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
Authors: Mohammad Hassan Naseri, Hoda Madani, Seyed Hossein Ahmadi Tafti, Maryam MoshkaniFarahani, Davood Kazemi-Saleh, Hossein Hosseinnejad, Saeid Hosseini, Sepideh Hekmat, Zargham Hossein Ahmadi, Majid Dehghani, Alireza Saadat, Soura Mardpour, Seyedeh-Esmat Hosseini, Maryam Esmaeilzadeh, Hakimeh Sadeghian, Gholamreza Bahoush, Ali Bassi, Ahmad Amin, Roghayeh Fazeli, Yaser Sharafi, Leila Arab, Mansour Movahhed, Saeid Davaran, Narges Ramezanzadeh, Azam Kouhkan, Ali Hezavehei, Mehrnaz Namiri, Fahimeh Kashfi, Ali Akhlaghi, Fattah Sotoodehnejadnematalahi, Ahmad VosoughDizaji, Hamid Gourabi, Naeema Syedi, Abdolhosein Shahverdi, Hossein Baharvand, Nasser Aghdami
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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).