UPMC Physician Resources

NCI Renews SPORE Grant of More than $12 Million for Melanoma, Skin Cancer Research at UPCI

PITTSBURGH, Nov. 12, 2013 – The University of Pittsburgh Cancer Institute (UPCI) Melanoma and Skin Cancer Program (MSCP) led by John Kirkwood, M.D., has received renewal of its skin cancer research through the National Cancer Institute’s competitive Specialized Program of Research Excellence (SPORE) program. The grant is for more than $12 million.

The award is the fourth grant awarded to UPCI through the prestigious SPORE program, which requires cancer institutes to document strong collaboration between eminent scientists and clinicians as well as outstanding programs in translational research. The other three grants at UPCI are in head and neck, lung and ovarian cancers.

The SPORE grant for skin cancer will fund three new projects and the expansion of one prior project. These include:

  • Biomarkers of the proinflammatory response and elements of immune suppression: The goal of this project is to find biomarkers in melanoma patients at diagnosis or early in the disease that may predict the benefit of treatment with the drugs ipilimumab or interferon-α (IFNα) for each individual, as well as to assess the risk of melanoma recurrence and death. This effort continues earlier research that revealed biomarker patterns associated with pro-inflammatory immune responses and with immunosuppression in both tumor tissue and circulating blood.
  • Multiple antigen-engineered dendritic cell immunization and IFNα-2b boost for vaccine immunotherapy of metastatic melanoma: This project tests an improved dendritic cell vaccine targeting tumor antigens given in combination with IFNα-2b with the aim of boosting the immune response against the cancer.
  • Safety and efficacy of vemurafenib and high-dose IFNα-2b for advanced melanoma: This project will test whether vemurafenib, a drug that inhibits a signaling protein called BRAF, can enhance the therapeutic efficacy of IFNα-2b in patients with metastatic melanoma. In earlier work, the team found BRAF inhibitors make melanoma cells more sensitive to the effects of IFN-α, suppressing cell proliferation and encouraging apoptosis, or programmed cell death; increase T cell-mediated immune responses to melanoma cells; and prolong the survival of mice in a model of melanoma.
  • A microneedle vaccine program for immunotherapy of melanoma and cutaneous T cell lymphoma

Dr. Kirkwood’s melanoma research team first received SPORE funding five years ago and the grant’s five past projects have focused on immune approaches to treatment of melanoma and other skin cancers. The incidence of melanoma continues to rise dramatically. There has not been effective therapy to improve overall survival for the majority of patients with inoperable metastatic disease, although progress in the molecular therapy and immunotherapy of melanoma now has improved prospects for patients with melanoma considerably.

“We want to improve our understanding of the molecular and immunologic mechanisms underlying melanoma progression and to validate prognostic and predictive biomarkers that will lead to the personalized treatment of melanoma and other skin cancers,” Dr. Kirkwood said. “Our research is unique because we have integrated an approach that includes experts in melanoma from medical oncology, dermatology, surgery, immunology, biostatistics, bioinformatics, and biomarker discovery.”

Nancy E. Davidson, M.D., director of UPCI and its clinical partner, UPMC CancerCenter, called the SPORE grant a “perfect storm” in that it combines UPCI’s long-term scientific and clinical expertise in melanoma and immunology with the activities of the Department of Dermatology under the leadership of Louis Falo, M.D., Ph.D., and is tightly linked to national and international clinical trials activities in the cooperative groups.

“Multidisciplinary care is at the crux of modern cancer medicine and is critical for scientific discovery and translation,” Dr. Davidson said. “This SPORE grant is a great example of that.”

About 76,000 new cases of melanoma are diagnosed every year in the United States and about 9,400 people will die every year from the disease, according to the National Cancer Institute.

Dr. Kirkwood said the work being done through the SPORE grants is already making a difference. There have been several new therapies for melanoma approved since 2011, compared to just three agents approved in the 30 years prior.

UPMC Hospitals Earn Nation’s Top Quality Ratings for Heart Surgery

PITTSBURGH, Nov. 7, 2013 – UPMC Presbyterian and UPMC Shadyside have received the highest score for coronary artery bypass surgery from the Society of Thoracic Surgeons (STS), placing them in the top 13 percent of hospitals in the nation. UPMC Shadyside also received the highest “three stars” for aortic valve replacement surgery, ranking it in the top 6 percent of hospitals. The ratings are based on data compiled and publicly reported for the fiscal year 2013.

