Effect of Autologous Transplantation of Bone Marrow Cells Concentrated With the MarrowXpress System in Patients With Critical Limb Ischemia

Abstract Critical limb ischemia (CLI), a vascular disease affecting lower limbs, with high morbidity and mortality, is becoming a challenge due to the aging of the population. Patients without direct revascularization options have the worst outcomes. To date, 25% to 40% of CLI patients are not candi...

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Published inTransplantation proceedings Vol. 45; no. 1; pp. 402 - 406
Main Authors Maione, C, Botti, C, Coppola, C.A, Silvestroni, C, Lillo, S, Schiavone, V, Sica, G, Sica, V, Kumar, V, Cobellis, G
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 2013
Subjects
Adult
Aged
Aged, 80 and over
Blood Flow Velocity
Bone Marrow - pathology
Bone Marrow Transplantation - methods
Extremities - pathology
Female
Flow Cytometry
Follow-Up Studies
Humans
Ischemia - pathology
Leukocytes, Mononuclear - cytology
Male
Middle Aged
Peripheral Arterial Disease - pathology
Pilot Projects
Surgery
Transplantation, Autologous - methods
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Summary:Abstract Critical limb ischemia (CLI), a vascular disease affecting lower limbs, with high morbidity and mortality, is becoming a challenge due to the aging of the population. Patients without direct revascularization options have the worst outcomes. To date, 25% to 40% of CLI patients are not candidates for surgical or endovascular approaches, facing a major amputation as the ultimate option. This study sought to assess the safety and efficacy of transplantation of autologous bone marrow concentrates in “no-option” patients to restore blood perfusion by collateral flow and limb salvage. We performed a nonrandomized, noncontrolled pilot study for no-option CLI patients using intra-arterial infusion of autologous bone marrow concentrate. Variation of blood perfusion parameters, evaluated by laser doppler flowmetry after 6 and 12 months, was set as primary endpoint. Thirteen enrolled patients showed improvements in objective measurements of perfusion. This uncontrolled study provided evidence that transplantation of autologous bone marrow concentrates was well tolerated by CLI patients without significant adverse effects, demonstrating improved perfusion, confirming the feasibility and safety of the procedure.
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ISSN:0041-1345
1873-2623
DOI:10.1016/j.transproceed.2012.10.031