Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI) - NCT00951210-27710 (Clinical Trial 304532)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy304532.aspx
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Durham |
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State:
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NC |
| Zip Code: |
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27710 |
| Conditions: |
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Peripheral Artery Disease - Peripheral Vascular Disease - Critical Limb Ischemia |
| Purpose: |
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The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections
for the treatment of CLI patients.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. Diagnosis of critical limb ischemia defined as persistent, recurring ischemic rest
pain for at least two (2) weeks, and/or ulceration or gangrene of the foot or toe,
with ABI < 0.6 or/and TBI < 0.4
2. Rutherford category 4-5
3. Non candidate for revascularization or endovascular intervention based on unfavorable
vascular anatomy or significant co-morbid medical conditions as confirmed by vascular
study (e.g., angiogram, MRA) obtained within 3 months prior screening visit and
signed approval of vascular surgeon. The decision to classify the subject as a
non-candidate will be made by the investigator and confirmed by an independent third
party vascular surgeon who is not participating in the study.
4. In the opinion of the investigator, major amputation is not anticipated over a period
of three (3) months.
5. Those diabetic subjects who are on optimal diabetes medication, with an HbA1c < 8%
Exclusion Criteria:
1. Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic
blood pressure > 180 mmHg during screening).
2. Wounds with severity greater than Grade 2 on the Wagner Scale
3. Life-threatening ventricular arrhythmia - except if an ICD is implanted - or unstable
angina - characterized by increasingly frequent episodes with modest exertion or at
rest, worsening severity, and prolonged.
4. ST segment elevation myocardial infarction and/or TIA/CVA within six (6) months prior
to enrollment.Patients with severe congestive heart failure (i.e. NYHA Stage IV)
5. In the opinion of the investigator, the patient is unsuitable for cellular therapy. |
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| Study is available at: |
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Duke University Medical Center
Durham, NC 27710
United States
Primary Contact:
Kim L. McIntosh, LPN
Email: kim.mcintosh@duke.edu
Phone: 919-681-5072 |
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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 16, 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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