The STS’s three-star score designates that results are statistically better than the national average, based on a review of nearly 750 hospitals in the United States. UPMC Shadyside is one of only 23 hospitals in the nation to receive three stars in both aortic valve replacement and coronary artery bypass procedures for the last two reporting periods.

“The cardiac program is bringing the latest research and technologic innovations to our patients, including robotic surgery and trans-catheter heart valve therapy. These results reflect our commitment to excellence in patient care, of which we are very proud,” said Victor Morell, M.D., director of cardiac surgery at the UPMC Heart and Vascular Institute.

The STS National Database was established as an initiative for quality and safety improvement among cardiothoracic surgeons. The database covers three areas of cardiothoracic surgery—adult cardiac, general thoracic and congenital heart surgery.

Pitt Public Health Analysis Challenges Assumptions About Bisexual Men and HIV Transmission

BOSTON, Nov. 6, 2013 – The number of HIV positive men who have sex with both men and women is likely no higher than the number of HIV positive heterosexual men, according to a U.S.-based analysis by University of Pittsburgh Graduate School of Public Health researchers. The finding challenges a popular assumption that bisexual men are responsible for significant HIV transmission to their female partners.

The research, which will be presented today at the American Public Health Association’s 141st Annual Meeting & Exposition in Boston, builds a case for federal investment in research on HIV prevalence among bisexually behaving men.

“Some observers have exaggerated the idea of viral ‘bridging’ – where a bisexual man contracts HIV from another man and then transmits it to a female partner. But, at least in the U.S., the data supporting the extent of this is quite limited,” said Mackey R. Friedman, Ph.D., M.P.H., of Pitt Public Health’s Department of Infectious Diseases and Microbiology, who led the research.

Currently, the U.S. Centers for Disease Control and Prevention (CDC) does not report on HIV data specific to bisexually behaving people, though it does report data on homosexually and heterosexually behaving people, as well as injection drug users.

Dr. Friedman and his colleagues reviewed over 3,000 scientific articles to obtain data on HIV prevalence and risks among men who have sex with men only and men who have sex with men and women.

The bisexually behaving men were only 40 percent as likely to be infected with HIV as the homosexually behaving men. The researchers propose that this is because the bisexually behaving men reported lower rates of unprotected receptive anal intercourse, the biggest risk factor for HIV transmission among men in the U.S.

The analysis also estimates that there are approximately 1.2 million bisexual men in the U.S., of whom 121,800 are HIV-positive. That estimate aligns with CDC estimates for HIV infection in male heterosexuals and intravenous drug users.

Dr. Friedman, who has conducted HIV prevention and research for more than 15 years, believes that while bisexually behaving men may have a lower risk profile than homosexually behaving men, their HIV burden still warrants the development of targeted interventions.

“The HIV infection risk that bisexual men pose to their female partners has likely been overstated,” said Dr. Friedman. “However, that doesn’t mean that HIV-prevention campaigns targeting bisexual men and their male and female partners aren’t needed. HIV does exist in the bisexual community, and national, bisexual-specific data collection, research, and HIV prevention and care delivery are necessary to ameliorate this population’s HIV burden.”

Additional collaborators on this research are Chongyi Wei, Dr.P.H., Mary Lou Klem, Ph.D., Anthony Silvestre, Ph.D., Nina Markovic, Ph.D., and Ron Stall, Ph.D., all of the University of Pittsburgh.

David Perlmutter, MD, Gives Hans Popper State-of-the-Art Lecture

On November 3, David H. Perlmutter, MD, delivered the Hans Popper State-of-the-Art Lecture as part of the American Association for the Study of Liver Diseases (AASLD) conference in Washington, DC. The Popper lecture is a keynote address at the annual meeting of AASLD and this year’s meeting occurred on the 50th anniversary of the discovery of alpha-1-antitrypsin deficiency.  Dr. Perlmutter was selected because he is an internationally recognized leader in the liver disease caused by this deficiency and has recently developed several new drug treatment strategies.

The lecture was entitled, Alpha-1 Antitrypsin Deficiency: Novel Treatment Strategies Fifty Years After Discovery, and described the history of the disease, what we have learned about its unique clinical sequellae, and novel treatment strategies that have originated from understanding the unique pathobiology.

