Rationale and design for TIME

A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction

Jay H. Traverse, Timothy D. Henry, Douglas E. Vaughn, Stephen G. Ellis, Carl J. Pepine, James T. Willerson, David X M Zhao, Linda B. Piller, Marc S. Penn, Barry J. Byrne, Emerson C. Perin, Adrian P. Gee, Antonis K. Hatzopoulos, David H. McKenna, John R. Forder, Doris A. Taylor, Christopher R. Cogle, Rachel E. Olson, Beth C. Jorgenson, Shelly L. Sayre & 5 others Rachel W. Vojvodic, David J. Gordon, Sonia I. Skarlatos, Lemuel A. Moye', Robert D. Simari

Research output: Contribution to journalArticle

61 Citations (Scopus)

Abstract

Several previous studies have demonstrated that administration of autologous bone marrow-derived mononuclear cells (BMMNCs) improves cardiac function in patients after acute myocardial infarction (AMI). However, optimum timing of administration has not been investigated in a clinical trial. The Cardiovascular Cell Therapy Research Network was developed and funded by the National Heart, Lung, and Blood Institute to address important questions such as timing of cell delivery and to accelerate research in the use of cell-based therapies. The TIME trial is a randomized, phase II, double-blind, placebo-controlled clinical trial. The 5 member clinical sites of the Cardiovascular Cell Therapy Research Network will enroll 120 eligible patients with moderate-to-large anterior AMIs who have undergone successful percutaneous coronary intervention of the left anterior descending coronary artery and have a left ventricular (LV) ejection fraction ≤45% by echocardiography. Participants will have bone marrow aspirations and intracoronary infusions of 150 × 106 BMMNCs or placebo on day 3 or day 7 post-AMI. Objectives of this study are (1) to evaluate effects of BMMNCs on regional and global LV function compared to placebo therapy in patients with acute AMI as assessed by cardiac magnetic resonance imaging at 6 months and (2) to assess whether effects of BMMNC infusion on global and regional LV function and safety are influenced by the time of administration. This study will provide further insight into the clinical feasibility and appropriate timing of autologous BMMNC therapy in high-risk patients after AMI and percutaneous coronary intervention.

Original languageEnglish (US)
Pages (from-to)356-363
Number of pages8
JournalAmerican Heart Journal
Volume158
Issue number3
DOIs
StatePublished - Sep 2009

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Bone Marrow Cells
Bone Marrow
Myocardial Infarction
Placebos
Cell- and Tissue-Based Therapy
Safety
Percutaneous Coronary Intervention
Left Ventricular Function
Research
National Heart, Lung, and Blood Institute (U.S.)
Controlled Clinical Trials
Stroke Volume
Echocardiography
Coronary Vessels
Magnetic Resonance Imaging
Clinical Trials

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Rationale and design for TIME : A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction. / Traverse, Jay H.; Henry, Timothy D.; Vaughn, Douglas E.; Ellis, Stephen G.; Pepine, Carl J.; Willerson, James T.; Zhao, David X M; Piller, Linda B.; Penn, Marc S.; Byrne, Barry J.; Perin, Emerson C.; Gee, Adrian P.; Hatzopoulos, Antonis K.; McKenna, David H.; Forder, John R.; Taylor, Doris A.; Cogle, Christopher R.; Olson, Rachel E.; Jorgenson, Beth C.; Sayre, Shelly L.; Vojvodic, Rachel W.; Gordon, David J.; Skarlatos, Sonia I.; Moye', Lemuel A.; Simari, Robert D.

In: American Heart Journal, Vol. 158, No. 3, 09.2009, p. 356-363.

Research output: Contribution to journalArticle

Traverse, JH, Henry, TD, Vaughn, DE, Ellis, SG, Pepine, CJ, Willerson, JT, Zhao, DXM, Piller, LB, Penn, MS, Byrne, BJ, Perin, EC, Gee, AP, Hatzopoulos, AK, McKenna, DH, Forder, JR, Taylor, DA, Cogle, CR, Olson, RE, Jorgenson, BC, Sayre, SL, Vojvodic, RW, Gordon, DJ, Skarlatos, SI, Moye', LA & Simari, RD 2009, 'Rationale and design for TIME: A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction', American Heart Journal, vol. 158, no. 3, pp. 356-363. https://doi.org/10.1016/j.ahj.2009.06.009
Traverse, Jay H. ; Henry, Timothy D. ; Vaughn, Douglas E. ; Ellis, Stephen G. ; Pepine, Carl J. ; Willerson, James T. ; Zhao, David X M ; Piller, Linda B. ; Penn, Marc S. ; Byrne, Barry J. ; Perin, Emerson C. ; Gee, Adrian P. ; Hatzopoulos, Antonis K. ; McKenna, David H. ; Forder, John R. ; Taylor, Doris A. ; Cogle, Christopher R. ; Olson, Rachel E. ; Jorgenson, Beth C. ; Sayre, Shelly L. ; Vojvodic, Rachel W. ; Gordon, David J. ; Skarlatos, Sonia I. ; Moye', Lemuel A. ; Simari, Robert D. / Rationale and design for TIME : A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction. In: American Heart Journal. 2009 ; Vol. 158, No. 3. pp. 356-363.
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AU - Traverse, Jay H.

AU - Henry, Timothy D.

AU - Vaughn, Douglas E.

AU - Ellis, Stephen G.

AU - Pepine, Carl J.

AU - Willerson, James T.

AU - Zhao, David X M

AU - Piller, Linda B.

AU - Penn, Marc S.

AU - Byrne, Barry J.

AU - Perin, Emerson C.

AU - Gee, Adrian P.

AU - Hatzopoulos, Antonis K.

AU - McKenna, David H.

AU - Forder, John R.

AU - Taylor, Doris A.

AU - Cogle, Christopher R.

AU - Olson, Rachel E.

AU - Jorgenson, Beth C.

AU - Sayre, Shelly L.

AU - Vojvodic, Rachel W.

AU - Gordon, David J.

AU - Skarlatos, Sonia I.

AU - Moye', Lemuel A.

AU - Simari, Robert D.

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