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Use Art-assist and Neupogen to Treat Chronic Limb Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02408991
Recruitment Status : Withdrawn (PI left University)
First Posted : April 6, 2015
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AA and Neopogen
Patient undergoes treatment with Art-assist device and Neupogen
Drug: 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)




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female between the ages of 40 and 85.
  2. Chronic limb ischemia Fontaine Class III (ischemic forefoot rest pain) and Class IV (non-healing ischemic ulcers, gangrene) with confirmatory non-invasive vascular testing.

Exclusion Criteria:

  1. Acute limb ischemia requiring emergency treatment.
  2. Non-salvageable foot (e.g. extensive gangrene, advanced infection, rigor mortis, knee/hip flexion contracture, post-stroke paralysis, and hemiparesis).
  3. Untreated hypercoagulability disorder, sickle cell anemia, myeloproliferative disorder.
  4. Dialysis, and sustained elevated Creatinine > 4 mg/dl.
  5. Severe dementia; bed-ridden; non-compliance; unlikely to follow-up; unreliable.
  6. Intolerance of PPCD compression
  7. Morbid obesity (Body Mass Index > 34)
  8. Severe venous insufficiency causing venous stasis ulceration and dermatitis.
  9. Uncorrected significant aorto-iliac, common femoral, and profunda femoral arterial disease
  10. Ulceration precluding PPCD placement.
  11. Active cancer.
  12. Allergy to Nuopogen.
  13. Uncorrected symptomatic coronary artery disease
  14. History of lymphoma or leukemia

Information from the National Library of Medicine

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


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Darwin Eton, MD Univ of Chicago
Publications:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02408991    
Other Study ID Numbers: IRB14-0553
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Chicago:
Chronic lower limb ischemia
Art-Assist Device
Neupogen
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs