Status:
UNKNOWN
Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain)
Lead Sponsor:
Losordo, Douglas, M.D.
Conditions:
Peripheral Artery Disease
Severe Intermittent Claudication
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00311805
Start Date
April 1 2006
Last Update
March 31 2015
Active Locations (2)
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1
Cardiology, PC
Birmingham, Alabama, United States, 35211
2
Northwestern University
Chicago, Illinois, United States, 60611