Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT02672267
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2016-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Allogeneic Low Oxygen Mesenchymal Bone Marrow Cells in Subjects With Myocardial Infarction
Sponsor:
Altaco XXI, LLP
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: