To address this problem, a startup company based on technology developed at the Georgia Institute of Technology is creating an efficient, safe and repeatable delivery method that protects cells from death and migration from the treatment site. Using microbead technology developed in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, SpherIngenics is producing protective capsules for the delivery of cell-based therapies.
Supported by a broad range of Georgia Tech initiatives, the company recently received a two-year $730,000 Phase II Small Business Innovation Research (SBIR) grant from the U.S. Department of Defense to continue development of the technology.
“When damaged tissue is being repaired by a cell-based therapy, our microbead technology ensures that cells travel to and remain in the targeted area while maintaining continued viability,” said SpherIngenics CEO Franklin Bost, who is also a professor in the Coulter Department. “This technology has the potential to reduce the cost of treatment by eliminating the need for multiple therapeutic procedures.”
Bost and Coulter Department Professors Barbara Boyan and Zvi Schwartz founded the company in 2007. They worked with the Georgia Tech Research Corporation to license five patents from Boyan’s lab for technology originally developed in the Georgia Tech/Emory Center for the Engineering of Living Tissue (GTEC), which was funded by a grant from the National Science Foundation. Then they secured $450,000, which included a Phase I SBIR grant from the U.S. Department of Defense and grants from the Georgia Research Alliance and the Coulter Foundation.
During Phase I of the SBIR grant, the researchers confirmed that as many as 250 human adult stem cells could remain viable in culture if they were encapsulated in a 200-micron-diameter bead made of natural algae materials and that they could release factors that enhance tissue regeneration.
“For the Phase II SBIR grant, we’re going to examine whether delivering microbeads full of stem cells can enhance cartilage repair and regeneration of craniofacial defects in an animal model,” said Boyan, who is the company’s chief scientific officer. Boyan is also the associate dean for research and innovation in the Georgia Tech College of Engineering, the Price Gilbert, Jr. Chair in Tissue Engineering at Georgia Tech, and a Georgia Research Alliance Eminent Scholar.
The company will perform this research in its laboratory space located in the Advanced Technology Development Center (ATDC) biosciences incubator.
The company’s ultimate goal is to commercialize the microbead technology for use in hospitals and by cell therapy companies. To help reach this goal, a group of students wrote a business plan for SpherIngenics last year through the Georgia Tech Scheller College of Business Technological Innovation: Generating Economic Results (TI:GER) program.
The team -- which included Coulter Department doctoral student Christopher Lee, Georgia Tech MBA students Chris Palazzola and Eric Diersen, and Emory University law students Bryan Stewart and Natalie Dana -- won third place in the 2011 Georgia Tech Business Plan Competition. The competition, while largely an education experience, provided students an opportunity to develop their venture ideas and present them to a panel of highly experienced judges in the venture capital, technology transfer and legal fields.
“The TI:GER team’s business plan helped us learn about where the market for our technology is right now and where it is going in the future, which is extremely valuable knowledge as we work toward determining the most promising pathway to market,” said Bost.
Additional members of the company include Anthony Nicolini, the principal investigator on the Phase II SBIR grant, and Joseph Williams, clinical director of craniofacial plastic surgery at Children’s Healthcare of Atlanta at Scottish Rite and clinical assistant professor in the Department of Plastic and Reconstructive Surgery at Emory University.
Research reported in this publication was supported by the U.S. Army Medical Research and Materiel Command under award numbers W81XWH-07-1-0219 and W81XWH-11-C-0071. The content is solely the responsibility of the principal investigators and does not necessarily represent the official views of the U.S. Government.
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]]>In addition, Dr. Phelps provides clinical input into safety and regulatory interactions and assists with the development of global collaborations that integrate broad medical, scientific, and commercial concepts into the program. These efforts are designed to shepherd the transition of viable ideas into useable products across and between the fields of medicine, technology and science.
“We are excited to have someone of Dr. Phelps’ broad clinical expertise as part of our leadership team” said Barbara Boyan, Executive Director of TRIBES and the Price Gilbert, Jr. Chair in Tissue Engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory and Associate Dean for Research and Innovation for Georgia Tech’s College of Engineering.
In addition to his role as TRIBES Medical Director, Dr. Phelps serves as the Director of Health Systems Technology Research and Development at the Georgia Tech Research Institute where he manages and facilitates health-related technological synergies internally and externally.
Dr. Phelps retired in March 2011 from the U. S. Army with over 30 years of total active federal service. He started in the military as a Special Forces Senior Non-Commissioned Officer. Following his commission, he completed medical school and residency and retired as a Lieutenant Colonel in the Medical Corps. His duties included planning, supporting, and/or directing numerous Department of Defense research and development projects totaling over $150 million.
Widely regarded as an expert on a variety of special operations/operational medicine, injury biomechanics and wilderness medicine topics, he currently focuses on research into the cause, prevention, and development of applied solutions to human injury. He is certified as both a Senior U.S. Army and U.S. Navy Flight Surgeon/Aerospace Medicine physician, and is a distinguished Fellow of the American Academy of Family Physicians.
