Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain) - NCT00311805-35211 (Clinical Trial 140649)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy140649.aspx
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| City: |
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Birmingham |
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State:
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AL |
| Zip Code: |
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35211 |
| Conditions: |
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Peripheral Artery Disease - Severe Intermittent Claudication |
| Purpose: |
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The goal of the study is to determine the safety and possible effectiveness of various doses
of autologous (one's own) stem cells, delivered with a needle into the regions of the leg
with poor blood flow in patients with blocked leg arteries that results in claudication
(pain when walking). Stem cells are primitive cells produced by the bone marrow that can
develop into blood cells or other types of cells. In addition to determining whether this
new approach is safe, the diagnostic tests may offer preliminary insights into the
usefulness of this approach for treating intermittent claudication - the condition where
areas in the leg are lacking enough oxygen and blood flow to keep the leg muscle working
well, causing pain and cramping upon walking.
This study is a double-blind, randomized study to compare CD34-positive stem cells versus a
placebo agent (salt water solution known as normal saline). The patient will have a 3:1
chance of their stem cells versus the placebo. Regardless of a patient receiving placebo or
treatment, all patients will undergo all of the pre-treatment phases of this study, which
includes the stem cell mobilization and apheresis procedure.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Males or females equal to or greater than 21 years old
- Patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major
vessel in the affected limb(s) of one or more of the following arteries: superficial
femoral, popliteal, or one or more infrapopliteal arteries, which is/are
non-reconstructable.
- Patients with symptoms of Severe Intermittent Claudication in at least 1 lower limb
persisting for at least 6 months (Rutherford Class 3).
- Patients who have a diagnosis of Peripheral Arterial Disease (PAD) in at least 1
lower limb secondary to atherosclerosis, for at least 6 months.
Exclusion Criteria:
- Patients who have had successful aortic or lower extremity arterial surgery,
angioplasty, or lumbar sympathectomy within 3 month preceding screening.
- Patients with iliac disease amenable to revascularization.
- Patients judged to be a suitable candidate for surgical or percutaneous
revascularization in the limb in which treatment is proposed.
- Patients with Critical Limb Ischemia (CLI), Rutherford Symptom Score of 4,5, or 6.
- Patients in who arterial insufficiency in the lower extremity is the result of a
non-atherosclerotic disorder. |
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| Study is available at: |
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Cardiology, PC
Birmingham, AL 35211
United States
Primary Contact:
Susan DeRamus, RN, CCRC
Email: sderamus@cardiologypc.com
Phone: 205-780-4330 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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