Title of article :
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
Author/Authors :
Naseri ، Mohammad Hassan - Baqiyatallah Hospital , Madani ، Hoda - Academic Center for Education, Culture and Research (ACECR) , Ahmadi Tafti ، Hossein - Tehran University of Medical Sciences , Moshkani Farahani ، Maryam - Baqiyatallah Hospital , Kazemi Saleh ، Davood - Baqiyatallah Hospital , Hosseinnejad ، Hossein - Social Security Organization , Hosseini ، Saeid - Iran University of Medical Sciences , Hekmat ، Sepideh - Tehran University of Medical Sciences , Hossein Ahmadi ، Zargham - Shaheed Beheshti University of Medical Science , Dehghani ، Majid - Social Security Organization , Saadat ، Alireza - Baqiyatallah Hospital , Mardpour ، Soura - Academic Center for Education, Culture and Research (ACECR) , Hosseini ، Esmat - Academic Center for Education, Culture and Research (ACECR) , Esmaeilzadeh ، Maryam - Iran University of Medical Sciences , Sadeghian ، Hakimeh - Tehran University of Medical Sciences , Bahoush ، Gholamreza - Tehran University of Medical Sciences , Bassi ، Ali - Iran University of Medical Sciences , Amin ، Ahmad , Fazeli ، Roghayeh - Academic Center for Education, Culture and Research (ACECR) , Sharafi ، Yaser - Baqiyatallah Hospital , Arab ، Leila - Academic Center for Education, Culture and Research (ACECR) , Movahhed ، Mansour - Tehran University of Medical Sciences , Davaran ، Saeid - Tehran University of Medical Sciences , Ramezanzadeh ، Narges - Tehran University of Medical Sciences , Kouhkan ، Azam - Academic Center for Education, Culture and Research (ACECR) , Hezavehei ، Ali - Social Security Organization , Namiri ، Mehrnaz - Academic Center for Education, Culture and Research (ACECR) , Kashfi ، Fahimeh - Academic Center for Education, Culture and Research (ACECR) , Akhlaghi ، Ali - Academic Center for Education, Culture and Research (ACECR) , Sotoodehnejadnematalahi ، Fattah - Academic Center for Education, Culture and Research (ACECR) , Vosough Dizaji ، Ahmad - Academic Center for Education, Culture and Research ( ACECR) , Gourabi ، Hamid - Academic Center for Education, Culture and Research (ACECR) , Syedi ، Naeema - University of South Australia , Shahverdi ، Abdolhosein - Academic Center for Education, Culture and Research (ACECR) , Baharvand ، Hossein - Academic Center for Education, Culture and Research (ACECR) , Aghdami ، Nasser - Academic Center for Education, Culture and Research (ACECR)
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).
Keywords :
Autologous Transplantation , Bone MarrowCells , Cell Therapy , Mononuclear , Cells , Myocardial Infarction
