title: A phase II trial of autologous transplantation of bone marrow stem cells for critical limb ischemia: results of the Naples and Pietra Ligure Evaluation of Stem Cells study.
abstract: Critical limb ischemia (CLI) is a vascular disease affecting lower limbs, which is going to become a demanding challenge because of the aging of the population. Despite advances in endovascular therapies, CLI is associated with high morbidity and mortality. Patients without direct revascularization options have the worst outcomes. To date, 25%-40% of CLI patients are not candidates for surgical or endovascular approaches, ultimately facing the possibility of a major amputation. This study aimed to assess the safety and efficacy of autologous bone marrow (BM) transplantation performed in "no-option" patients, in terms of restoring blood perfusion by collateral flow and limb salvage. A multicenter, prospective, not-controlled phase II study for no-option CLI patients was performed. Patients were subjected to intra-arterial infusion of autologous bone marrow and followed for 12 months after the treatment. Variation of blood perfusion parameters, evaluated by laser Doppler flowmetry or transcutaneous oximetry, was set as the primary endpoint at 12 months after treatment and amputation-free survival as the secondary endpoint. Sixty patients were enrolled and treated with BM transplantation, showing improvement in objective and subjective measures of perfusion. Furthermore, survival analysis demonstrated improved amputation-free survival rates (75.2%) at 12 months after the treatment. This study provides further evidence that autologous bone marrow transplantation is well tolerated by CLI patients without adverse effects, demonstrating trends toward improvement in perfusion and reduced amputation rate, confirming the feasibility and safety of the procedure.
authors.affiliation: Department of Vascular Surgery, Azienda Ospedaliera Santa Corona, Pietra Ligure, Italy. aleschiavetta@libero.it
authors.forename: Alessandro
authors.initials: A
authors.lastname: Schiavetta
authors.forename: Ciro
authors.initials: C
authors.lastname: Maione
authors.forename: Chiara
authors.initials: C
authors.lastname: Botti
authors.forename: Gennaro
authors.initials: G
authors.lastname: Marino
authors.forename: Stefano
authors.initials: S
authors.lastname: Lillo
authors.forename: Alberto
authors.initials: A
authors.lastname: Garrone
authors.forename: Lorella
authors.initials: L
authors.lastname: Lanza
authors.forename: Stefano
authors.initials: S
authors.lastname: Pagliari
authors.forename: Andrea
authors.initials: A
authors.lastname: Silvestroni
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Signoriello
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Sica
authors.forename: Gilda
authors.initials: G
authors.lastname: Cobellis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001783:Blood Flow Velocity; D016026:Bone Marrow Transplantation; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007511:Ischemia / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D007558:Italy; D017078:Laser-Doppler Flowmetry / Q000379:methods; D035002:Lower Extremity / Q000098:blood supply* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020127:Recovery of Function; D033581:Stem Cell Transplantation; D015996:Survival Rate; D014182:Transplantation, Autologous