Status:
UNKNOWN
Safety Study of Using Stem Cells to Stimulate Development of New Blood Vessels in Peripheral Vascular Disease
Lead Sponsor:
Murphy, Michael P., MD
Collaborating Sponsors:
Indiana University School of Medicine
Conditions:
Peripheral Vascular Diseases
Eligibility:
All Genders
21-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if bone marrow derived adult stem cells are safe and effective in inducing development of new blood vessels (angiogenesis) in the legs of patients with severe...
Detailed Description
Presently there are no effective medical therapies to enhance blood flow in the legs of patients with peripheral vascular disease. For patients with limb threatening ischemia the only option for relie...
Eligibility Criteria
Inclusion
- Severe peripheral vascular disease not amenable to bypass or angioplasty
- Age \>21 years old
- Normal renal function (creatinine \< 1.6)
Exclusion
- Congestive heart failure (ejection fraction \[EF\]\<30%)
- History of cancer or myeloproliferative disorders
- Proliferative retinopathy
- Pregnancy
- Cognitively disabled
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00113243
Start Date
December 1 2004
End Date
December 1 2007
Last Update
June 24 2005
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202