May 28 – 30, 2011 at The Cloister at Sea Island, Georgia. For more information, visit Georgia Neurosurgical Society.
Archive for May, 2011
May 26, 2011 at the 5 Seasons Brewery at The Prado in Sandy Springs. For more information, visit Medical Association of Atlanta.
Pediatricians Eric Felner, MD, MSCR, and Mark Rigby, MD, PhD, have launched a phase II multi-center clinical trial evaluating whether intramuscular injections of alefacept (Amevive®) halt or slow the destruction of insulin-producing beta cells in the pancreas of patients recently diagnosed with Type 1 diabetes. Rigby is the trial’s national program director and both serve as the co-lead investigators at the Emory and Children’s Healthcare of Atlanta site.
The clinical study, the Research Trial of Inducing Remission in New-Onset Type 1 Diabetes with Alefacept (T1DAL), will test the ability of alefacept to reduce the activity of T cells and protect the residual beta cells in individuals newly diagnosed with Type 1 diabetes from ongoing autoimmune destruction.
“This project brings together key basic and clinical discoveries in many fields inside and outside Type 1 diabetes research, over many decades,” says Rigby, an assistant professor of pediatrics and surgery in the Emory University School of Medicine and a physician at Children’s Healthcare of Atlanta.
Once called juvenile diabetes, Type 1 diabetes does not just occur in children. It refers to a form of diabetes mellitus that is the result of an autoimmune disorder. In those with diabetes, T cells destroy the beta cells, the insulin-producing cells residing in the pancreas. Insulin is needed to maintain normal levels of blood glucose, which in turn, allows cells to function normally. When Type 1 diabetes is initially diagnosed, it is believed that a substantial number of beta cells in the pancreas are still viable and continue to produce a small amount of insulin, but production lessens over time.
Although alefacept has never been tested in patients with diabetes, it has already been approved by the FDA for use in treating plaque psoriasis. Both Type 1 diabetes and psoriasis are chronic autoimmune diseases involving T cells, which normally protect the body from infections. T cells are exquisitely important for protective immunity against viruses and bacteria. In fact, if a person’s T cell count falls, he or she is susceptible to opportunistic infections. However, in Type 1 diabetes and psoriasis, overactive or renegade T cells end up damaging other cells. In the case of psoriasis, T cells attack the skin, causing lesions and scaling.
“In T1DAL, we are targeting what we believe to be the most damaging, rogue immune cells in the body that are actively involved in the destruction of beta cells early on in Type 1 diabetes,” says Rigby. “Due to alefacept’s use in the treatment of another immune-based disease and the safety profile established with that illness, we are confident the drug will have minimal impact on the protective aspects of the immune system. We believe that this study is one critical step in the path to finding a cure for this disease.”
Felner himself was diagnosed with Type 1 diabetes in 1978 at Egleston Children’s Hospital. He is now an associate professor of pediatrics in the Emory University School of Medicine and a physician at Children’s Healthcare of Atlanta. Since his diagnosis he has managed to control the diabetes with insulin therapy, including use of a continuous insulin pump for the past 11 years. Despite this, he says his diabetes is still not cured.
“I have been caring for children with Type 1 diabetes for almost 15 years and these studies are finally providing hope of finding a cure,” says Felner.
The T1DAL trial is seeking 66 eligible participants at approximately 15 clinical research centers nationwide including Emory and Children’s Healthcare of Atlanta. Participants must be between the ages of 12 to 35 years and must have been diagnosed with Type 1 diabetes mellitus within 100 days of enrollment in the trial. Enrollment is expected to continue for approximately two years.
Eligible participants will be randomly assigned to receive weekly intramuscular injections of alefacept or a placebo for two 12-week periods.
According to Rigby, at least 80 to 90 percent of people who develop Type 1 diabetes are children. “We know that there are up to two million people in North America who have Type 1 diabetes. About 30,000 people a year develop it. And just in Atlanta, there are probably 400 children who will develop the disease every year. Every day there’s another child diagnosed–that’s another way to think about it.”
The T1DAL trial is being conducted by the Immune Tolerance Network (ITN) and is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Additional funding for the study is provided by the Special Statutory Funding Program for Type 1 Diabetes Research, a special appropriation for research on the prevention and cure of Type 1 diabetes. Astellas Pharma US Inc. is providing the Amevive® for the study.
In addition to the current study, Rigby and Felner have been leading two others. The first trial, START, involves Thymoglobulin®, a mixture of antibodies that attaches itself to T cells, temporarily eliminating a large proportion of them from the bloodstream, with the hope that new T cells that replace the old T cells will learn to accept the beta cells rather than attacking them. This trial officially closed on March 31, 2011, but follow-up for these patients will continue for two years after they enrolled.
