Efficacy of stem cell in improvement of left ventricular function in acute myocardial infarction - MI3 Trial

Autor: Prosenjit Ganguli, Sanjay Gambhir, Balram Airan, Hemant Madan, Jacob Jose, Shinjini Bhatnagar, Paul V George, Oomen K George, Rajat Datta, Aditi Pandit, Prashant Bharadwaj, Sujata Mohanty, Naveen Garg, Balram Bhargava, Mi Trial, Pravin K. Goel, Anish Bhatacharya, Sunil Thomas Chandy, Ajay Bahl, Vikram Mathews, Ritwik Sarkar, M J Jacob, Velu Nair, Kewal K. Talwar, Alka Sharma, Neelam Marwah, Chetan Patel, Soniya Nityanand, A. Srivastava, Sunil Sofat, A S Mondal
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Male
medicine.medical_specialty
medicine.medical_treatment
Myocardial Infarction
India
lcsh:Medicine
Acute myocardial infarction
stem cell therapy
General Biochemistry
Genetics and Molecular Biology
law.invention
Ventricular Dysfunction
Left
Randomized controlled trial
Bone Marrow
law
Internal medicine
Post-hoc analysis
medicine
Humans
multicentrial-trial in India
Myocardial infarction
cardiovascular diseases
Aged
autologous bone marrow derived mononuclear cells
Ejection fraction
MI3: mononuclear infusion in myocardial infarction
business.industry
Stem Cells
ST elevation
lcsh:R
Percutaneous coronary intervention
left ventricular ejection fraction
General Medicine
Middle Aged
medicine.disease
Clinical trial
Treatment Outcome
Echocardiography
Conventional PCI
Cardiology
Acute myocardial infarction - autologous bone marrow derived mononuclear cells - left ventricular ejection fraction - MI3: mononuclear infusion in myocardial infarction - multicentrial-trial in India - stem cell therapy
Female
Original Article
business
Stem Cell Transplantation
Zdroj: Indian Journal of Medical Research, Vol 142, Iss 2, Pp 165-174 (2015)
The Indian Journal of Medical Research
ISSN: 0971-5916
Popis: Background & objectives: Acute myocardial infarction (AMI) is characterized by irreparable and irreversible loss of cardiac myocytes. Despite major advances in the management of AMI, a large number of patients are left with reduced left ventricular ejection fraction (LVEF), which is a major determinant of short and long term morbidity and mortality. A review of 33 randomized control trials has shown varying improvement in left ventricular (LV) function in patients receiving stem cells compared to standard medical therapy. Most trials had small sample size and were underpowered. This phase III prospective, open labelled, randomized multicenteric trial was undertaken to evaluate the efficacy in improving the LVEF over a period of six months, after injecting a predefined dose of 5-10 Χ 10 [8] autologous mononuclear cells (MNC) by intra-coronary route, in patients, one to three weeks post ST elevation AMI, in addition to the standard medical therapy. Methods: In this phase III prospective, multicentric trial 250 patients with AMI were included and randomized into stem cell therapy (SCT) and non SCT groups. All patients were followed up for six months. Patients with AMI having left ventricular ejection fraction (LVEF) of 20-50 per cent were included and were randomized to receive intracoronary stem cell infusion after successfully completing percutaneous coronary intervention (PCI). Results: On intention-to-treat analysis the infusion of MNCs had no positive impact on LVEF improvement of ≥ 5 per cent. The improvement in LVEF after six months was 5.17 ± 8.90 per cent in non SCT group and 4.82 ± 10.32 per cent in SCT group. The adverse effects were comparable in both the groups. On post hoc analysis it was noted that the cell dose had a positive impact when infused in the dose of ≥ 5 X 10 [8] (n=71). This benefit was noted upto three weeks post AMI. There were 38 trial deviates in the SCT group which was a limitation of the study. Interpretation & conclusions:Infusion of stem cells was found to have no benefit in ST elevation AMI. However, the procedure was safe. A possible benefit was seen when the predefined cell dose was administered which was noted upto three weeks post AMI, but this was not significant and needs confirmation by larger trials.
Databáze: OpenAIRE
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