A Protocol for a Phase I/II Trial to Evaluate Safety and Efficacy of Autologous Stem Cells Embedded in a Nanogel Patch for Patients with Heart Failure Undergoing Coronary Artery Bypass Graft

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Carlos Vergara-Sanchez
Angela Dominguez-Rodriguez
Judith A Vasquez
Gustavo A Grandez-Castillo
Ahmed A Elyas
David Hernandez-Herrero
Jennifer C Eaton
Tamar DuBois
Andrea Schilling-Redlich
Carolina Ogawa-Matsubayashi
Amarilis Then-Paulino
Ana Cecilia Scultori S Teles
Eduardo Yamaguchi
Felipe F. Gonzalez
Johnny Camargo
Marianne Nakai
Maryam M Aldosari
Oriol Baptiste-Sainvil
Rafael Augusto Paes-Lima-Rocha
Renata Meneguetti
Sílvia Corradi Faria de Medeiros
Weiguo Yao
Walla Abdalla-Mohamed
Iona Cosgarea
Ludmilla Candido-Santos
Yuri Takehara-Chemale
Rami Nassir
Gelanys Castro-Tejada
Mayumi Toyama
Olivier F Clerc
Alma Sanchez-Jimenez


Introduction: Heart failure affects numerous patients and carries a 50% 5-year mortality rate from the time of diagnosis. Current treatment is based on medication, device therapy and revascularization to reduce morbidity and mortality. However, stem cell therapy could improve cardiac function and outcomes, using a nanogel patch during coronary bypass graft. Methods: An open label phase I/II trial consisting of an initial sentinel approach to test safety, followed by a randomized approach to test efficacy. Discussion: Preclinical studies have shown safety of nanogel patches and clinical trials showed promise using mesenchymal stem cells. New approaches could contribute to the improvement of morbidity and mortality. Mesenchymal stem cell implantation with a nanogel patch could represent an effective and innovative therapeutic approach for patients with heart failure and reduced ejection fraction

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Vergara-Sanchez, C., Dominguez-Rodriguez, A., Vasquez, J. A., Grandez-Castillo, G. A., Elyas, A. A., Hernandez-Herrero, D., Eaton, J. C., DuBois, T., Schilling-Redlich, A., Ogawa-Matsubayashi, C., Then-Paulino, A., Scultori S Teles, A. C., Yamaguchi, E., Gonzalez, F. F., Camargo, J., Nakai, M., Aldosari, M. M., Baptiste-Sainvil, O., Paes-Lima-Rocha, R. A., Meneguetti, R., Faria de Medeiros, S. C., Yao, W., Abdalla-Mohamed, W., Cosgarea, I., Candido-Santos, L., Takehara-Chemale, Y., Nassir, R., Castro-Tejada, G., Toyama, M., Clerc, O. F., & Sanchez-Jimenez, A. (2020). A Protocol for a Phase I/II Trial to Evaluate Safety and Efficacy of Autologous Stem Cells Embedded in a Nanogel Patch for Patients with Heart Failure Undergoing Coronary Artery Bypass Graft. Principles and Practice of Clinical Research, 6(1), 15–22. Retrieved from https://journal.ppcr.org/index.php/ppcrjournal/article/view/99
Clinical Research Design
Author Biographies

Jennifer C Eaton, Institute for Family Health

ECRIP fellow/Physican

Amarilis Then-Paulino, Ministerio de Salud Pública, Dominican Republic

Coordinadora del Programa de Investigación en Nutrición

Ludmilla Candido-Santos, Massachusetts General Hospital, Harvard Medical School

Emergency Medicine Network

Olivier F Clerc, University Hospital Basel, Switzerland

Department of Cardiology

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