A Study of Allogeneic Low Oxygen Mesenchymal Bone Marrow Cells in Subjects With Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT02672267|
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : October 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Biological: Stem cells Other: Placebo||Phase 3|
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:
- Prevent reperfusion injury;
- Prevent excessive fibrosis;
- Reestablish function of hibernating cardiomyocytes in peripheral zone area.
- Reestablish angiogenesis/vasculogenesis;
- Preserve wall motion (prevent arrhythmia and functional contractile deterioration);
- 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;
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||A Phase III, Double-blinded, Single Center, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Single Intravenous Dose of Allogeneic Ischemia Tolerant Human Mesenchymal Bone Marrow Cells to Subjects With Acute Myocardial Infarction|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Stem Cells
Experimental: Stem Cells ALLOGENEIC LOW OXYGEN MESENCHYMAL BONE MARROW CELLS Intervention: Biological: Stem cells
Biological: Stem cells
human Allogeneic Low Oxygen mesenchymal stem cells; Ischemia tolerant
Other Name: Allogeneic Low Oxygen mesenchymal stem cells
Placebo Comparator: Placebo
Lactated Ringer's Solution
Lactated Ringer's Solution
- The safety and tolerability of aMBMC intravenous administration during the six month study period as determined by major adverse events MACE endpoint [ Time Frame: 6 months ]
- The change from baseline on physical exam conducted at 1, 3 and 6 months post-administration [ Time Frame: 6 months ]
- LV end diastolic volume [ Time Frame: 3 months ]measured by MRI
- LV end systolic volume [ Time Frame: 3 months ]measured by MRI
- Infarct size measured by MRI, with contrast [ Time Frame: 3 months ]measured by MRI
- Global Left Ventricular Ejection Fraction [ Time Frame: 3 months ]measured by MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672267
|National Research Medical Center|
|Astana, Kazakhstan, 010000|
|Principal Investigator:||Saule Abseitova, MD, Prof.||National Research Medical Center|
|Study Director:||Daniyar Jumaniyazov, MD, PhD||Altaco XXI, LLP|