{ R. Diaz-Garcia MD, J. Bernardo MD Stem Cell Therapy for Patients with Critical Limb Ischemia: A Meta-analysis with Critical Limb Ischemia: A Meta-analysis

Critical Limb ischemia (CLI)  the most severe manifestation of peripheral arterial disease (PAD) Background Description of the Condition

CHRONIC CRITICAL LIMB ISCHEMIA - due to multiple sites of arterial obstruction -Manifestations: (>2 weeks) - ischemic rest pain -Ulceration/gangrene Fontaine & Rutherford classification

Background Description of the Condition CHRONIC CRITICAL LIMB ISCHEMIA -Hemodynamic assessment

ankle systolic pressure of < 50 mm Hg toe systolic pressure of 30 mm Hg ABI <0.4

RISK FACTORS THAT REDUCE BLOOD FLOW Diabetes Mellitus Renal Failure Severely decreased Cardiac Output Smoking Vasospastic disease RISK FACTORS THAT INCREASE BLOOD FLOW Infection Skin Breakdown Trauamatic Injury

Background Description of the Condition ~500 to 1000 million people suffer per year -10% to 40% need to have a limb amputated.

Background Description of the Condition Surgical revascularization Distal crural or pedal bypass Endovascular therapy Maximum podiatric wound care Hyperbaric oxygen Antibiotics Vasodilators

Treatment Goal Increase neovascularization Improve perfusion index Decrease rest pain

Background Description of the Intervention

 direct incorporation and proliferation into the endothelial layer of existing blood vessels  by paracrine effects on mature endothelial cells. Background Description of the Intervention

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Among patients with critical limb ischemia, will stem cell therapy improve peripheral blood flow? Research Question

 To assess the effects of stem cell therapy on critical limb ischemia Objective

SYSTEMATIC SEARCH PUBMED MEDLINE YAHOO 6 STUDIES Key words: Randomized control trials Stem cell therapy Critical limb ischemia 3 STUDIES Huang et al Perin et al Prochazka et al 4 STUDIES INCLUSION /EXCLUSION CRITERIA

STUDY CHARACTERISTICS STUDYPOPULATI ON INTERVEN TION OUTCOMEMETHO DOLOGY COCHRANE CATEGORY Perin et al May 2011 CLI patients ( n=10) Autologous BM progenitor cells ABI at baseline & after 12 weeks RCTB Prochazka et al June 2010 CLI patients (n = 42) Autologous BM Progenitor cells ABI at baseline & after 12 weeks RCTB Huang et al Sept 2005 CLI patients (n=18) Autologouc Peripheral blood Progenitor cells ABI at baseline & after 12 weeks RCTB

Discussion Summary of Main Results

 Stem cell therapy is a promising novel treatment option in CLI patients Conclusion Implications for Practice

 The use of stem cell therapy on a larger population  Future studies on adverse side effects, quality of life and cost effectiveness of treatment  The long term effects of the use of stem cell therapy Conclusion Implications for Research