{"id":606,"date":"2015-09-25T15:17:29","date_gmt":"2015-09-25T19:17:29","guid":{"rendered":"https:\/\/med.sites.unc.edu\/cfpulmcenter\/spirovation\/clinical-capabilities\/"},"modified":"2018-03-23T11:51:04","modified_gmt":"2018-03-23T15:51:04","slug":"clinical-capabilities","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/marsicolunginstitute\/spirovation\/clinical-capabilities\/","title":{"rendered":"Clinical Capabilities"},"content":{"rendered":"

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We work with our partners to identify, design and execute joint research activities more efficiently and more strategically so that milestones are met as quickly and efficiently as possible.<\/p>\n

Novel Airway Surface Pharmacokinetics Techniques<\/h2>\n
These techniques include extensive experience in bronchoscopy of subjects post-drug delivery and direct (filter paper) and directed lavage techniques for making pharmacokinetic measurements of lung\/airway deposition. Also, exhaled breath condensate (EBC) can be analyzed with high sensitivity by mass spectroscopy offering the ability to measure the drug and metabolite concentration in airway surface liquid.<\/span><\/div>\n

Measures of the Pulmonary Microbiome<\/h2>\n
ºÚÁÏÍø has developed the capacity to measure the respiratory microbiome with 16S-454 pyrosequencing and Illumina MiSeq technologies. This technique has already been applied to studies of acute exacerbations in CF and COPD and measurement of antibiotic effects.<\/div>\n
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Novel Biomarkers for Pulmonary Drug Development<\/h2>\n
Novel biomarkers for measuring the pharmacodynamic and therapeutic effects of inhaled therapeutic agents in sputum. Measures of absolute mucin concentrations, mucin\/mucus osmotic pressure\/modulus, and measures of mucus adhesion in induced or spontaneously expectorated sputum. <\/span>The Sputum Core measures cell counts, cytokines, and growth factors in sputum and BAL.<\/span><\/div>\n<\/div>\n
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Center for Environmental Medicine, Asthma & Lung Biology<\/h2>\n

The CEMALB has great emphasis on translational studies of lung disease and biology.<\/p>\n

\u2013Asthma<\/div>\n
\u2013Allergy<\/div>\n
\u2013COPD<\/div>\n
\u2013Airway infection<\/div>\n
\u2013Systemic effects of inhaled agents (primarily CV)<\/div>\n
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Significant Clinical Research Infrastructure:<\/p>\n

\u2022In vitro primary epithelial cell models<\/div>\n
\u2022Clinical Research (study coordination, scintigraphy, exercise challenge, bronchoscopy)<\/div>\n

Capabilities<\/h3>\n
\u2022Environmental Challenge<\/div>\n
\u2013Ozone<\/div>\n
\u2013PM (CAPS, Woodsmoke)<\/div>\n
\u2013Other gases (NO2)<\/div>\n
\u2013Allergen, Virus<\/div>\n
\u2013IND for allergen and LPS challenge, approvals for ozone<\/div>\n
\n
CEMALB and EPA investigators have developed phase I and IIa programs focused on potential interventions to mitigate the effect of pollutants on airway inflammation<\/div>\n
Studies of genetic and epigenetic regulators of pollutant response, and chemoprevention and pharmacologic intervention are established.<\/div>\n<\/div>\n<\/div>\n

Environmental Challenge Studies and Exposure<\/h2>\n

The Center for Environmental Medicine has exposure chambers that allow for both short-term and long term human exposure studies.<\/p>\n

Approved challenge studies include:<\/p>\n

\u2022House Dust Mite<\/div>\n
\u2022Endotoxin<\/div>\n
\u2022Allergen<\/div>\n
\u2022Ozone<\/div>\n
\u2022Exercise<\/div>\n

CEMALB: Sputum Slide Reading, Biomarker and Biospecimen Core<\/h2>\n

The Core is a major resource for sample acquisition, processing, allocation, analysis, storage, tracking and security. The core serves as a central reading lab for sputum slides.<\/p>\n

Biomarker Analysis in sputum\/BAL\/nasal lavage<\/h3>\n
\u2022Total and Differential Leukocytes Counts<\/div>\n
\u2022Cell viability<\/div>\n
\u2022Proteomics on fluid phase components<\/div>\n
\u2022Flow cytometric markers of cell function (phagocytosis, intracellular oxidative burst, cell surface marker expression)<\/div>\n
\u2022Genomics: gene array; genotyping<\/div>\n
\u2022% solids content<\/div>\n
\u2022Cell isolation\/purification<\/div>\n
\u2022Ex vivo stimulation assays<\/div>\n
\u2022Single cell isolation and mRNA analysis using Isoraft technology<\/div>\n
<\/div>\n

