Intracoronary or Intravenous Infusion Human Wharton' Jelly-derived Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy

NCT02368587 | Unknown Phase 2 DMC

• 1 other identifier: NavyGHB
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the safety and efficacy of intracoronary or intravenous infusion human umbilical Wharton's jelly-derived Mesenchymal Stem Cell (WJMSC) in patients with ischemic cardiomyopathy secondary to myocardial infarction.

Conditions

Ischemic Cardiomyopathy

Keywords

intracoronary infusion; intravenous infusion; Wharton's jelly-derived mesenchymal stem cells; ischemic Cardiomyopathy; heart function

Outcome Measures

Primary Outcomes (1)

• The primary end point was safety in incidence of adverse events (AEs) within 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.

  12 months

Secondary Outcomes (1)

• The secondary end point was efficacy in absolute change of the global LV ejection fraction (LVEF) from baseline to 12 months by MRI

  12 months

Study Arms (2)

Intracoronary infusion WJMSCs

PLACEBO COMPARATOR

Intracoronary infusion WJMSCs or placebo in patients with ischemic heart failure

Biological: WJMSCs Vs. placebo

Intravenous infusion WJMSCs

PLACEBO COMPARATOR

Intravenous infusion WJMSCs or placebo in patients with ischemic heart failure.

Biological: Placebo

Interventions

WJMSCs Vs. placebo BIOLOGICAL

WJMSCs Vs. placebo

Intracoronary infusion WJMSCs

Placebo BIOLOGICAL

WJMSCs Vs. placebo

Intravenous infusion WJMSCs

Eligibility Criteria

• Age: 17 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age no limited
• Patient must provide written informed consent.
• Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by any of the following 3 criteria:
• Previous MI is documented by a clinical history that includes an elevation of cardiac enzymes and/or electrocardiogram (ECG) changes consistent with MI.
• Patients treated with thrombolytic therapy or percutaneous coronary revascularization.
• Screening CMRI shows an area of akinesis, dyskinesis, or severe hypokinesis associated with evidence of myocardial scarring based on delayed hyperenhancement after gadolinium infusion.
• Patient has been treated with appropriate maximal medic al therapy for ICMP. For β -blockade, the patient must have be en on a stable dose of a clinically appropriate β-blocker for 3 months. For angiotensin-converting enzyme inhibition, the patient must have been on a stable dose of a clinically appropriate agent for 1 m
• left ventricular ejection fraction (LVEF)\<45% by echocardiogram, CMRI, or left ventriculogram within the prior 6 m
• Patients who are a candidate for cardiac catheterization assignment intracoronary infusion group; but patients in no-candidate for cardiac catheterization assignment intravenous infusion group.

You may not qualify if:

• Have a baseline glomerular filtration rate \> 50 mL/min per 1.73 m2
• Evidence of a life-threatening arrhythmia (ventricular tachycardia or complete heart block) on screening ECG..
• Have a hematologic abnormality as evidenced by hematocrit \<25% , white blood cell \<2500/u L or platelet values\<100000/u L without another explanation.
• Have liver dysfunction , as evidenced by enzymes (aspartate aminotransferase and alanine aminotransferase) \>3× the upper limits of normal.
• Have a coagulopathy (international normalized ratio \> 1.3) not because of a reversible cause (ie, coumadin).
• Have a contraindication to performance of CMRI (CMRIs will be performed in patients with pacemaker who are not pacemaker dependent).
• Be an organ transplant recipient.
• Have a clinical history of malignancy within 5 y except curatively treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
• Have a noncardiac condition that limits lifespan to \<1y.
• Have a history of drug or alcohol abuse within the past 24 m.
• Be serum positive for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C.
• Be a female who is pregnant, nursing, or of childbearing potential who is not practicing effective contraceptive methods.

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead
• First People's Hospital of Foshan: collaborator
• General Hospital of Armed Police, Beijing: collaborator
• PLA General Hospital, Beijing: collaborator

Study Officials

• Ning K Zhang, MS

  Navy General Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Yu Chen, MD,PhD

CONTACT

18600310120; yuchen911@hotmail.com

Lian Ru Gao, MD

CONTACT

13381207121; glianru668@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 23, 2015
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 5, 2019

Record last verified: 2019-12