Research Update

June 2017

Clinical Trial to Help Children with Systemic Juvenile Idiopathic Arthritis

Jace (pictured above with research nurse Kathy Hummel) was the one to make the decision to participate in the study. He wanted to change or save someone’s life, keeping them from repeated hospital visits and pain.

This summer, 9-year-old Jace will be out playing and running with his friends like many children. However, four years ago, the hot summer months would have been different. Jace was having difficulty turning his head. Testing ruled out meningitis. Soon, he was having pain in a knee and next in an ankle. Standing and walking became hard and was impossible at times. A series of trips to doctors and stays at hospitals left misdiagnoses and questions for his family as Jace would have fevers reaching 105°F every few hours. After months, it was determined Jace had juvenile idiopathic arthritis (JIA).

JIA is a type of chronic arthritis involving long-term joint inflammation. With JIA, the immune system becomes active for unknown reasons, attacking healthy cells and tissues. JIA symptoms begin before children are 16 years old and must last for at least six weeks.

Jace’s pediatrician in eastern Oklahoma could not locate a pediatric rheumatologist nearby for them. The family first went to a children’s hospital in Dallas for treatment including physical therapy. Diagnosed there with systemic juvenile idiopathic arthritis (sJIA), Jace transferred to Arkansas Children’s Hospital.

Of all children with JIA, 10% and 15% of them have sJIA. With sJIA, inflamed joints become red, swollen, and painful or hot to the touch, and widespread inflammation of the body occurs resulting in fever and rash. Fevers may be prolonged and repeating, usually occurring once or twice per day. When a fever is at its worst, a child may have a pink skin rash as well as feel tired and achy or have widespread aches and pains. Inflammation and swelling accompanying sJIA may affect internal organs such as the heart, liver, spleen, and lymph nodes.

ACH has the only pediatric rheumatology clinic in the state. Dr. Jason Dare, one of only two rheumatologists at ACH, has conducted clinical research at ACH for almost 10 years. Most of his research involves FDA-approved medications for adults with rheumatoid arthritis that are being studied for treatment for children with JIA.

At the pediatric rheumatology clinic, Certified Clinical Research Coordinator, Kathy Hummel, contacted the family about an industry-sponsored trial for a biologic, immunosuppressive drug to treat sJIA. After the family spoke with Mrs. Hummel, Jace was the one to make the decision to participate in the study. He wanted to change or save someone’s life, keeping them from repeated hospital visits and pain. His mom Cindy, rightfully calls him “a truly amazing kid.”

Initially, Jace received an intravenous infusion, a process taking 3 to 4 hours and occurring every 2 weeks in Day Medicine. Now, Jace receives an injection weekly at home and has scheduled appointments every 2 months at the PCRU for blood draws and physicals. Jace and Cindy do not mind the 4-hour trips to ACH. “Trips to the PCRU are like coming to visit family rather than going to the doctor’s office,” Cindy said. As far as the PCRU visits, Jace enjoys them except for the shot. However, Jace now faces the injections and blood draws bravely with no hesitation. Cindy noted that Jace holds her hand when she is donating blood.

“I enjoy participating in clinical trials because it gives our patients access to the latest treatments for their disease while paving the way to make it safer and easier for future patients to get the best treatment available,” noted Dr. Dare, “The success of our clinical trial program depends on patients like Jace!”

Dr. Greg Kearns Receives Ross and Mary Whipple Family Distinguished Research Scientist Endowed Chair

 
 

Ms. Marcy Doderer, President and CEO of Arkansas Children’s presents a special medallion to Dr. Greg Kearns at the investiture ceremony. 

On June 14, Dr. Greg Kearns, PharmD, PhD, FCP, FAAP, was invested as the recipient and steward of the Ross and Mary Whipple Family Distinguished Research Scientist Endowed Chair. The Whipple family established the chair in 2015 in honor of the career of Richard F. Jacobs. The gift supports innovative research in more than ten pediatric subspecialties at Arkansas Children’s research Institute (ACRI). This endowed chair will provide funding for recruitment and support of innovative research in the laboratory and throughout the state.

