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 peripheral vascular disease.

Condition	Treatment or Intervention	Phase
Peripheral Vascular Diseases	Drug: adult stem cells	Phase I

Further Study Details: 

Primary Outcomes: Adverse events recorded in the 12 week study period; Serious Adverse events recorded for one year
Secondary Outcomes: Changes in limb perfusion after treatment with stem cells will be assessed with arteriography, blood pressure recordings, oxygen measurements, and wound healing
Expected Total Enrollment:  20

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 relief of rest pain or gangrene is amputation.

There is evidence in animal and clinical studies that adult stem cells in the bone marrow, called endothelial progenitor cells, participate in the development of new blood vessels, a process called angiogenesis. In this investigation, patients with limb threatening ischemia will have their bone marrow harvested and the stem cells will then be removed and injected directly into the muscle of the diseased leg. The procedure will require about 4 hours and the subjects will be admitted to the Indiana University Medical Center overnight. The follow-up period is 12 weeks and the analysis will consist of examinations at 1, 2, 4, 6, 8, and 12 weeks. Adverse and serious adverse events will be recorded during this time period. Diagnostic studies will be obtained to measure blood flow in the treated leg during the follow up period and include transcutaneous (skin) oxygen measurements, pressure recordings in the leg, arteriography, magnetic resonance imaging, and wound healing.

Ages Eligible for Study:  21 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Severe peripheral vascular disease not amenable to bypass or angioplasty
• Age >21 years old
• Normal renal function (creatinine < 1.6)

Exclusion Criteria:

• Congestive heart failure (EF<30%)
• History of cancer or myeloproliferative disorders
• Proliferative retinopathy
• Pregnancy
• Cognitively disabled

Please refer to this study by ClinicalTrials.gov identifier  NCT00113243

Michael P Murphy, MD      (317) 630-8288    mipmurph@iupui.edu
Julie Lacy, RN      (317)962-0138    julacy@iupui.edu

Indiana
      Indiana University School of Medicine, Indianapolis,  Indiana,  46202,  United States; Recruiting

Study chairs or principal investigators

Michael P Murphy, MD,  Principal Investigator,  Indiana University School of Medicine   

Study ID Numbers:  IUPUI 0503-14
Record last reviewed:  June 2005
Last Updated:  June 6, 2005
Record first received:  June 6, 2005
ClinicalTrials.gov Identifier:  NCT00113243
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-06-07