Use Art-assist and Neupogen to Treat Chronic Limb Ischemia
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|ClinicalTrials.gov Identifier: NCT02408991|
Recruitment Status : Withdrawn (PI left University)
First Posted : April 6, 2015
Last Update Posted : April 8, 2016
The purpose of this study is to measure the concentration of cells and proteins in the patient's blood during administration of Nuopogen (Filgrastim), a medication that is FDA approved for stem cell mobilization, in combination with a programmed pneumatic compression device (PPCD) (Art-Assist Device). The Art-Assist Device is an FDA approved device that promotes blood flow in the patient's legs. A patient will be prescribed this device and this drug to help improve the poor circulation in his/her leg. The use of Nuopogen along with the Art-Assist Device has not been approved by the FDA and is considered experimental.
This study is not designed to find out how well the Art-Assist Device works, nor how well the drug works in mobilizing stem cells. Instead, it is a study of how well cells lining blood vessels in calf respond to increases in shear stress, and how well the increase in the population of certain cells in the blood stream effect how the new blood vessels will form. It is important for clinical reasons, and for the purposes of this study, that the patient uses the Art-Assist Device as prescribed on a daily basis as discussed with the patient's doctor
|Condition or disease||Intervention/treatment||Phase|
|Lower Limb Ischemia||Drug: Neupogen Device: Art-Assist Device||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proteomics and Stem Cell Therapy as a New Vascularization Strategy|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: AA and Neopogen
Patient undergoes treatment with Art-assist device and Neupogen
Neupogen is given as an injection in your skin every three days for a total of 5 doses.
Other Name: Filgrastim
Device: Art-Assist Device
The programmed pneumatic compression device (PPCD) is to be worn for a minimum of three hours daily while patient is sitting down
Other Name: The programmed pneumatic compression device (PPCD)
- Measuring the pharmacologic increase in of CD31+ (mature endothelial cell) [ Time Frame: 4 months ]Using the FACSaria sorter. Following clot formation (30 min) each tube will be centrifuged for 15 min at 1000g and the separated serum will be stored at -20° C. Protein will be measured using Enzyme-linked immunosorbent assays (ELISA).
- Measureing the pharmacologic increase in CD34+(progenitor cell), [ Time Frame: 4 months ]Using the FACSaria sorter. Following clot formation (30 min) each tube will be centrifuged for 15 min at 1000g and the separated serum will be stored at -20° C . Protein will be measured using Enzyme-linked immunosorbent assays (ELISA).
- Measureing the pharmacologic increase in VEGFR2+ (endothelial progenitor cell) [ Time Frame: 4 months ]Using the FACSaria sorter. Following clot formation (30 min) each tube will be centrifuged for 15 min at 1000g and the separated serum will be stored at -20° C . Protein will be measured using Enzyme-linked immunosorbent assays (ELISA).
- Pharmacologix measurement of nitrite [ Time Frame: 4 months ]Nitrite will be measured with a quantitative fluorometric assay based on the reaction of nitrite with 2,3- diaminonaphthalene under acidic conditions to form the highly fluorescent 1-(H)-naphthotriazole: 80 l of freshly prepared DAN reagent (25 M in 0.62 M HCl) is added to each 0.8 ml medium sample and mixed immediately. After 10-min incubation at 20°C, the reaction is terminated with 40 l 2.8N NaOH. Formation of 1-(H)-naphthotriazole is measured with a spectrofluorophotometer (model RF-5000; Shimadzu, Kyoto, Japan) with excitation at 380 nm and emission at 405 nm. Nitrite concentrations are determined relative to a standard curve.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408991
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Darwin Eton, MD||Univ of Chicago|