Dr. Kearns serves as the Chief Research Officer for Arkansas Children’s and President of ACRI and is a professor of Pediatrics at UAMS. After graduating from St. Louis College of Pharmacy in 1977, Dr. Kearns received a Doctor of Pharmacy degree from the University of Cincinnati. In 2002, he graduated from Erasmus University and was awarded the Doctor of Philosophy degree in Clinical Pharmacology.

Dr. Kearns is serving his third term as a delegate on the World Health Organization’s Expert Committee on the Evaluation and Selection of Essential Medicines. He was one of the co-authors on the first Essential Medicines for Children list published by WHO a decade ago. He has also served on the Clinical Pharmacology Advisory Committee for the Food and Drug Administration. With dozens of academic awards and distinctions, Dr. Kearns and his work in pediatric clinical pharmacology are celebrated worldwide.

As the inaugural recipient of the Ross and Mary Whipple Family Distinguished Research Scientist Endowed Chair, Dr. Kearns will support his research exploring the intersection of obesity and genomics on taste perception. He will also designate endowed funds to support cutting-edge research at ACRI.

During the investiture ceremony in Brandon Auditorium, collegial remarks were provided by Dr. Valentina Shakhnovich and Dr. J. Steven Leeder, both of Children’s Mercy in Kansas City, and Dr. Laura James of UAMS. Dr. Kearns was presented with a special medallion and chair by Dr. Pope Mosely, Dean of the UAMS College of Medicine; Ms. Dee Ann English, Chair of the ACRI Board of Directors; and Ms. Marcy Doderer, President and CEO of Arkansas Children’s. A reception was held in the Arkansas Children’s Mission Center.

The Arkansas Children’s Foundation organized and planned the ceremony and reception. Foundation staff maintain Arkansas Children’s relationship with the donors and steward the funds.

Mr. Whipple served on the ACRI Board of Directors from 2007 to 2016. During part of his term on ACRI’s board, he served as Chair of the Finance Committee. Dr. Jacobs is a former President of ACRI (2004-2015) and Chair of the Department of Pediatrics (2007-2017). Dr. Jacobs will retire from UAMS at the end of June.

Dr. Laura James receives Fiser Research Achievement Award

 
 
 
 
 
 

 

Dr. Laura James (left) receives the Fiser Research Achievement Award from Arkansas Children's President & CEO Marcy Doderer.

At the 2017 Ruth Olive Beall Service Awards banquet, Dr. Laura James received the Dr. Robert H. Fiser, Jr., Research Achievement Award. The award was created to honor the accomplishments of an at Arkansas Children’s Research Institute research scientist who has distinguished himself or herself through extraordinary scientific research that will have lasting impact on the health, development, and well-being of children and their families.

A consummate academic pediatrician who excels as a clinician, educator, researcher, and advocate, Dr. James has made extraordinary contributions in scientific research that have impacted children and pediatric healthcare and will continue to have a lasting and global impact. She has distinguished herself at ACRI, UAMS, and nationally and internationally through her driving commitment to excellence and her innovative scientific investigation. She has been a steadfast advocate for children's health and pediatric research both at UAMS and ACH/ACRI and through her work at the NIH and within numerous organization within the state and nationally.

Dr. James’ accomplishments are far reaching and have also served as a platform for career development and mentoring for many research faculty, resident trainees, and graduate/undergraduate students at ACRI, UAMS, and beyond. Her research over the last two decades has focused on the impact of acetaminophen overdose on liver toxicity in pediatrics. This work that has not only advanced scientific understanding of disease mechanisms, but also has been translated to applied diagnostics with development of a rapid testing method for acetaminophen toxicity through innovative biotechnology.

Dr. James has previously served as the Chief of Pediatric Pharmacology/Toxicology at ACH and as the Director of the NIH-funded Pediatric Pharmacology Research Unit at ACRI. Since 2005, she has been an invited NIH Study Section member. In addition, Dr. James serves as Co-PI for the newly, NIH-funded Arkansas Center for Advancing Pediatric Therapeutics at ACRI. She is the Director of the Translational Research Institute, Associate Vice Chancellor for Clinical and Transformational Research and Professor in the Department of Pediatrics.

