuals is the challenging goal of this program," said Todd McDevitt, an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University and a Petit Faculty Fellow in the Parker H. Petit Institute for Bioengineering and Biosciences at Georgia Tech.

McDevitt is leading the IGERT with Robert M. Nerem, professor emeritus of the George W. Woodruff School of Mechanical Engineering at Georgia Tech. Nerem is also director of the Georgia Tech/Emory Center (GTEC) for Regenerative Medicine, which will administer this award.

Ph.D. students funded by Georgia Tech's stem cell bio-manufacturing IGERT will receive interdisciplinary educational training in the biology, engineering, enabling technologies, commercialization and public policy related to stem cells. Their research efforts will focus on developing innovative engineering approaches to bridge the gap between basic discoveries made in stem cell biology and therapeutic stem cell-based technologies.

"This program provides a unique opportunity for engineers to generate standardized and quantitative methods for stem cell isolation, characterization, propagation and differentiation," said Nerem. "These techniques must be developed in a scalable manner to efficiently produce sufficient numbers of stem cells and derivatives in accessible formats in order to yield a spectrum of novel therapeutic and diagnostic applications of stem cells."

The Georgia Tech program is centered around three main research thrusts, which focus on several critical technologies that must be developed to enable the application and use of stem cell-based products:

• Creating reproducible, controlled and scalable methods to expand and differentiate stem cells with defined phenotypes and epigenetic states.

• Developing reliable, rapid and quantifiable methods to characterize the composition and function of stem cells to be generated.

• Designing low-cost systems capable of producing large populations of defined stem cells and derivatives.

Students in the program will be able to take advantage of the core facilities provided by the new Stem Cell Engineering Center at Georgia Tech, which is directed by McDevitt. Technologies developed by the students supported through this IGERT will be rapidly integrated into academic and industrial stem cell practices and cell-based products.

The award will support 30 new Ph.D. students over the next five years and brings together more than two dozen faculty members from Georgia Tech, Emory University, the University of Georgia and the Morehouse School of Medicine. In addition, plans are being made for students to participate in international research collaborations with the National University of Ireland at Galway, Imperial College London, the University of Cambridge and the University of Toronto.

"We anticipate this program will produce the future leaders and innovators in the field of stem cell bio-manufacturing who will contribute significantly at the interface of stem cell engineering, biology and therapy," added McDevitt.

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Alexandra Peister and her collaborators received an NIH program project grant which will support research at Morehouse, Georgia Institute of Technology, University of Rochester, Emory University, and the University of Queensland in Australia. The grant will be funded for the next two years and will support research at Morehouse at a level of $36,000 per year. Co-Investigator, NIH Challenge Grant (American Recovery and Reinvestment Act funded): Engineered Delivery of Adult Versus Fetal Stem Cells for Bone Regeneration in collaboration with Georgia Tech. The grant will be funded September 2009.

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