Biospecimen\/Biorepository<\/h3>\n
\n
\u2022Banked human samples that include sputum supernatants, sputum cell pellets in Trizol, nasal lavage, EBC, serum, blood cell pellets in Trizol<\/div>\n
\u2022Biorepository samples from the following subject cohorts at baseline, pre and post inhalation challenge (LPS, Ozone, virus, allergen, methacholine, hypertonic saline)<\/div>\n
\u2022Healthy controls \u2013 Asthmatics \u2013 Allergics\/atopics \u2013 Smokers \u2013 COPD \u2013 CF \u2013 eCig users, Hookah users<\/div>\n
<\/div>\n

Phenotype Database<\/h3>\n
\n
\u2022Sputum endpoints on healthy and diseased subjects<\/div>\n
\u2022Sputum producing capability (producers vs non-producers)<\/div>\n
\u2022Responder vs non-responder status to inhalation challenges (ozone, lps)<\/div>\n
\u2022Genotype status for target polymorphisms (GSTM1null)<\/div>\n<\/div>\n<\/div>\n

Mucociliary Clearance & Aerosol Research<\/h2>\n

The mission of the Mucociliary Clearance and Aerosol Research Laboratory is to use inhaled aerosols as a tool for studying lung physiology and; t<\/span>o improve treatment of pulmonary diseases such as cystic fibrosis, asthma, and chronic obstructive lung disease. <\/span><\/p>\n

Areas of Focus<\/h3>\n
\n

Our extensive knowledge and experience in the use of radiolabeled aerosols and gamma scintigraphy allows us to assess clearance of mucus from the airways and the delivery of aerosols to the lung. We provide state-of-the-art clinical, animal, and bench research services for evaluating:<\/p>\n

\u2022The effectiveness of new therapies for improving clearance of secretions from the lung and;<\/div>\n
\u2022The efficiency of drug delivery to the lungs for new aerosol treatment devices.<\/div>\n<\/div>\n

Pulmonary and Critical Care Clinical Research Facility<\/h2>\n

The Division of Pulmonary Medicine at ºÚÁÏÍø cares for patients with a wide range of pulmonary diseases, specializing in the care of lung cancer, sleep disorders, cystic fibrosis, pulmonary hypertension, non-CF bronchiolitis, lung transplant, a1-antitrypsin deficiency, sarcoidosis, pleural diseases and primary ciliary dyskinesia.<\/p>\n

Facilities<\/h3>\n
\u2022~4000 square feet of laboratory space, 4 patient exam rooms and waiting room space dedicated to clinical research<\/div>\n
\u2022Mucociliary Clearance Imaging Lab<\/div>\n
\u2022Specimen Processing\/storage facility<\/div>\n
\u2022Fully equipped Pulmonary Function Labs for spirometry (including multiple portable KoKo spirometers), lung volumes, diffusion capacity, multiple breath washouts, nasal potential difference, sputum induction, ECG and vital signs<\/div>\n
\u2022Phlebotomy lab<\/div>\n

ºÚÁÏÍø Biomedical Research Imaging Center<\/h2>\n

The BRIC contains world-class imaging equipment, including a hybrid MRI\/PET whole body scanner, a 7 Tesla MRI whole body scanner, and a cyclotron \u2013 and is one of only two academic medical institutions in the United States that houses all three pieces of technology at one site.<\/p>\n

Capabilities<\/h3>\n
\u2022Radiochemistry: Contains all equipment needed to support radiopharmaceutical development and production for molecular imaging studies under GMP.<\/div>\n
\u2022PET probes include [18F]FDG, [11C]FMAU, [18F]FMAU, [18F]FHBG, [18F]5-fluorouracil, [15O]H2O, [15O]CO, [15O]CO2, [13N]NH3, and [18F-FB\/64Cu-DOTA]-RGD et al.<\/div>\n
\u2022Cyclotron:<\/div>\n
\u2022GE PETtrace 880 Cyclotron is capable of accelerating both protons and deuterons for maximum flexibility.<\/div>\n
\u2022ABT Biomarker Generator is dedicated to the production of 18F-FDG for clinical studies<\/div>\n
\u2022Small Animal Imaging includes: 9.4T MRI, Optical Systems, PET\/CT, SPECT, Ultrasound and CT Systems.<\/div>\n
\u2022Human Imaging: 3T MRI, PET\/MR, PET\/CT or 7T MRI equipment is available.<\/div>\n
\u2022Hyperpolarized 19 F Lung Imaging<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

We work with our partners to identify, design and execute joint research activities more efficiently and more strategically so that milestones are met as quickly and efficiently as possible. 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