Status:
COMPLETED
Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
Lead Sponsor:
Vericel Corporation
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia. The doubl...
Detailed Description
The study will assess the safety and ability of Aastrom TRC autologous bone marrow cells to restore peripheral blood flow affected by critical limb ischemia. Peripheral arterial disease (PAD), also k...
Eligibility Criteria
Inclusion
- Males and females, 18-90 years of age
- Diagnosis of CLI
- Infrainguinal occlusive disease, without options for revascularization
- No surgical interventions planned
- Life expectancy of 2 years
- Normal organ and marrow function
- Patients with controlled blood pressure (≤ 180/110 mmHg) and established anti-hypertensive therapy
- Established anti-platelet therapy
Exclusion
- Poorly controlled diabetes mellitus (hemoglobin A1c \[HbA1c\] \> 10%)
- Aortoiliac disease with \> 50% stenosis
- Wounds with severity greater than Grade 3 on the Wagner Scale
- Any known failed ipsilateral revascularization within 2 weeks of enrollment
- Previous amputation of the talus, or above in the target limb
- Life-threatening ventricular arrhythmia; unstable angina; or, myocardial infarction within 4 weeks of enrollment
- Severe congestive heart failure (CHF) (i.e. New York Heart Association \[NYHA\] Stage IV)
- Receiving treatment with hematopoietic growth factors
- Infection of the involved extremity(ies)
- Active wet gangrenous tissue
- Require uninterruptible anticoagulation therapy
- Blood clotting disorder
- Cancer
- End stage renal disease requiring dialysis for more than 6 months prior to enrollment
- Pregnant or lactating
- Having received medication for thrombolytic therapy (e.g. rTPA or other enzymatic clot busters) within 30 days prior to enrollment
- Undergoing hyperbaric oxygen treatment within 2 weeks of enrollment
- Concomitant wound treatments with growth factors or tissue engineered products
- Receiving anti-angiogenic drugs
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00468000
Start Date
April 1 2007
End Date
March 1 2011
Last Update
May 20 2020
Active Locations (20)
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1
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
2
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
Malcolm Randall Veterans Administration Medical Center, part of the North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608