Most recently, Dr. James received the 2017 Translational Impact Award from the Society of Toxicology. According to the Society of Toxicology, the Translational Impact Award is presented to a scientist whose recent (last 10 years) outstanding clinical, environmental health, or translational research has improved human and/or public health in an area of toxicological concern.

Dr. James has contributed across all facets of scientific investigation at ACRI and UAMS, continually serving as an innovative researcher, an inspiring mentor, and a visionary leader whose work and leadership will continue to have a durable and lasting impact. Nominator Dr. Stacie Jones said, “I have no doubt that Dr. Fiser would be enormously proud of Dr. James and her continued contributions in pediatric healthcare and research.”

Dr. James received her Doctor of Medicine from the University of South Carolina in 1989. She completed her pediatric residency at Arkansas Children’s Hospital and UAMS, then moved in 1992 to Birmingham, where she completed her pediatric emergency medicine fellowship at the University of Alabama and The Children’s Hospital of Alabama. In 1992, she returned to Arkansas for her pediatric clinical pharmacology/toxicology fellowship at UAMS and ACH.

The award is named for Dr. Robert Fiser, Jr., Chairman of the Department of Pediatrics from 1975 to 1994. At age 32, he became the youngest pediatric department chairman in the US. Under his leadership the Department of Pediatrics grew from a five-member faculty to a faculty of more than 100 full-time physicians. Dr. Fiser strategically used the relationship between the department and ACH to position our state as a leader in superior health care. In his professional career, Dr. Fiser was a successful researcher in the area of endocrinology and continued that work while being the Chair of the Department of Pediatrics. His commitment to research and the academic missions of the Department of Pediatrics was outstanding and laid the foundation for many of the research programs in place today.

ACRI and UAMS Department of Pediatrics Achieve Top 6 Ranking Among Pediatric Research Organizations

Research awards from the National Institutes of Health (NIH) to Arkansas Children’s Research Institute (ACRI) and the UAMS Department of Pediatrics place this pair of the foremost Arkansas institutions committed to children’s health and well-being sixth highest among children’s hospitals and their university-affiliated department of pediatrics nationally. The rankings are tabulated annually and include data from the 220 Children's Hospital Association member hospitals. The combined strengths of ACRI and the UAMS Department of Pediatrics and the persistent dedication of their physicians and scientists have resulted in a record amount of NIH funding for 2016.

"This recognition is a testimonial to the continued, growing success of the entire team of researchers at ACRI and in the Department of Pediatrics. The increased funding from NIH reflects not only upon the quality of the science and discoveries produced at Arkansas Children's, but also to the abilities of our faculty to serve as leaders in pediatric research in the nation,” said Greg Kearns, PharmD, PhD, Chief Research Officer for Arkansas Children’s and President of ACRarch Institute.

Recent major NIH awards include one for oversight of a 17-site pediatric clinical trial network that will provide medically underserved and rural children access to clinical studies of environmental influences on early development and another for the creation of a multidisciplinary center to strengthen ACRI’s pediatric obesity research capacity and create mentoring pathways for emerging scientists focusing on pediatric obesity. ACRI has most recently received funding from NIH for a center to conduct clinical trials, observational studies, and basic research to treat and prevent food allergy-associated anaphylaxis and food allergy-associated eosinophilic gastrointestinal disease.

This standing of ACRI and the UAMS Department of Pediatrics among children’s hospitals and their university partners marks the first appearance of the pairing in the top 10 nationally. As NIH is the primary federal agency providing support for pediatric research, NIH funding is considered the most prestigious recognition of the importance and impact of the investigation proposed by a researcher.

“The listings of these new rankings are something to celebrate. It is a win for the kids and families since research is where ‘miracles begin.’ It is also a testimonial to the hard work, dedication, and commitment of our research community at ACRI and UAMS and in the Department of Pediatrics. The future is very bright, and the incredible work will continue. It is an exciting time for research with our team,” said Richard Jacobs, MD, Chairman, Department of Pediatrics, UAMS.