The second study, RETAIN, is a two-part trial investigating the effect of intravenous Alpha-1 antitrypsin (AAT, Aralast NP) on preserving beta cell function and whether AAT will help slow the progression of Type 1 diabetes. This trial is still recruiting.
More information about the T1DAL trial and participating clinical research centers can be found at www.t1dal.org or http://www.clinicaltrials.gov/ct2/show/study/NCT00965458. Or you may e-mail Type1diabetes@emory.edu or call 404-785-T1DM (8136) to contact Emory directly.
The trials are part of the Clinical and Translational Research Center – one of 14 priority centers in the Emory-Children’s Pediatric Research Center led by Emory University and Children’s Healthcare of Atlanta. The Clinical and Translational Research Center is currently recruiting new faculty and staff.
The other centers include hematology and oncology; immunology and vaccines; transplant immunology and immune therapeutics; pediatric healthcare technology innovation; cystic fibrosis; developmental lung biology; endothelial biology; cardiovascular biology; drug discovery; autism; neurosciences; nanomedicine; and outcomes research and public health.
Henry Medical Center (HMC) announced the selection of Piedmont Healthcare to be its health care partner. This decision was made today by the Hospital Authority of Henry County, the Henry Health Systems Board and the Henry Medical Center Board of Directors.
The selection comes after a nine-month structured and competitive process conducted by an Affiliation Steering Committee, consisting of members from all three hospital boards, medical staff leadership and hospital administration. The work done by the Affiliation Steering Committee has been extensive with detailed evaluation of both organizations after the field was narrowed from seven candidates to two finalists including extensive review of data and other information, multiple presentations and meetings, and site visits made to affiliated hospitals.
“We are very fortunate to have two outstanding organizations to choose between,” said Jeff Mills, Chairman of the Affiliation Steering Committee and Vice-Chairman of the Henry Medical Center Board of Directors. “It was a difficult decision, considering the excellent credentials both candidates presented. I am confident that the process we used to evaluate the candidates and make our decision was thorough, analytical, and based on what we believe to be in the best interests of Henry Medical Center and our community.”
According to Henry Medical Center President & CEO Charlie Scott, Piedmont Healthcare was selected based on its community hospital focus and experience; its demonstrated record of improving community hospitals in the areas of quality, patient and employee satisfaction, clinical program development, capital investment, and financial standing; its clear and close alignment with Henry Medical Center’s mission and culture; and its existing and proven clinical integration strategy.
The three boards also decided on a long-term lease as the structural model for the affiliation, as opposed to an outright sale. Although the details remain to be worked out, according to this model the hospital assets would continue to be owned by the Hospital Authority and leased to Henry Medical Center, which would become a subsidiary of Piedmont Healthcare who would have the responsibility and authority to operate the hospital. In addition, the final agreement will provide that the 1 mil tax levy will be eliminated and that Piedmont will be the guarantor on the existing bonds.
This partnership will allow the hospital to strengthen its ability to serve its community while meeting the many challenges happening in health care. According to Henry County Board of Commissioner Chair B.J. Mathis, “Henry County and Henry Medical Center are fortunate to be affiliating with such a quality health care organization. Our residents are key stakeholders in this affiliation and we look forward to seeing this progress and are pleased to welcome them to our community.”
“Today is a great day not only for quality health care for our citizens, but also for economic development in Henry County,” said Kay Pippin, Henry County Chamber of Commerce President. “A partnership between HMC and Piedmont will be highly beneficial for our citizens and businesses.”
The benefits of affiliation include, but are not limited to, assistance in enhancing quality of care and customer service, developing and expanding clinical services, achieving economies of scale and improved purchasing power, and access to capital and other valuable resources. “We are very excited about the prospect of a long-term partnership with Piedmont Healthcare and the many benefits it will bring to the delivery of healthcare in Henry County and the surrounding area,” said Steve Kay, Chairman of the Henry Medical Center Board of Directors and the Hospital Authority of Henry County. “We eagerly look forward to completing the transaction process and becoming a proud member of Piedmont Healthcare.”
The two health care organizations will promptly begin formal negotiations to develop a definitive agreement for the affiliation. The agreement will also need to be reviewed and approved by the State Attorney General’s office. These steps will likely take a number of months to accomplish.
More than 400 physicians, researchers, scientists, engineers, physicists and others, representing 39 states and 41 countries, attended the first-ever World Symposium on Endometriosis, March 24-26, 2011, at the Intercontinental Hotel in Atlanta. Sponsored by Northside Hospital, the event featured late-breaking science, presented by some of the world’s leading experts on endometriosis; open forum discussions to further explore treatment and diagnosis options in the management of this disease; live surgery transmissions from hospitals around the world; hands-on training to educate attendees in the art and science of laparoscopic suturing and knot tying; and much more.