David H. Perlmutter, MD, is the Vira I Heinz Endowed Chair of the Department of Pediatrics at the University of Pittsburgh School of Medicine. He is Distinguished Professor of Pediatrics and Professor of Cell Biology at the University and Physician-in-Chief and Scientific Director of Children’s Hospital of Pittsburgh of UPMC.

Dr. Perlmutter has carried out basic research on alpha-1-antitrypsin deficiency for over 25 years. His work has led to many new concepts about the pathobiology of liver disease in this deficiency and has suggested several new concepts for chemoprophylaxis of chronic liver injury, hepatocellular carcinoma and emphysema in this genetic disease.

In 2010 he discovered a new pharmacological strategy that prevents liver damage in a mouse model of alpha- 1-antitrypsin deficiency and that strategy is now being tested in Phase II/III clinical trials. In his lecture he talked about how the first drug in the category of autophagy enhancers, carbamazepine, is being tested in individuals from 14 to 75 years of age with severe liver disease caused by alpha-1-antitrypsin deficiency.

He also talked about several other new drugs that have been discovered by his lab and a team of collaborators at University of Pittsburgh that are FDA-approved and can soon be tested in patients with this disease.  He emphasized that alpha-1-antitrypsin deficiency is the most common genetic cause of liver disease in children and that it is a much more common cause of cirrhosis and hepatocellular carcinoma in adults than previously recognized.  Indeed it appears that the peak age for this liver disease is between 50 and 65 years of age.  The autophagy enhancer drugs currently being tested or in the pipeline give great hope that we will be able to effectively prevent the progression of this devastating liver disease in the near future.

For more about Dr. Perlmutter’s work, please visit his profile here.

For a complete listing of UPMC and the University of Pittsburgh physicians and experts involved with the 2013 AASLD meeting, click here.

Compounded Medication to Prevent Preterm Birth Not a Safety Risk, Pitt Study Confirms

PITTSBURGH, Nov. 4, 2013 – A new study published online today in the American Journal of Obstetrics and Gynecology by researchers from the University of Pittsburgh School of Medicine and the University of Pittsburgh School of Pharmacy reports that 17-hydroxyprogesterone caproate (17-OHPC), a medication that reduces the rate of preterm birth in high-risk women, did not raise any safety concerns when the medication was prepared and dispensed by independent compounding pharmacies throughout the United States.

17-OHPC has been proven to reduce the risk of preterm births in women with a clinical history of early delivery by one-third. Until recently, this medication was available only from independent compounding pharmacies with a cost of $10 to $15 per injection. A pharmaceutical company in February 2011 received FDA approval to license the medication under the name Makena and established the price at $1500 per injection. The public outcry that followed led the FDA to issue a statement that it would not enforce action against compounding pharmacies that continued to produce and provide the medication.

Since then, researchers from the company that markets Makena, published a report suggesting compounded 17-OHPC poses a risk to patients because of the potential for drug impurity and inconsistent potency. The FDA conducted its own study and could not identify any safety problems with the drug, but decided it would apply its normal enforcement policy on compounding the product.

Researchers from Pitt’s School of Medicine and School of Pharmacy conducted an independent study to determine the quality of 17-OHPC obtained from compounding pharmacies across the country. Specialists in treating high-risk pregnancy supplied a representative sample of the compounded 17-OHPC used in their practices. Eighteen samples of compounded 17-OHPC were obtained from 15 pharmacies and analyzed at Pitt.

“Contrary to the report provided by the company that markets Makena, we found that 17-OHPC from compounding pharmacies raised no safety concerns about drug potency, sterility or purity,” said Steve N. Caritis, M.D., professor of obstetrics and gynecology at Pitt, and the study’s corresponding author. Dr. Caritis cautioned, however, that the sample size was small and the findings cannot be applied to all compounded products or pharmacies.

“If a compounding pharmacy is used for preparation of 17-OHPC, a discussion with the pharmacy preparing the product is prudent, to assure production of a high-quality product,” Dr. Caritis said.

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, grant number HD047905.

In addition to Dr. Caritis, Pitt’s research team included Justine Chang, M.D., Yang Zhao, Ph.D., Wen Chen Zhao, M.S., and Raman Venkataramanan, Ph.D.

