COMPARE CPM-RMI Trial: Intramyocardial transplantation of autologous bone marrow-derived CD133+ Cells and MNCs during CABG in patients with recent MI: A Phase II/III, multicenter, placebo-controlled, randomized, double-blind clinical trial

Naseri, M.H. and Madani, H. and Tafti, S.H.A. and Farahani, M.M. and Saleh, D.K. and Hosseinnejad, H. and Hosseini, S. and Hekmat, S. and Ahmadi, Z.H. and Dehghani, M. and Saadat, A. and Mardpour, S. and Hosseini, S.E. and Esmaeilzadeh, M. and Sadeghian, H. and Bahoush, G. and Bassi, A. and Amin, A. and Fazeli, R. and Sharafi, Y. and Arab, L. and Movahhed, M. and Davaran, S. and Ramezanzadeh, N. and Kouhkan, A. and Hezavehei, A. and Namiri, M. and Kashfi, F. and Akhlaghi, A. and Sotoodehnejadnematalahi, F. and Dizaji, A.V. and Gourabi, H. and Syedi, N. and Shahverdi, A. and Baharvand, H. and Aghdami, N. (2018) COMPARE CPM-RMI Trial: Intramyocardial transplantation of autologous bone marrow-derived CD133+ Cells and MNCs during CABG in patients with recent MI: A Phase II/III, multicenter, placebo-controlled, randomized, double-blind clinical trial. Cell Journal, 20 (2). pp. 267-277.

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COMPARE-CPMRMI-Trial-Intramyocardial-transplantation-of-autologous-bone-marrowderived-CD133-Cells-and-MNCs-during-CABG-in-patients-with-recent-MI-A-Phase-IIIII-multicenter-placebocontrolled-randomized-doubleblind-.pdf

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Abstract

Objective: The regenerative potential of bone marrow-derived mononuclear cells (MNCs) and CD133+ stem cells in the heart varies in terms of their pro-angiogenic effects. This phase II/III, multicenter and double-blind trial is designed to compare the functional effects of intramyocardial autologous transplantation of both cell types and placebo in patients with recent myocardial infarction (RMI) post-coronary artery bypass graft. Materials and Methods: This was a phase II/III, randomized, double-blind, placebo-controlled trial COMPARE CPM-RMI (CD133, Placebo, MNCs - recent myocardial infarction) conducted in accordance with the Declaration of Helsinki that assessed the safety and efficacy of CD133 and MNCs compared to placebo in patients with RMI. We randomly assigned 77 eligible RMI patients selected from 5 hospitals to receive CD133+ cells, MNC, or a placebo. Patients underwent gated single photon emission computed tomography assessments at 6 and 18 months post-intramyocardial transplantation. We tested the normally distributed efficacy outcomes with a mixed analysis of variance model that used the entire data set of baseline and between-group comparisons as well as within subject (time) and group�time interaction terms. Results: There were no related serious adverse events reported. The intramyocardial transplantation of both cell types increased left ventricular ejection fraction by 9 95% confidence intervals (CI): 2.14% to 15.78%, P=0.01 and improved decreased systolic wall thickening by -3.7 (95% CI: -7.07 to -0.42, P=0.03). The CD133 group showed significantly decreased non-viable segments by 75% (P=0.001) compared to the placebo and 60% (P=0.01) compared to the MNC group. We observed this improvement at both the 6- and 18-month time points. Conclusion: Intramyocardial injections of CD133+ cells or MNCs appeared to be safe and efficient with superiority of CD133+ cells for patients with RMI. Although the sample size precluded a definitive statement about clinical outcomes, these results have provided the basis for larger studies to confirm definitive evidence about the efficacy of these cell types (Registration Number: NCT01167751). © 2018 Royan Institute (ACECR). All Rights Reserved.

Item Type: Article
Additional Information: cited By 0
Subjects: WE Musculoskeletal System
WG Cardiovascular System
Depositing User: eprints admin
Date Deposited: 05 Aug 2018 05:45
Last Modified: 14 Sep 2019 06:45
URI: http://eprints.iums.ac.ir/id/eprint/246

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