COMPARE CPM-RMI Trial: Intramyocardial Transplantation of Autologous Bone Marrow-derived CD133+ Cells and Mononuclear Cells during Coronary Artery Bypass Grafting in Patients with Recent Myocardial Infarction: A Phase II/III, Multicenter, Placebo-Controlled, Randomized, Double-Blind Clinical Trial

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...

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Published in:Cell journal (Yakhteh) 2018-07, Vol.20 (2), p.267
Main Authors: Mohammad Hassan Naseri, Madani, Hoda, Seyed Hossein Ahmadi Tafti, MoshkaniFarahani, Maryam, Kazemi-Saleh, Davood, Hosseinnejad, Hossein, Hosseini, Saeid, Hekmat, Sepideh, Zargham Hossein Ahmadi, Dehghani, Majid, Saadat, Alireza, Soura Mardpour, Hosseini, Seyedeh-Esmat, Esmaeilzadeh, Maryam, Sadeghian, Hakimeh, Bahoush, Gholamreza, Bassi, Ali, Amin, Ahmad, Fazeli, Roghayeh, Sharafi, Yaser, Arab, Leila, Movahhed, Mansour, Davaran, Saeid, Ramezanzadeh, Narges, Kouhkan, Azam, Hezavehei, Ali, Namiri, Mehrnaz, Kashfi, Fahimeh, Akhlaghi, Ali, Fattah Sotoodehnejadnematalahi, VosoughDizaji, Ahmad, Gourabi, Hamid, Syedi, Naeema, Shahverdi, Abdolhosein, Baharvand, Hossein, Aghdami, Nasser
Format: Article
Language:English
Subjects:
Angiogenesis
Autografts
Bone marrow
Bone marrow transplantation
Clinical trials
Computed tomography
Confidence intervals
Coronary artery
Coronary vessels
Double-blind studies
Effectiveness
Emission analysis
Heart
Heart attacks
Heart failure
Heart surgery
Hepatitis
Laboratories
Leukocytes (mononuclear)
Medical diagnosis
Myocardial infarction
NMR
Nuclear magnetic resonance
Patients
Photon emission
Randomization
Single photon emission computed tomography
Stem cells
Systematic review
Thickening
Transplantation
Variance analysis
Ventricle
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Summary: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).
ISSN:2228-5806
2228-5814
DOI:10.22074/cellj.2018.5197