The Translational Research Institute for Biomedical Engineering and Science (TRIBES) links biomedical research and educational activities at Georgia Tech with key medical institutions and organizations for the benefit of diagnosis and treatment of patients in the healthcare system. TRIBES provides critical capabilities to pre-commercial engineering development activities for the license and transition of technology into industry.
TRIBES is part of the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University and includes three centers directed by Boyan – the Center for Advanced Bioengineering for Soldier Survivability, the Center for Pediatric Healthcare Technology Innovation and the Atlanta Pediatric Device Consortium.
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http://www.fredericknewspost.com/sections/news/display.htm?StoryID=117923
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RELATED LINKS
http://www.nature.com/nm/journal/v16/n9/full/nm0910-948.html
http://www.boyanlab.gatech.edu
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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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More about this news: http://mgt.gatech.edu/news_room/news/2011/articles/SpherIngenics.html
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Organizers of the recently established Georgia Tech Center for Advanced Bioengineering for Soldier Survivability want to change that.
"The goal of the center is to rapidly move new technologies from the laboratory to patients so that we can improve the quality of life for our veterans as they return from the wars the United States is fighting," said center director Barbara Boyan, the Price Gilbert, Jr. Chair in Tissue Engineering at the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.
The center will leverage the expertise of Georgia Tech researchers in musculoskeletal biology and regenerative medicine to quickly move tools that are clinically valuable, safe and effective from laboratories to use in trauma centers. To reduce the amount of time from invention to clinical use, engineers and scientists in the center work in teams that include a clinician with experience in combat medical care and a medical device industry partner.
Support for the center is provided by the Armed Forces Institute of Regenerative Medicine, the U.S. Army Institute of Surgical Research's Orthopedic Trauma Research Program, the U.S. Department of Defense and industry.
Researchers in the center will initially focus on ways to improve the healing of wounds, segmental bone defects and massive soft tissue defects. Traumatic injuries that affect the arms, legs, head and neck require technologies for treatment at the time of injury and in the ensuing days and months.
"These combat injuries are complicated to treat because they are large and typically infected, so even determining when a soldier should be treated for optimal recovery is a challenge," said Boyan, who is also the associate dean for research in Georgia Tech's College of Engineering and a Georgia Research Alliance Eminent Scholar. "It is not known whether a regenerative therapy will be most effective if used immediately following injury or at some later time after scar tissue has been established at the wound site."
By developing models that accurately reflect the complex aspects of injuries sustained by soldiers in combat, the researchers will be able to test assumptions about when to employ specific strategies and how to ensure their effectiveness. The models must also allow them to examine the use of technologies on both male and female patients, and on complex tissues that consist of nerves, a blood supply and multiple cell types.
"Since the processes of bone, vascular and neural formation are naturally linked during normal tissue development, growth and repair, our approach is to harness this knowledge by developing delivery strategies that present the right biologic cues in the right place at the right time to promote functional regeneration of multiple integrated tissues," said associate director of the center Robert Guldberg, a professor in Georgia Tech's Woodruff School of Mechanical Engineering.
To enhance tissue repair and regeneration following a traumatic injury, the researchers are focusing their efforts on stem cells. Even though stem cells have tremendous potential for repairing such defects, effective methods do not yet exist for delivering them to an injury site and of ensuring that they survive and remain at that site long enough to impact the regeneration process.
"Clinicians currently inject stem cells into a vein and hope that the cells will migrate to sites of injury and remain at those sites long enough to participate in the repair process. While some cells certainly do migrate to injury sites, the actual percentage is very small and those that arrive at the site do not remain to engraft with the host tissue," explained Boyan.
This limited effect may be the result of the injection process, according to Boyan, so researchers in the center are developing ways to protect the cells from damaging forces they might encounter when inserted into the body.
"Studies in our laboratory have shown that when stem cells are encapsulated in microbeads, they can be injected by needle without loss of cell viability and they remain at the injury site for at least two months," said Boyan.
Protecting the cells during insertion is just the first step toward improved tissue repair. The researchers must also examine whether the stem cells will turn into cells typical of the implanted tissue and if they produce or should be paired with molecules that can enhance the healing of the implanted tissues.
Center researchers are also investigating whether bone marrow-derived stem cells can be used in the body to heal large defects in bone and cartilage if they are inserted in fiber mesh scaffolds and silk sponges during a surgical procedure.
Additional projects in the center include assessing tissue viability, preventing the growth of bone in the soft tissues of the body and improving pre-hospital care of orthopedic injuries. Since effective treatment of traumatic injuries is an important goal for the general public as well as the military population, the researchers also hope to adapt their technologies for use in hospitals.
Other researchers in the center include Ravi Bellamkonda, a professor in the Coulter Department; Andres Garcia, the Woodruff Faculty Fellow in the Woodruff School of Mechanical Engineering; Robert Taylor, a professor in the Coulter Department and Emory's Division of Cardiology; Zvi Schwartz, a visiting professor in the Coulter Department; and U.S. Army surgical medicine consultants Michael Yaszemski and David Cohen.
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