Dr. Sarah Blossom Invited as Technical Advisor to Camp Lejeune Community Assistance Panel

In March, Dr. Sarah Blossom accepted an invitation to serve as a Technical Advisor to the Camp Lejeune Community Assistance Panel (CAP) established through the CDC’s Agency for Toxic Substances and Disease Registry (ATSDR). The Marine Corps Base at Camp Lejeune was contaminated with high levels of trichloroethylene (TCE) and other environmental toxicants in the drinking water supply for over 30 years. A limited number of studies have been conducted that examined the health problems related to this exposure including birth defects and other pregnancy-related complications and cancer. However, there have been no studies yet to date that have examined immune effects.

The ASTDR is interested in immune system issues among the Camp Lejeune community. Dr. Blossom’s knowledge of immunotoxicology and her research into TCE are of special interest to the CAP. She was an invited speaker to the panel last year. Her service will include three in-person CAP meetings annually and monthly telephone conferences.

Dr. Blossom has studied the role of environmental toxicants, particularly TCE, in the development of autoimmune disease at ACRI since 2003 with the Arkansas Center for Environmental Exposure Research, created by Dr. Kathleen Gilbert with funds from the Arkansas Biosciences Institute, the major research component of the Tobacco Settlement Proceeds Act of 2000. With support from an NIH R01 research grant, Dr. Gilbert and Dr. Blossom are presently testing the suggestion that the developing immune system is even more sensitive than the adult immune system to chemical toxicity by using their mouse model of TCE exposure. In addition, they are testing whether early life exposure to TCE causes “heritable” long-term alterations in CD4+ T cells that predispose the individual to developing autoimmunity at some point in their in life. If their hypothesis is confirmed, it would support the concept that early-life exposure to chemicals at levels previously thought safe can trigger autoimmune disease in adulthood or even childhood. An NIH research supplement is examining differences in susceptibility to toxicant-induced autoimmunity in male and female mice.

Dr. Blossom currently holds a non-mentored K02 NIH Career Development Award to examine how the immune system affects brain and behavior in the TCE mouse model with developmental exposure. She is using the male mice from the R01-funded study to examine the role of T cells in brain oxidative stress and behavioral alterations. Her team is observing the males in this study for neurotoxicity that may be related to certain neurological disorders, as they are more prevalent in males. As the award includes a training component, Dr. Blossom is expanding her research to clinical studies in humans with the long-term goal of linking maternal inflammation to neurological disorders to clinical studies in humans. Towards this goal, Dr. Blossom is the recipient of three consecutive UAMS Sturgis Diabetes Research Grants to conduct research linking maternal inflammation in diabetic pregnancy with an adverse maternal/infant outcome in collaboration with physicians in the UAMS Department of Obstetrics and Gynecology. This clinical work is a component of the CDC-funded BD-STEPS (Dr. Wendy Nembhard, PI). 

Researcher Spotlight:  V. Laxmi Yeruva, PhD 

Dr. Yeruva is an Assistant Professor of Pediatrics in the section of Developmental Nutrition.

How did you become involved in pediatric research?

My career has been in the Chlamydia field for the last several years. We have shown that Chlamydia persists in the gastrointestinal tract, and this expertise in microbiology and immunology of the gut brought me to the ACNC team by Dr. Tom Badger in 2013. My current goal as an ACNC faculty member is to understand neonatal diet’s impact on gut immune system development and the microbiota’s role in gut immune system development.

What types of sponsors support your studies?

We are supported by USDA-ARS.

What is your area of study?

My research focuses on health-oriented basic and translational studies of immunity. A key area of research at ACNC is centered on understanding whether breast-fed children have any advantage in terms of gut development, immune function and also programming of growth and body composition. It has been suggested that breast-fed infants have advanced immune system development compared to formula-fed infants, and dietary factors in breastmilk and formulas can alter gut microbiota composition. However, does the microbiome alone shape gut development and subsequent immune function in infants? Do breast-fed children have better immune responses to infections? In order to understand and address these questions we utilize a piglet model of infant formula or breast milk feeding.

How is your research program innovative?

Our research is important because it (1) contributes to the scientific evidence base related to breastfeeding and (2) is helping understand the fundamental biology of the infant intestinal and immune development and how gut bacteria influence these processes.

How has your work led to (or will lead to) changes in pediatric care?

Our efforts can lead to improved infant formula by adding components that are unique to breast milk or that modify the gut microbiota to help boost the immune system in infants. We also know that our results can help increase the scientific evidence base surrounding breastfeeding recommendations.

