Environmental Factor

January 2011


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Clinical Research Unit enhances intramural research

By Robin Arnette
January 2011

Darryl Zeldin, M.D., acting director of the Clinical Research Program

Zeldin said that in addition to using the website to recruit study participants, the CRU staff travels to health fairs in different communities to recruit volunteers. (Photo courtesy of Steve McCaw)

Medical Director Stavros Garantziotis, M.D.

Besides being medical director of the CRU, Garantziotis carries out his own clinical studies there, examining the effects of nanotechnology on human health. His work involves exposing human macrophages and bronchial epithelia cells to nanomaterials and comparing the cells from healthy individuals to those with asthma. (Photo courtesy of Steve McCaw)

The NIEHS Clinical Research Unit (CRU)(http://www.niehs.nih.gov/research/clinical/join/durham/index.cfm) allows the public to participate in clinical trials and also provides Institute researchers with opportunities to augment their basic research with human samples. Both endeavors contribute to understanding how environmental exposures potentially influence human disease.

If you are interested in participating in a clinical research trial at the CRU, please visit the Join a Health Study or Clinical Trial (http://www.niehs.nih.gov/research/clinical/join/index.cfm) Web page or contact the NIEHS CRU admissions desk at 919-541-9899.

During the first week of December 2010, the CRU enrolled its 500th study participant and experienced its busiest week to date, with 42 people volunteering to take part in a clinical study. Darryl Zeldin, M.D., acting director of the Clinical Research Program, (http://www.niehs.nih.gov/research/clinical/index.cfm)said that during the first eight months after its grand opening on July 27, 2009, the CRU saw two or three participants a week, but he believed the totals steadily increased because more NIEHS scientists initiated clinical research projects at the facility.

"When the CRU was first envisioned years ago, everyone thought it was going to be a unit that primarily serviced the physicians on staff," Zeldin explained, "but, if you look at the people who are using the unit now, many of them are Ph.D.s. Their CRU work allows them to translate what they've done for many years at the [research] bench to humans."

CRU scientists have varied backgrounds

The CRU currently serves 13 tenured and 7 tenure-track investigators, with the Ph.D.s outnumbering the M.D.s two to one. Zeldin expects the number of Ph.D. researchers to grow, especially since many of the studies have generated a lot of useful data so far.

One of those researchers is Mike Fessler, M.D., head of the Host Defense (http://www.niehs.nih.gov/research/atniehs/labs/lrb/host-def/index.cfm)and Environmental Innate Immunity(http://www.niehs.nih.gov/research/clinical/eii/index.cfm) Groups. His research has used human monocyte-derived macrophages to dissect a novel innate immunity signaling pathway triggered by apolipoprotein A-I. The work has resulted in the first published report based on CRU data and appears in the journal Cell Metabolism (see text box).

Leader of the Chromosome Stability Group Mike Resnick, Ph.D., (http://www.niehs.nih.gov/research/atniehs/labs/lmg/cs/index.cfm)uses blood cells and alveolar macrophages to study the induction of the Toll-like receptor (TLR) genes by p53 and DNA damage. He and two fellow CRU researchers have submitted a paper that is currently under review by a leading peer-reviewed journal. Resnick said that his group started using human cell lines 10 years ago, and that the opening of the CRU came at the perfect time. "Our research led us to consider using clinical samples, just as the CRU was taking shape," he added.

Ron Mason, Ph.D., (http://www.niehs.nih.gov/research/atniehs/labs/ltp/freerad/index.cfm)heads the Free Radical Metabolism Group, and his work with human blood cells has identified sulfite radicals that contribute to oxidative protein damage in asthma and allergic inflammatory disorders. He is preparing a manuscript that he hopes to publish sometime in spring 2011.

NIEHS/NTP Director Linda Birnbaum, Ph.D.,(http://www.niehs.nih.gov/about/od/director/index.cfm) NTP Associate Director John Bucher, Ph.D.(http://www.niehs.nih.gov/research/atniehs/dntp/index.cfm), and Acting Director of the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR)(http://cerhr.niehs.nih.gov/) Kristina Thayer, Ph.D., plan to examine the endocrine disruptor bisphenol A (BPA) after oral exposure.

Birnbaum said, "We are interested in understanding how rapidly BPA is eliminated from the body and whether we can find any BPA present in the blood of subjects after treatment."

The CRU staff makes it all work

CRU-supported researchers interact with Medical Director Stavros Garantziotis, M.D.(http://www.niehs.nih.gov/research/clinical/join/durham/cru-interview.cfm) and his hard-working staff of six - two federal employees, biologists Annette Rice and Jamie Marshburn who process and distribute samples, and four contract personnel, nurse Brenda Yingling, R.N., study manager Neha Mehta, study coordinator Lisa Murphy, and receptionist Nicole Edwards.

According to Garantziotis and Zeldin, the CRU has reached its maximum capacity of 40-45 study participants a week, but, starting in January 2011, they'll add another nurse and study coordinator to accommodate the increased need. "The new staff additions will allow us to step up recruiting efforts and could potentially push us up to 50-100 study participants a week," Zeldin said.

NIEHS/NTP Director Linda Birnbaum, Ph.D.

Birnbaum said that her clinical pharmacokinetic study of BPA is a natural extension of some of the work that she's done in the past. (Photo courtesy of Steve McCaw)

Mike Fessler, M.D.

Fessler wrote the first Institutional Review Board (IRB) protocol allowing for human subjects research at the CRU. The protocol detailed how to collect blood cells from healthy volunteers. He has also been a member of the NIEHS Clinical Advisory Council, an advisory board that reviews clinical research proposals. (Photo courtesy of Steve McCaw)

Mike Resnick, Ph.D.

Resnick said that the CRU was solely responsible for helping him develop a clinical focus for his research. (Photo courtesy of Steve McCaw)

Ron Mason, Ph.D.

Mason's current affiliation with the CRU isn't his first experience with clinical research. Before coming to NIEHS, he performed clinical studies at the Veteran's Administration Medical Center at the University of Minnesota-Minneapolis. (Photo courtesy of Steve McCaw)

Studies based on research in the CRU

  • Smoak KA, Aloor JJ, Madenspacher JH, Merrick BA, Collins JB, Zhu X, Cavigiolio G, Oda MN, Parks JS, Fessler MB.(http://www.ncbi.nlm.nih.gov/pubmed/20519121) Exit NIEHS 2010. Myeloid differentiation primary response protein 88 couples reverse cholesterol transport to inflammation. Cell Metab 11(6):493-502. (impact factor 17.350)
  • Menendez D, Shatz M, Smoak KA, Garantziotis S, Fessler MB, Resnick MA. The Toll-like receptor gene family is integrated into human DNA damage and p53 networks. Accepted with revisions, PLoS Genetics (impact factor 9.532)
  • Ranguelova K, Rice AB, Garantziotis S, Mason RP. Formation of reactive sulfite-derived free radicals by the activation of human neutrophils. An ESR study submitted


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