Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT02672267
Brief Summary:
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of human allogeneic ischemia tolerant mesenchymal bone marrow cells (aLoOxMBMC) administered intravenously to subjects with Acute Myocardial Infarction (STEMI, non STEMI).
Detailed Description:
Cardiovascular disease (CVD) remains a leading cause of morbidity and mortality despite continuing advances in various treatment options. In developed countries, ischemic heart disease causes more than 50% of all cardiovascular deaths.
Stem cell transplantation has the potential to repair and improve cardiac function, thus helping to significantly decrease morbidity and mortality rates. Preclinical data from a variety of animal studies demonstrated the capacity for skeletal myoblasts to engraft, form myotubules, and enhance cardiac function after transplantation into infarcted myocardium. The underlying sequela of the post infarcted left ventricle often includes massive damage to the cardiomyocyte. The left ventricle remodeling (dilation) and dysfunction is thought to be irreversible. The development of treatments that will regenerate its musculature and vascular components is now considered a main therapeutic challenge. Preliminary human studies focusing on subjects with ischemic heart disease have demonstrated successful myoblast transplantation into the post infarction scar. Another study demonstrated the benefits of stem cell therapy on ventricular function and profusion.
Allogeneic mesenchymal stem cells have been used in a number of clinical trials for different indications. These clinical trials showed excellent safety, reduction in arrhythmias, improvement in functional status and increased ejection fraction.
The hMSCs are able to:
1. Prevent reperfusion injury;
2. Prevent excessive fibrosis;
3. Reestablish function of hibernating cardiomyocytes in peripheral zone area.
4. Reestablish angiogenesis/vasculogenesis;
5. Preserve wall motion (prevent arrhythmia and functional contractile deterioration);
6. Prevent post infarct ventricular remodeling and left ventricular dilation. It is well accepted that dilated cardiomyopathy mortality rates are 50% within 5 years of diagnosis;
7. Limit infarct size. If we can preserve and restore cardiac function as measured by ejection fraction and LVESV preserving left ventricular integrity would increase subject quality of life as well as longevity.
Study:
NCT02672267
Study Brief:
Protocol Section:
NCT02672267