Evidence map›Paper›PMID 29633605›Full record

ArticleCell journal2018

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.

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 and 26 more

Erratum issued Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Cell journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01167751 (Autologous Bone Marrow Derived Ac 133+ and Mono Nuclear Cells In-patient With Acute Myocardial Infarction During Coronary Artery Bypass Grafting), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01167751 phase3completednot on this map

Autologous Bone Marrow Derived Ac 133+ and Mono Nuclear Cells In-patient With Acute Myocardial Infarction During Coronary Artery Bypass Grafting (CABG): A Randomized Phase III Clinical Trial

TypeinterventionalSponsorRoyan InstituteRan2008 to 2012Enrolled90ConditionsMyocardial InfarctionArmsMNC, AC 133, Control
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Hybrid techniques for myocardial regeneration: state of the art and future perspectives.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2022
    Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. The use of stem cells in ischemic heart disease treatment.Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery · 2018
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

36 authors at 10 institutions in 2 countries.

Mohammad Hassan Naseri *Department of Surgery, Baqiyatallah Hospital, Tehran, Iran.
Hoda Madani *Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Seyed Hossein Ahmadi TaftiResearch Department, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
Maryam Moshkani FarahaniDepartment of Echocardiography, Baqiyatallah Hospital, Tehran, Iran.
Davood Kazemi SalehDepartment of Cardiology, Baqiyatallah Hospital, Tehran, Iran.
Hossein HosseinnejadDepartment of Cardiac Surgery, Lavasani Hospital, Social Security Organization, Tehran, Iran.
Saeid HosseiniRajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.
Sepideh HekmatDepartment of Nuclear Medicine, Hasheminejad Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Zargham Hossein AhmadiTransplantation Research Center, NRITLD, Masih Daneshvari Hospital, Shaheed Beheshti University of Medical Science, Darabad, Niavaran, Tehran, Iran.
Majid DehghaniDepartment of Cardiac Surgery, Lavasani Hospital, Social Security Organization, Tehran, Iran.
Alireza SaadatDepartment of Internal Medicine, Baqiyatallah Hospital, Tehran, Iran.
Soura MardpourDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Seyedeh Esmat HosseiniDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Maryam EsmaeilzadehEchocardiography Research Center, Rajaie Cardiovascular Medical and Research Center , Iran University of Medical Sciences, Tehran, Iran.
Hakimeh SadeghianResearch Department, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
Gholamreza BahoushDepartment of Pediatrics, Ali Asghar Pediatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Ali BassiDepartment of Hematology and Oncology, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
Ahmad AminDepartment of Heart Failure and Transplantation, Fellowship in Heart Failure and Transplantation, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.
Roghayeh FazeliDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Yaser SharafiDepartment of Internal Medicine, Baqiyatallah Hospital, Tehran, Iran.
Leila ArabDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Mansour MovahhedDepartment of Nuclear Medicine, Hasheminejad Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Saeid DavaranResearch Department, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
Narges RamezanzadehResearch Department, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
Azam KouhkanDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Ali HezaveheiDepartment of Internal Medicine, Lavasani Hospital, Social Security Organization, Tehran, Iran.
Mehrnaz NamiriDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Fahimeh KashfiDepartment of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Ali AkhlaghiDepartment of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Fattah SotoodehnejadnematalahiDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Ahmad Vosough DizajiDepartment of Reproductive Imaging, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Hamid GourabiDepartment of Genetics, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Naeema SyediSchool of Pharmacy and Medical Sciences, Sansom Institute for Health Research, University of South Australia, South Australia, Australia.
Abdol Hosein ShahverdiDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Hossein BaharvandDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Nasser AghdamiDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran. Electronic address: Nasser.aghdami@royaninstitute.org.
Academic Center for Education, Culture and Research · IRTehran University of Medical Sciences · IRBaqiyatallah University of Medical Sciences · IRRoyan Institute · IRIran University of Medical Sciences · IRFiroozgar General Hospital · IRHasheminejad Kidney Center · IRMasih Daneshvari Hospital · IRShaheed Rajaei Cardiovascular Medical and Research Center · IRUniversity of South Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe 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

methodsThis 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.

resultsThere 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.

conclusionsIntramyocardial 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).

Indexed as

Autologous TransplantationBone Marrow-CellsCell TherapyMononuclear CellsMyocardial Infarction

Identifiers

PMID29633605
PMCPMC5893299
OpenAlexW2979122122

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.