Lower Limb Ischemia Clinical Trial
Official title:
Proteomics and Stem Cell Therapy as a New Vascularization Strategy
Verified date | April 2016 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Data and Safety Monitoring Board |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 85 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. — View Citation
Bussolino F, Wang JM, Defilippi P, Turrini F, Sanavio F, Edgell CJ, Aglietta M, Arese P, Mantovani A. Granulocyte- and granulocyte-macrophage-colony stimulating factors induce human endothelial cells to migrate and proliferate. Nature. 1989 Feb 2;337(6206):471-3. — View Citation
Bussolino F, Ziche M, Wang JM, Alessi D, Morbidelli L, Cremona O, Bosia A, Marchisio PC, Mantovani A. In vitro and in vivo activation of endothelial cells by colony-stimulating factors. J Clin Invest. 1991 Mar;87(3):986-95. — View Citation
Cavallaro AM, Lilleby K, Majolino I, Storb R, Appelbaum FR, Rowley SD, Bensinger WI. Three to six year follow-up of normal donors who received recombinant human granulocyte colony-stimulating factor. Bone Marrow Transplant. 2000 Jan;25(1):85-9. — View Citation
Leone AM, Rutella S, Bonanno G, Contemi AM, de Ritis DG, Giannico MB, Rebuzzi AG, Leone G, Crea F. Endogenous G-CSF and CD34+ cell mobilization after acute myocardial infarction. Int J Cardiol. 2006 Aug 10;111(2):202-8. Epub 2005 Jul 26. — View Citation
Semerad CL, Christopher MJ, Liu F, Short B, Simmons PJ, Winkler I, Levesque JP, Chappel J, Ross FP, Link DC. G-CSF potently inhibits osteoblast activity and CXCL12 mRNA expression in the bone marrow. Blood. 2005 Nov 1;106(9):3020-7. Epub 2005 Jul 21. — View Citation
Takahashi T, Kalka C, Masuda H, Chen D, Silver M, Kearney M, Magner M, Isner JM, Asahara T. Ischemia- and cytokine-induced mobilization of bone marrow-derived endothelial progenitor cells for neovascularization. Nat Med. 1999 Apr;5(4):434-8. — View Citation
Takai H, Miyoshi A, Yamazaki M, Adachi K, Katagiri K, Arakawa H, Katsuyama K, Ito T, Fujii E, Hayashi S, Kato A, Suzuki M. Granulocyte colony-stimulating factor has no adverse effects on atherosclerotic lesions in high cholesterol-fed miniature Swine. J Vet Med Sci. 2008 Sep;70(9):943-50. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measuring the pharmacologic increase in of CD31+ (mature endothelial cell) | 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). | 4 months | No |
Secondary | Measureing the pharmacologic increase in CD34+(progenitor cell), | 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). | 4 months | No |
Secondary | Measureing the pharmacologic increase in VEGFR2+ (endothelial progenitor cell) | 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). | 4 months | No |
Secondary | Pharmacologix measurement of nitrite | 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. | 4 months | No |
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