UPMC Expands the Use of Next-Generation Sequencing for Cancer Patients to Guide New Therapies

PITTSBURGH, Nov. 4, 2013 – In a move away from a one-size-fits-most approach to treating cancer, UPMC and the University of Pittsburgh are significantly expanding capabilities to use next-generation sequencing to provide personalized care for cancer patients. The program, initiated a year ago, has completed the analysis of 250 patients with advanced cancer who failed standard therapies, leading to new therapeutic targets and a more dynamic model of care for cancer patients.

In a newly expanded laboratory at the University of Pittsburgh, molecular pathologists are using a machine the size of a computer printer to sequence large regions of genome for patients suffering from late-stage lung, colon, breast and other common cancers. The team, under the direction of Yuri Nikiforov, M.D., Ph.D., vice chair of Pitt’s Department of Pathology and director of the Division of Molecular and Genomic Pathology, as of Nov. 1, will offer testing for UPMC patients with every cancer type and stage when there is clinical necessity.

“The genetic alterations that lead to the dysfunction of cancer‐related genes are important diagnostic, prognostic and predictive biologic markers. The newest technologies known as next-generation sequencing allow us to sequence numerous cancer genes at the same time, giving us valuable information about cancer mutations that can be targeted by new drugs, allowing for the use of personalized cancer therapies,” Dr. Nikiforov said.

The program uses the Personalized Cancer Mutation Panel (PCMP) developed at Pitt that can identify 2,800 mutations in 50 key cancer genes.

“The spike in interest in molecular testing is fueled by the growth of targeted drugs that can be used based on the results of tumor profiling, and the most comprehensive way to do it is using next-generation sequencing,” said George K. Michalopoulos, M.D., Ph.D., Maud L. Menten Professor of Pathology and chairman of the Department of Pathology.

To discuss this new information obtained from sequencing and the best way to use it for cancer patient care, a multidisciplinary genomic tumor board was established at UPMC CancerCenter that includes oncologists, pathologists and other physicians and scientists involved in cancer research.

Mark Socinski, M.D., director of the Lung Cancer Section of the Division of Hematology/Oncology at the University of Pittsburgh School of Medicine, co-director of the UPMC Center for Excellence in Lung Cancer and co-director of UPCI’s Lung and Thoracic Malignancies Program, participates in the tumor board and has seen first-hand how such sequencing can help patients. In one case, Dr. Socinski said, genetic sequencing helped identify new treatments for a 64-year-old suffering from lung cancer; scans done since the new treatments show the cancer isn’t growing.

Doctors and researchers caution that such advanced sequencing isn’t a cure-all for cancer, but it can offer the hope of new treatments for many patients.

“Genomics is not just the future of cancer care, but it’s happening right now,” said Nancy E. Davidson, M.D., director of the UPMC CancerCenter and University of Pittsburgh Cancer Institute (UPCI). “We’re taking what we learn directly from the bench to the bedside to help patients.”

UPMC Hospitals Earn Top Quality Recognition from The Joint Commission

PITTSBURGH, Nov. 4, 2013 – Six UPMC hospitals were named Top Performer on Key Quality Measures® by The Joint Commission, the leading accreditor of health care organizations in America. UPMC Bedford Memorial, UPMC Horizon, UPMC McKeesport, UPMC Mercy, UPMC Northwest and UPMC Passavant were recognized by The Joint Commission for exemplary performance in using evidence-based clinical processes that are shown to improve care for certain conditions.

There are 1,099 hospitals, or nearly half of The Joint Commission accredited hospitals in the nation, earning this distinction for attaining and sustaining excellence in accountability measures performance. The hospitals are recognized for their achievement on the following measure sets:

  • UPMC Bedford Memorial – Pneumonia, Surgical Care
  • UPMC Horizon – Heart Attack, Heart Failure, Pneumonia, Surgical Care
  • UPMC McKeesport – Heart Attack, Heart Failure, Pneumonia, Surgical Care
  • UPMC Mercy – Heart Attack, Heart Failure, Pneumonia, Surgical Care
  • UPMC Northwest – Heart Attack, Pneumonia, Surgical Care
  • UPMC Passavant – Heart Attack, Heart Failure, Pneumonia, Surgical Care

The ratings are based on an aggregation of accountability measures reported to The Joint Commission during the 2012 calendar year. Each measure represents an evidence-based practice, such as giving aspirin at arrival for heart attack patients and giving antibiotics one hour before surgery.

“Our continuing, systemwide efforts to provide our patients with the right care at the right time is reflected in this honor,” said Tami Minnier, chief quality officer at UPMC. “But more important than any award is the fact that evidence-based medicine is producing better care for patients at all of our hospitals.”

“UPMC and all the Top Performer hospitals have demonstrated an exceptional commitment to quality improvement and they should be proud of their achievement,” says Mark R. Chassin, M.D., F.A.C.P., M.P.P., M.P.H., president and chief executive officer, The Joint Commission. “We have much to celebrate this year. Nearly half of our accredited hospitals have attained or nearly attained the Top Performer distinction. This truly shows that we are approaching a tipping point in hospital quality performance that will directly contribute to better health outcomes for patients.”

Women Report Better Sexual Health after Weight-Loss Surgery, Researchers Find

PITTSBURGH, Nov. 4, 2013 Researchers measuring the changes in sexual function and sex hormone levels in women following bariatric surgery have found that, on average, women reported significant improvements in overall sexual functioning and satisfaction.

The findings are published online in the Nov. 4 issue of JAMA Surgery and will be presented on Nov. 14 at Obesity Week in Atlanta.

“Thirteen percent of the participants who reported sexual dysfunction before undergoing weight loss surgery saw dramatic improvement in function after surgery,” said Nicholas Christian, Ph.D., a biostatistician, Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, who analyzed the data for the study. “Another 53 percent saw a modest improvement, on average.”

The study used data collected from the Longitudinal Assessment of Bariatric Surgery (LABS) consortium, which has its data coordinating center at Pitt Public Health, and 10 hospitals with a large clinical center at Magee-Womens Hospital of UPMC. In particular, a subset of the data looks at the long-term effects of bariatric surgery on the weight of study participants, as well as on their physical and mental health.

Researchers recruited 106 of the women who were part of the larger LABS-2 study at the clinical sites in Pittsburgh and Fargo, N.D., to participate in this additional ancillary study. In addition to the LABS forms assessing quality of life and depression, the women answered questions focusing on their perception of their body image and their sexual health, and gave blood samples.

Sexual function significantly improved from before surgery to the first year post surgery. By the second year, women reported improvements in arousal, lubrication, desires and satisfaction. They also had significant improvements in sex hormone levels.

In addition to improved sexual function, the women reported significant improvements in quality of life, as well as body image and depression symptoms.

“Our results explore other important aspects of health and suggest that improvements in sexual functioning in women can be added to the long list of benefits seen in the first several years after bariatric surgery,” said co-author Anita Courcoulas, M.D., M.P.H., a bariatric and general surgeon at Magee-Womens Hospital of UPMC.

The study’s lead author is David Sarwer, Ph.D., Department of Psychiatry, University of Pennsylvania. Additional authors include Jacqueline C. Spitzer, M.S.Ed., and Thomas A. Wadden, Ph.D., of the University of Pennsylvania; James E. Mitchell, M.D., and Kathryn Lancaster, B.A., both of the University of North Dakota; William Gourash, M.S.N., C.R.N.P., of UPMC; and Raymond C. Rosen, Ph.D., of the New England Research Institutes.

The ancillary study to the LABS-2 was funded by the National Institute of Diabetes and Digestive and Kidney Diseases grant RO1DKO72452.

Pitt Public Health Professor Receives National Faculty Award

BOSTON, Nov. 4, 2013 – Margaret Potter, J.D., M.S., professor of health policy and management at the University of Pittsburgh Graduate School of Public Health, yesterday was awarded a 2013 Association of Schools and Programs of Public Health (ASPPH)/Pfizer Faculty Award at the ASPPH Annual Meeting.

The “Faculty Award for Excellence in Academic Public Health Practice” is a national award that honors graduate public health faculty who are notable for their teaching, practice and research excellence.

“This award is a great honor for me,” said Ms. Potter, also the associate dean for public health practice and the director for the Center for Public Health Practice at Pitt Public Health. “But it’s also a great way to recognize how valuable professional-practice relationships and experience are to public health education and research.”

The award was presented at the meeting in Boston during a session titled “Public Health Leadership for a Healthy America.” Ms. Potter’s selection for this award was based, in part, on her national leadership in translating public health scholarship to improve public health systems, thereby improving the general population’s health and well-being.

