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

Autor: Mohammad Hassan Naseri, Hoda Madani, Seyed Hossein Ahmadi Tafti, Maryam Moshkani Farahani, 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 Vosough Dizaji, Hamid Gourabi,, Naeema Syedi, Abdolhosein Shahverdi, Hossein Baharvand, Nasser Aghdami
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: Cell Journal, Vol 20, Iss 2, Pp 267-277 (2018)
Druh dokumentu: article
ISSN: 2228-5806
2228-5814
DOI: 10.22074/cellj.2018.5197
Popis: 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).
Databáze: Directory of Open Access Journals
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