Elsevier

Transplantation Proceedings

Volume 45, Issue 1, January–February 2013, Pages 402-406
Transplantation Proceedings

Bone marrow and stem cell transplantation
Effect of Autologous Transplantation of Bone Marrow Cells Concentrated With the MarrowXpress System in Patients With Critical Limb Ischemia

https://doi.org/10.1016/j.transproceed.2012.10.031Get rights and content

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.

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.

References (14)

There are more references available in the full text version of this article.

Cited by (9)

View all citing articles on Scopus
View full text
Copyright © 2013 Elsevier Inc. All rights reserved.