The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design
Open Access
- 27 September 2011
- journal article
- research article
- Published by Springer Nature in Journal of Translational Medicine
- Vol. 9 (1) , 165
- https://doi.org/10.1186/1479-5876-9-165
Abstract
Autologous bone marrow-derived stem cells have been ascribed an important therapeutic role in No-Option Critical limb Ischemia (NO-CLI). One primary endpoint for evaluating NO-CLI therapy is major amputation (AMP), which is usually combined with mortality for AMP-free survival (AFS). Only a trial which is double blinded can eliminate physician and patient bias as to the timing and reason for AMP. We examined factors influencing AMP in a prospective double-blinded pilot RCT (2:1 therapy to control) of 48 patients treated with site of service obtained bone marrow cells (BMAC) as well as a systematic review of the literature.Keywords
This publication has 25 references indexed in Scilit:
- Early results and lessons learned from a multicenter, randomized, double-blind trial of bone marrow aspirate concentrate in critical limb ischemiaJournal of Vascular Surgery, 2011
- Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemiaThe Lancet, 2011
- Finnvasc score and modified Prevent III score predict long-term outcome after infrainguinal surgical and endovascular revascularization for critical limb ischemiaJournal of Vascular Surgery, 2010
- Cell Therapy, a New Standard in Management of Chronic Critical Limb Ischemia and Foot UlcerCell Transplantation, 2010
- Understanding Objective Performance Goals for Critical Limb Ischemia TrialsSeminars in Vascular Surgery, 2010
- A prognostic model for amputation in critical lower limb ischemiaVascular Medicine, 2009
- Risk stratification in critical limb ischemia: Derivation and validation of a model to predict amputation-free survival using multicenter surgical outcomes dataJournal of Vascular Surgery, 2008
- Resource utilization in the treatment of critical limb ischemia: the effect of tissue loss, comorbidities, and graft-related eventsJournal of Vascular Surgery, 2006
- Parenteral therapy with lipo-ecraprost, a lipid-based formulation of a PGE1 analog, does not alter six-month outcomes in patients with critical leg ischemiaJournal of Vascular Surgery, 2006
- Clinical Outcome and its Predictors in 1560 Patients with Critical Leg IschaemiaEuropean Journal of Vascular and Endovascular Surgery, 1999