“This gathering explored historical, diagnostic and therapeutic possibilities and treatment of endometriosis,” said Dr. Ceana Nezhat, chair of the Department of Obstetrics and Gynecology at Northside Hospital and chair of the 2011 World Symposium. “As the title “From Molecules to Robotics” reflects, therapeutic options from immunology to the use of robots in treatment of this enigmatic disease were discussed.”
Endometriosis is one of the most misunderstood afflictions in women’s health, affecting more than 70 million women of child-bearing age, including young girls, worldwide. While the lifetime incidence of developing breast cancer in the U.S. is one in eight women and one in 72 for ovarian cancer, it is estimated that one in seven women will develop endometriosis. Annual costs of the disease reached $22 billion in the U.S. in 20021. Symptoms can include pain, irregular bleeding and infertility, among others. In fact, incidence of endometriosis has been found in approximately 30 to 40 percent of infertility cases. If left untreated, it can progress and cause severe medical problems including organ damage and eventual loss of function.2
“I have treated endometriosis in women of all ages, as young as 12 years old,” said Dr. Nezhat. “This symposium was the first gathering of its caliber and I believe it will set the foundation for future meetings and collaborative work.”
Transplant and reconstructive surgeons from Emory University Hospital successfully performed a rare complete hand transplant on 21-year-old.
The 19-hour surgery took place on Saturday, March 12 and involved multiple teams of surgeons, anesthesiologists, nurses, and operating room support staff. Two teams – one dedicated to the patient – and the other to the donor arm – successfully completed the surgery at approximately midnight.
The intricate surgery involved the connection of numerous structures including bones, tendons, nerves, vessels and finally the skin. The patient was placed in a protective splint for 48 hours and is now wearing a high-tech brace that supports the limb while she begins the long process to gain function of her new hand.
Following the surgery, Lu began rehabilitation at Emory. At the news conference she said she understands that it will never be a normal hand, but not having a left hand since she was an infant, “I expect it to help in simple everyday activities.” She went onto say “right now I am filled with emotions and I don’t think that there is really anything that can describe how I feel, other than just happiness, hopefulness and of course thankfulness.”
“This is an exciting time for our patient, her family, and the reconstructive community in general. Ms. Lu is doing very well. She is referring to her transplant as ‘my hand,’” says Linda Cendales, MD, Assistant Professor of Surgery at Emory University School of Medicine.
The Emory University-Veterans Affairs Vascularized Composite Allograft (VCA) Program was created in late 2007 with the recruitment of Dr. Cendales who has worked to develop one of the nation’s premier centers for reconstructive transplantation. This case is among the small number of hand transplants that have been successfully performed in the U.S. and puts Emory among only four centers to have successfully performed the procedure. The first hand transplant in the U.S. took place in Louisville at the center where Dr. Cendales trained, and where in 1999, she was on the team that performed the nation’s first hand transplant.
The program at Emory and the Atlanta Veterans Affairs Medical Center was spurred by a grant from the Department of Defense administered through the Navy Bureau of Medicine and Surgery’s Medical Development Program with the strong backing of U.S. Senator Saxby Chambliss (R-Ga.).
“This represents a great success for Emory and for medicine,” says Sen. Chambliss. “The procedure they have demonstrated will benefit many people including members of our military who have suffered from injuries in Iraq, Afghanistan and elsewhere. I am proud and grateful for the dedicated leadership, physicians, and researchers at Emory who made this extraordinary breakthrough possible.”
The first hand transplant in the world was performed in 1964 in Ecuador, before the development of modern immunosuppressive medications. The recipient, a sailor, had to have the transplanted hand amputated two weeks after surgery because of tissue rejection. The next hand transplant was performed in France in 1998 and endured more than two years before the recipient stopped taking immunosuppressive medication and asked to have the hand removed.
The Louisville team’s first hand transplant is currently the longest surviving hand transplant in the world. Dr. Cendales was also involved in the team’s second hand transplant in 2001.
Surgeons have already tackled many of hand transplantation’s technical challenges, Dr. Cendales says. Issues involved in reattaching a severed limb, such as dealing with crushed bone or mangled connective tissue can make “replantation” more technically demanding than an organ transplant, she says. But vascularized composite transplantation continues to advance by leaps and bounds, with recent reports from around the world of transplants including faces, trachea, and larynx.
Below is a video of the press conference.
WellStar Medical Group announced the opening of WellStar’s first allergy and immunology practice, WellStar Medical Group Allergy & Immunology. Grace Chiang, M.D. will be heading up the clinic.