Ms. Potter has served as chair of the board of the Public Health Foundation, was a member of the Model Design Working Group for the National Health Security Preparedness Index project and currently chairs the Pennsylvania Advisory Committee on Public Health Laws.

She was an advisor to the Health Resources Services Administration in creating the Public Health Training Centers. After the terrorist attacks of Sept. 11, 2001, she led the Center for Public Health Preparedness at Pitt Public Health with funding from the U.S. Centers for Disease Control and Prevention. Later, she led a consensus panel that assessed the effectiveness of training health professionals for emergency preparedness and response.

Her practice-based research has spanned a broad range of topics, including public health systems, law and policy, and use of computational modeling in preparedness research.

Ms. Potter earned a J.D. from the Rutgers-Newark School of Law and a master’s degree in biomedical science information from the Illinois Institute of Technology.

Low Vitamin D Levels During Pregnancy Associated with Preterm Birth in Non-White Mothers

PITTSBURGH, Oct. 30, 2013 – African-American and Puerto Rican women who have low levels of vitamin D during pregnancy are more likely to go into labor early and give birth to preterm babies, research led by the University of Pittsburgh Graduate School of Public Health reveals.

The study, the largest to date to look at the association between vitamin D and preterm birth, is now available online in the American Journal of Epidemiology.

“Vitamin D is unique in that while we get it from our diets, our primary source is our body making it from sunlight,” said lead author Lisa Bodnar, Ph.D., M.P.H., R.D., associate professor in Pitt Public Health’s Department of Epidemiology. “Previous studies using conservative definitions for vitamin D deficiency have found that nearly half of black women and about 5 percent of white women in the United States have vitamin D concentrations that are too low.”

Among non-white mothers, the incidence of spontaneous, preterm birth – naturally going into labor two or more weeks before the 37 weeks of pregnancy considered full-term – decreased by as much as 30 percent as vitamin D levels in the blood increased.

Dr. Bodnar and her co-authors, whose work was funded by the National Institutes of Health, did not find a similar relationship between maternal vitamin D levels and preterm birth in white women.

“We were concerned that finding this association only in non-white women meant that other factors we did not measure accounted for the link between low vitamin D levels and spontaneous preterm birth in black and Puerto Rican mothers,” said Dr. Bodnar. She and her co-authors used methods to account for the expected influence of discrimination and socioeconomic position, as well as fish intake and physical activity. “Even after applying these methods, vitamin D deficiency remained associated with spontaneous preterm birth.”

“Preterm birth is the most important problem in modern obstetrics,” said senior author Hyagriv N. Simhan, M.D., M.S., chief of the division of maternal-fetal medicine and medical director of obstetrical services at Magee-Womens Hospital of UPMC. “In 2010, over 1 million infants born preterm at less than 37 weeks gestation died worldwide. Preterm infants who survive are at risk of chronic lung disease, deafness, blindness or other visual impairment, and learning and cognitive disability.”

A novel part of the study was the availability of information from placental examinations. The researchers found that vitamin D deficiency was most strongly related to preterm births with damage to the placenta caused by inflammation.

“This finding may give us insight into the biology connecting low vitamin D and preterm birth,” Dr. Simhan said. “It holds great promise and will motivate significant preterm birth research.”

The researchers used a sample of over 700 cases of preterm birth and 2,600 full-term births collected by the Collaborative Perinatal Project, which was conducted in 12 U.S. medical centers from 1959 to 1965. The blood samples collected by the project were well-preserved and able to be tested for vitamin D levels 40 years later.

“It is critical to repeat this study in a modern sample,” said Dr. Bodnar, noting that pregnant women today smoke less, have less sun-exposure and receive more vitamin D in their foods than the mid-century cohort. “Further, it is especially important to understand how vitamin D influences preterm birth among black mothers. Vitamin D supplementation could be an easy way to reduce the high rates of preterm birth in this group.”

Co-authors on this research include Alison D. Gernand, Ph.D., Janet M. Catov, Ph.D., and W. Tony Parks, M.D., all of the University of Pittsburgh; Mark A. Klebanoff, M.D., of the Ohio State University; and Robert W. Platt, Ph.D., of McGill University.

This work was supported by NIH grant HD 056999.

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