Intracoronary or Intravenous Infusion Human Wharton' Jelly-derived Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (WJ-ICMP Tria)
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|ClinicalTrials.gov Identifier: NCT02368587|
Recruitment Status : Unknown
Verified January 2015 by Navy General Hospital, Beijing.
Recruitment status was: Not yet recruiting
First Posted : February 23, 2015
Last Update Posted : February 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Cardiomyopathy||Biological: WJMSCs Vs. placebo Biological: Placebo||Phase 2|
Ischemic heart failure (IHF) secondary to myocardial infarction is a common, lethal, disabling, and expensive condition. Despite advances over the last 30 years, the prognosis of patients with IHF remains poor. At present, there has been increasing interest in attempting to repair the failing heart with the use of stem cells, since this approach has the potential to regenerate dead myocardium and thus alleviate the underlying cause of IHF.
A very primitive population of mesenchymal stem cells (MSCs) has been isolated from a continuum from the sub-amnion to perivascular region of umbilical cord, referred to as Wharton's jelly-derived MSCs (WJMSCs). WJMSCs retain a combination of most of their embryonic stem cell (ESC) and MSC markers in primary culture and early passages, thus retaining their multipotent stem cell characteristics. Preclinical studies have demonstrated that WJMSCs can be induced to differentiate into cardiomyocytes and endothelial cells and to integrate into the vasculature and ischemic cardiac tissue, as well as to improve heart function significantly. Therefore, the investigators performed a double-blind, placebo-controlled trial, randomly assigning 160 patients with ischemic heart failure secondary to myocardial infarction to receive an intracoronary or intravenous infusion of WJMSCs or placebo, to investigate the therapeutic safety and efficacy of WJMSCs in patients with ischemic cardiomyopathy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomised, Double-blind, Placebo-controlled, Intracoronary or Intravenous Infusion Human Wharton' Jelly-derived Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||October 2017|
Placebo Comparator: Intracoronary infusion WJMSCs
Intracoronary infusion WJMSCs or placebo in patients with ischemic heart failure
Biological: WJMSCs Vs. placebo
WJMSCs Vs. placebo
Placebo Comparator: Intravenous infusion WJMSCs
Intravenous infusion WJMSCs or placebo in patients with ischemic heart failure.
WJMSCs Vs. placebo
- The primary end point was safety in incidence of adverse events (AEs) within 12 months [ Time Frame: 12 months ]the incidence of adverse events (AEs) within 12 months, including death, nonfatal MI, stroke, hospitalization for worsening heart function, severe arrhythmias, repeated coronary intervention, stent thrombosis, coronary artery microvascular obstruction, immune system disorders, or ectopic tissue formation, was monitored and quantified. Laboratory assays, including biochemical assays, hematologic, tumor and immune indexes and Holter monitoring, were performed at the different follow-up times at 1 months-1 year. The trial will be monitored by a Data and Safety Monitoring Board (DSMB) and the trial will be discontinued in case of safety concerns.
- The secondary end point was efficacy in absolute change of the global LV ejection fraction (LVEF) from baseline to 12 months by MRI [ Time Frame: 12 months ]The secondary end point was efficacy, which was assessed in terms of the absolute change in the global LV ejection fraction (LVEF) from baseline to 12 months post-treatment, as measured by cardiac magnetic resonance imaging (CMRI). Furthermore, CMRI assessments measured scar mass and viable myocardial mass in the left ventricle, scar size, cardiac volumes, global function, regional function, and 6-min walk tests in all patients from baseline to 12 months post-treatment.
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): NCT02368587
|Contact: Yu Chen, MD,PhDfirstname.lastname@example.org|
|Contact: Lian Ru Gao, MDemail@example.com|
|Study Director:||Ning K Zhang, MS||Navy General Hospital|