Dr. Chiang graduated Phi Beta Kappa and received her doctorate of medicine from the University of Wisconsin. She then completed her residency in pediatrics at St. Louis Children’s Hospital, followed by an allergy/immunology fellowship at Washington University in St. Louis. Prior to joining WellStar Medical Group, she cared for patients in the Atlanta area in private practice. Dr. Chiang is board-certified in allergy/immunology and pediatrics.
The practice will see patients of all ages, with conditions such as asthma, allergic rhinitis (hayfever), sinusitis, eczema, food allergies, insect allergies, hives, anaphylaxis, and other allergic conditions.
Physicians and engineers within a new center devoted to pediatric nanomedicine will develop targeted, molecular-sized nanoparticles as part of a unique approach to treating pediatric diseases. Specific focus areas will include pediatric heart disease and thrombosis, infectious diseases, cancer, sickle cell disease and cystic fibrosis. The Center for Pediatric Nanomedicine (CPN) is the first of its kind in the world.
Nanomedicine involves the development of engineered nanoscale structures and devices for better diagnostics and highly specific medical interventions to treat diseases and repair damaged tissues. One nanometer is one billionth of a meter, and the nanoscale is typically on the order of 1-100 nanometers.
Directed by Gang Bao, PhD, the center will involve researchers from Emory University, the Georgia Institute of Technology and Children’s Healthcare of Atlanta. Bao is the Robert A. Milton Professor of Biomedical Engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.
“Because nano-scale structures are compatible in size to biomolecules, nanomedicine provides unprecedented opportunities for achieving better control of biological processes and drastic improvements in disease detection, therapy and prevention,” says Bao.
The CPN is part of the Emory-Children’s Pediatric Research Center led by the two institutions, including partnerships with Georgia Institute of Technology and Morehouse School of Medicine. With the leadership of Paul Spearman, MD, Children’s chief research officer and vice chair for research in the Emory University Department of Pediatrics, 14 key priority centers have been identified. These are hematology and oncology; immunology and vaccines; transplant immunology and immune therapeutics; pediatric healthcare technology innovation; cystic fibrosis; developmental lung biology; endothelial biology; cardiovascular biology; drug discovery; autism; neurosciences; nanomedicine; outcomes research and public health; and clinical and translational research.
Emory and Georgia Tech already have had significant and successful research partnerships in nanomedicine funded by the National Institutes of Health. These have included nanotechnology center of excellence for the detection and treatment of cardiovascular disease, the development of personalized and predictive oncology, and the development of engineered protein machines for treating single-gene disorders.
“Nanotechnology can be applied to many diseases, and the application of nanotechnology could have a profound impact on improving children’s health,” says Bao.
Current centers located in the joint Georgia Tech-Emory biomedical engineering department include the Center for Translational Cardiovascular Nanomedicine (funded by a $14.6 million, five-year grant from NHLBI/NIH) and the Nanomedicine Center for Nucleoprotein Machines (funded by a $16.1 million, five-year grant from NIH).
The discoveries made in these centers also will be applied to research in pediatric diseases. For example, scientists in the center for nucleoprotein machines are focused on developing a technology to correct single-gene defects that lead to human disease. They hope to use this approach to treat and eventually cure sickle cell disease, first focusing on curing a mouse model of sickle cell. The new technology would then be applied to human sickle cell patients.
“Nanomedicine is expected to dramatically exceed what has occurred in the field thus far, and our belief is that it will revolutionize medicine,” says Bao. “We plan to make this new pediatric nanomedicine center a leader in applying these unique discoveries to treating and curing children’s diseases.”
Craig Mines, M.D. is an orthopedic surgeon and sports medicine specialist. He graduated from Albany Medical College and was certified by the American Board of Orthopedic Surgery in 2002. Dr. Mines provides sports medicine to local high schools and serves as volunteer medical director for the Atlanta Fire Hockey Program, evaluating player injuries.
Dr. Mines recently began prescribing The BioniCare Knee System and OActiveTM Knee Brace. BioniCare has provided patients the opportunity to regain mobile and active lifestyles, including running, walking, jogging and every day activities, while treating the symptoms associated with osteoarthritis of the knee.
Created by VQ OrthoCare, The BioniCare Knee System was cleared by the FDA in 2003 and is a non-surgical, non-pharmaceutical alternative treatment option for osteoarthritis of the knee. BioniCare delivers a low-level pulsed electrical signal to the knee held in place on the inside of a joint unloading brace, mimicking the naturally occurring signal present in a healthy knee joint. Unlike a standard knee brace, the BioniCare device is integrated into the OActive “unloader” knee brace to reduce the impact of body weight on the knee and alleviate the patient’s pain. BioniCare patients are under the care of a physician at all times and, on average, patients using the BioniCare Knee System and OActive Knee Brace have reported experiencing positive results after 750 hours.
Dr. Mines’ orthopedic practice, Eastside Orthocare, LLC, is located in Snellville, Georgia.