Rationale and design of the transendocardial injection of autologous human cells (bone marrow or mesenchymal) in chronic ischemic left ventricular dysfunction and heart failure secondary to myocardial infarction (TAC-HFT) trial: A randomized, double-blind, placebo-controlled study of safety and efficacy

Barry Trachtenberg, Darcy L. Velazquez, Adam R. Williams, Ian McNiece, Joel Fishman, Kim Nguyen, Didier Rouy, Peter Altman, Richard Schwarz, Adam Mendizabal, Behzad Oskouei, John Byrnes, Victor Soto, Melissa Tracy, Juan Pablo Zambrano, Alan W. Heldman, Joshua M. Hare

Research output: Contribution to journalArticle

Abstract

Although there is tremendous interest in stem cell (SC)-based therapies for cardiomyopathy caused by chronic myocardial infarction, many unanswered questions regarding the best approach remain. The TAC-HFT study is a phase I/II randomized, double-blind, placebo-controlled trial designed to address several of these questions, including the optimal cell type, delivery technique, and population. This trial compares autologous mesenchymal SCs (MSCs) and whole bone marrow mononuclear cells (BMCs). In addition, the study will use a novel helical catheter to deliver cells transendocardially. Although most trials have used intracoronary delivery, the optimal method is unknown and data suggest that the transendocardial approach may have important advantages. Several trials support the benefit of SCs in patients with chronic ischemic cardiomyopathy (ICMP), although the sample sizes have been small and the number of trials sparse. After a pilot phase of 8 patients, 60 patients with ICMP (left ventricular ejection fraction 15%-50%) will be randomized to group A (30 patients further randomized to receive MSC injection or placebo in a 2:1 fashion) or group B (30 patients further randomized to BMCs or placebo in a 2:1 fashion). All patients will undergo bone marrow aspiration and transendocardial injection of SCs or placebo. The primary and secondary objectives are, respectively, to demonstrate the safety and efficacy (determined primarily by cardiac magnetic resonance imaging) of BMCs and MSCs administered transendocardially in patients with ICMP.

Original languageEnglish (US)
Pages (from-to)487-493
Number of pages7
JournalAmerican Heart Journal
Volume161
Issue number3
DOIs
StatePublished - Mar 3 2011
Externally publishedYes

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Trachtenberg, B., Velazquez, D. L., Williams, A. R., McNiece, I., Fishman, J., Nguyen, K., Rouy, D., Altman, P., Schwarz, R., Mendizabal, A., Oskouei, B., Byrnes, J., Soto, V., Tracy, M., Zambrano, J. P., Heldman, A. W., & Hare, J. M. (2011). Rationale and design of the transendocardial injection of autologous human cells (bone marrow or mesenchymal) in chronic ischemic left ventricular dysfunction and heart failure secondary to myocardial infarction (TAC-HFT) trial: A randomized, double-blind, placebo-controlled study of safety and efficacy. American Heart Journal, 161(3), 487-493. https://doi.org/10.1016/j.ahj.2010.11.024