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Bettina Mittendorfer

Bettina Mittendorfer, PhD, NextGen Precision Health Endowed Professor of Medicine and senior associate dean for research in the School of Medicine, says phase I clinical trials are a critical component of the “bridge” between discoveries and making treatments available to patients. She uses the CTSU in her research to evaluate the mechanisms responsible for increased heart disease risk in people with Type I diabetes and those with obesity. Photos by Ben Stewart

Each year, University of Missouri scientists run hundreds of clinical research studies to test potential treatments and therapies that could improve human and animal health.

Many studies with human subjects are conducted in partnership with Mizzous Clinical Translational Science Unit (CTSU). The CTSU, which has 10,000 square feet of space in the NextGen Precision Health building and 5,000 square feet in University Hospital, offers a wide array of services and capabilities for researchers, including the capacity to hold phase I, or early, clinical trials.

Although Missouri’s largest metropolitan areas, St. Louis and Kansas City, also have units that can hold phase I trials, Mizzou offers something they can’t.

The CTSU’s location in central/rural Missouri provides investigators with access to populations that are typically underrepresented in clinical research,  says Bettina Mittendorfer, senior associate dean for research at the School of Medicine and director of the NextGen Precision Health CTSU. This helps ensure people from rural America are represented in important discoveries and decisions that affect their health and health care.

Mittendorfer says theres almost no limit when it comes to the type and variety of studies that can be conducted in the CTSU. Learn more in the below Q&A.
 

What kind of studies can be conducted in the CTSU? 

Research with children, adolescents and adult participants can be conducted in the CTSU, including:

  • Phase 0-IV pharmaceutical and medical device clinical trials.
  • Complex and sophisticated physiological assessments, such as body composition and bone imaging, blood flow regulation, insulin sensitivity and beta-cell function.
  • Cognitive testing.
  • Neuromuscular and physical function testing, such as muscle activation, strength and endurance.
  • Exercise training studies.
  • Diet evaluation and nutrition intervention studies.
     
Two women demonstrate a blood pressure cuff in the CTSU.

Currently, the CTSU provides support for about 3,000 research participant study visits per year. Staff hope to grow the number of studies in the unit’s research portfolio in the future.
 

Why should Mizzou researchers consider using CTSU services?

The CTSU is a “one-stop shop” for clinical and translational research support. Collaborating with the Clinical Research and Trial Support Office and the Cancer Clinical Trials Office makes it possible to support investigators from study startup to closeout.
 

  • The CTSU is equipped with routine and specialized equipment that is frequently used in clinical research and is staffed with highly skilled research nurses, advanced care practitioners, clinical research coordinators, research assistants, and a research lab technician who can help investigators conduct high-quality research protocols in an efficient, cost-effective, safe and compliant manner. 
     

  • The availability of licensed health care professionals who work in collaboration with and under the supervision of the CTSU medical director makes it possible for non-MD/PhD investigators to conduct sophisticated clinical research. 
     

  • The CTSU can support both outpatient and inpatient research study visits (including overnight stays). Additionally, CTSU staff provide off-site support as needed. 
     

  • Another plus is that the CTSU partners with and provides easy access to the Clinical Translational Imaging Unit, also housed in the NextGen building, and facilitates research studies that rely on sophisticated MRI, CT scan and PET scan imaging modalities. 
     

Kris Kelly, right, works with patient in CTSU study

Kris Kelly, assistant research professor of physical medicine and rehabilitation, conducts a whole-body DEXA scan of a participant in a muscle aging study that evaluated a new biomarker for assessing sarcopenia, a condition characterized by the progressive loss of muscle mass, strength and function.


How are researchers using the CTSU?
  • W. David Arnold, MD, NextGen Precision Health Endowed Professor of physical medicine and rehabilitation, neurology and medical pharmacology and physiology and executive director of the NextGen Precision Health initiative, uses the CTSU to evaluate novel treatments to improve physical function in patients with degenerative muscle diseases, such as Charcot-Marie-Tooth (CMT) disease and amyotrophic lateral sclerosis (ALS).
  • Kris Kelly, assistant research professor of physical medicine and rehabilitation, uses the CTSU to evaluate the effects of whole-body electrical muscle stimulation exercise on adults with myasthenia gravis (MG) and older adults.
  • Jacqueline Limberg, PhD, associate professor of nutrition and exercise physiology, uses the CTSU to study hypertension and heart disease in women.
  • Camila Manrique-Acevedo, MD, Thomas W. Burns, MD, Distinguished Professor in Diabetes Research, uses the CTSU to evaluate interventions to prevent kidney and heart disease in people with type 2 diabetes.
  • Xiu-Feng (Henry) Wan, PhD, Curators Distinguished Professor of molecular microbiology and immunology, uses the CTSU to identify biomarkers of the immune response to influenza infection to determine who might be at risk for developing severe disease.
     
What are your goals for CTSU?

The overall goal is to utilize the CTSU to its maximal capacity by increasing the number of users and growing the breadth of the research portfolio the CTSU supports. A very specific goal is to build out capacity to conduct theranostic clinical trials, which would use radiopharmaceutical products that can be produced at the MU Research Reactor for the diagnosis and treatment of diseases, especially cancer.
 

How should researchers request services?

The first step is for investigators to send an email to ClinicalResearch@health.missouri.edu.
 

Anything else we should know?

A huge thank you goes to the research participants. The CTSU and our investigators could not do this important work without the willingness of people to participate in the research study protocols.