Bone marrow and stem cell transplantationEffect of Autologous Transplantation of Bone Marrow Cells Concentrated With the MarrowXpress System in Patients With Critical Limb Ischemia
Section snippets
Study Design
The pilot study was designed as nonrandomized noncontrolled phase I trial. We calculated that a sample of 12 patients was required to detect an effect size of 0.70 in the study group (α = 0.05 and β = 0.60). We enrolled 13 patients with PAD who were not candidates for surgical/endovascular procedures or who had experienced prior failed attempts at revascularization.
The diagnosis of limb ischemia was confirmed by angio-TAC and LDF Angio-Tibial artery calcification and Laser Doppler Flowmetry).
Patients' Characteristics
Between September 2009 and March 2011, we treated 13 patients with PAD, including eight males and five females of overall median age of 68.76 ± 16.24 years. The Rutherford classification was used to determine the severity of PAD. Enrolled patients showed symptoms of the disease classified as phase 5 (69%) or 6 (31%), for whom no curative alternatives exist. Usually these patients must undergo limb amputation to avoid gangrene and subsequent death (Table 1).
In 31% of cases, vasculopathy was
Discussion
This pilot study confirmed the beneficial effects of bone marrow cell transplantation in patients with PAD using cell concentration strategies. With the aging of the Western population, PAD in general and CLI in particular is going to become a more demanding problem for health care programs. Many patients unfit for surgery and/or an endovascular approach will face a major amputation, further increasing the social costs of the disease. Intra-arterial infusion of bone marrow-derived stem cells
Conflict of Interest Disclosure
The authors declare no competing financial interests.
Institutional Review Board
The study, coordinated by Professor Sica, has been approved by Ethic Committee of Seconda Universita' di Napoli and registered at Trial Registration, NCT00306085.
Acknowledgments
The authors want to thank Fondazione Banco Napoli, Ministero dell'Università e Ricerca (PRIN), Istituto Superiore di Sanita'. In addition, we are grateful to Dr Paola Mantovano for assistance and Dr Giuseppe Signoriello for helpful discussion.
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