Who do you collaborate with and what are the benefits of these collaborations?

We collaborate with the ACNC Informatics Team (Drs. Piccolo, Chintapalli and Bhattacharyya), Dr. Adams, Dr. Shankar and Dr. Mercer. ACNC projects benefit from interdisciplinary approach of conducting research, bringing several different experts to the table, which helps in the success of the projects.

Recent ACRI Researcher Publications

  • Morse AM, Aitken ME, Mullins SH, Miller BK, Pomtree MM, Ulloa EM, Montgomery JS, Saylors ME. Child Seat Belt Guidelines: Examining the 4'9" Rule as the Standard (Examining the 4'9" Rule as the Standard). J Trauma Acute Care Surg. 2017 Apr 27. 
  • Wankhade UD, Zhong Y, Kang P, Alfaro M, Chintapalli SV, Thakali KM, Shankar K. Enhanced offspring predisposition to steatohepatitis with maternal high-fat diet is associated with epigenetic and microbiome alterations. PLoS One. 2017 Apr 17;12(4):e0175675. doi: 10.1371/journal.pone.0175675. eCollection 2017.
  • Kuo DZ, Lyle RE, Casey PH, Stille CJ. Care System Redesign for Preterm Children After Discharge From the NICU. Pediatrics. 2017 Mar 1. pii: e20162969.

Public Announcement: 2017 Certificate of Achievement from Quintiles

As part of the QuintilesIMS premiere network of high performing, high quality research sites, Arkansas Children’s Hospital Research Institute was awarded a 2017 Certificate of Achievement, recognizing our commitment to the highest standards of clinical research on projects managed by QuintilesIMS in 2016.  Our partnership with QuintilesIMS promotes collaboration to support awareness of, and access to, clinical research trials for the patients we serve. Together we are changing the way clinical trials are executed, and working together to accelerate new treatments to patients around the globe.  

Recent Clinical Trials Activity

Clinical Trials

Agency

Project Description

Project Period

Total Cost

Sharp, Gregory

  Zogenix

Dravet Syndrome

5/1/17 -

$159,708.00

Hutchison, Michele

  Takeda

T2DM

5/1/17 -

$43,449.90

Crary, Shelley

  Pfizer

Rivipansel

5/1/17 -

$59,153.83

Hobart-Porter, Nick

  Kamada, Ltd.

KamRAB

5/1/17 -

$100,242.30

Bielamowicz, Kevin

  MSKCC

Neratinib

5/1/17 -

$83,250.00

Vijayan, Vini

  Merck

Tedizolid Phosphate

5/1/17 -

$65,156.00

Sharp, Gregory

  GW Pharma

Dravet Syndrome

6/1/17 -

$103,300.00

Recent Grant Activity

Awards
       
PI Agency Project Title Project Period Total Funding

Yuri Zarate

PCORI

Patient and Stakeholder Alliance for SATB2-Associated Syndrome

6/2017-5/2019

$249,217.00

Submissions
       
PI Agency Project Title Project Period Total Funding

Amy Scurlock

Food Allergy Research & Education (FARE)

FARE Clinical Network

7/2017-6/2018

$90,000.00

Jin-Ran Chen

NIH

Hippuric acid epigenetically suppress bone resorption in mince

4/2018-3/2023

$2,603,296.00

Sarah Blossom

NIH sub East Carolina University

Defining the metabolite profile and immunomodulatory effects following aqueous film forming foam (AFFF) exposure in rodent models and humans

4/2018-3/2021

$30,722.00

ACRI Postdoctoral Fellowship Grant Proposal Submissions
   
PI Sponsor Project Title Project Period Total Funding

Jennifer Rumpel

ACRI

Early Diagnosis of Acute Kidney Injury using Urinary Biomarkers and Renal Oximetry in Neonates with Hypoxic Ischemic Encephalopathy

7/2017-6/2019

$15,000.00

Joanna Mack

ACRI

Analyzing coagulation dynamics in vascular malformations with thromboelastography

7/2017-6/2019

$15,000.00

Patrick Bonasso

ACRI

Direct Peritoneal Resuscitation in Gastroschisis

7/2017-6/2018

$9,656.00

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