Refractory Angina Cell Therapy (ReACT) Involving Autologous Bone Marrow Cells in Patients Without Left Ventricular Dysfunction: A Possible Role for Monocytes

Refractory Angina Cell Therapy (ReACT) Involving Autologous Bone Marrow Cells in Patients Without Left Ventricular Dysfunction: A Possible Role for Monocytes

Author Hossne, Nelson Americo Autor UNIFESP Google Scholar
Invitti, Adriana Luckow Google Scholar
Buffolo, Enio Autor UNIFESP Google Scholar
Azevedo, Silvia Google Scholar
Oliveira, José Salvador Rodrigues de Autor UNIFESP Google Scholar
Stolf, Noedir Groppo Google Scholar
Cruz, L. Eduardo Google Scholar
Sanberg, Paul R. Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Cryopraxis Criobiol Ltda
Cellpraxis Bioengn
Universidade de São Paulo (USP)
Univ S Florida
Abstract Autologous bone marrow mononuclear cell (BMMC) transplantation has emerged as a potential therapeutic option for refractory angina patients. Previous studies have shown conflicting myocardium reperfusion results. the present study evaluated safety and efficacy of CellPraxis Refractory Angina Cell Therapy Protocol (ReACT). in which a specific BMMC formulation was administered as the sole therapy for these patients. the phase I/IIa noncontrolled, open label. clinical trial, involved eight patients with refractory angina and viable ischemic myocardium, without left ventricular dysfunction and who were not suitable for conventional myocardial revascularization. ReACT is a surgical procedure involving a single series of multiple injections (40-90 injections, 0.2 ml each) into ischemic areas of the left ventricle. Primary endpoints were Canadian Cardiovascular Society Angina Classification (CCSAC) improvement at 18 months follow-up and myocardium ischemic area reduction (assessed by scintigraphic analysis) at 12 months follow-up, in correlation with a specific BMMC formulation. Almost all patients presented progressive improvement in angina classification beginning 3 months (p = 0.008) postprocedure which was sustained at 18 months follow-up (p = 0.004), as well as objective myocardium ischemic area reduction at 12 months (decrease of 84.4%, p < 0.004). A positive correlation was found between monocyte concentration and CCSAC improvement (r = -0.759, p < 0.05). Improvement in CCSAC, followed by correlated reduction in scintigraphic myocardium ischemic area, strongly suggests neoangiogenesis as the main stem cell action mechanism. the significant correlation between number of monocytes and improvement strongly supports a cell-related effect of ReACT. ReACT appeared safe and effective.
Keywords Monocytes
Cell therapy
Bone marrow mononuclear cell transplantation
Language English
Sponsor Cryopraxis Crobiologia Ltda.
Cellpraxis Biogenharia
Date 2009-01-01
Published in Cell Transplantation. Elmsford: Cognizant Communication Corp, v. 18, n. 12, p. 1299-1310, 2009.
ISSN 0963-6897 (Sherpa/Romeo, impact factor)
Publisher Cognizant Communication Corp
Extent 1299-1310
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000275146400004

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