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

NCT ID: NCT02368587

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-07-31

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.

Detailed Description

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.

Conditions

Ischemic Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intracoronary infusion WJMSCs

Intracoronary infusion WJMSCs or placebo in patients with ischemic heart failure

Group Type: PLACEBO_COMPARATOR

WJMSCs Vs. placebo

Intervention Type: BIOLOGICAL

WJMSCs Vs. placebo

Intravenous infusion WJMSCs

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

WJMSCs Vs. placebo

Interventions

WJMSCs Vs. placebo

WJMSCs Vs. placebo

Intervention Type: BIOLOGICAL

Placebo

WJMSCs Vs. placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Age no limited

2. Patient must provide written informed consent.

3. 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.

4. 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

5. left ventricular ejection fraction (LVEF)<45% by echocardiogram, CMRI, or left ventriculogram within the prior 6 m

6. Patients who are a candidate for cardiac catheterization assignment intracoronary infusion group; but patients in no-candidate for cardiac catheterization assignment intravenous infusion group.

Exclusion Criteria

1. Have a baseline glomerular filtration rate > 50 mL/min per 1.73 m2

2. Evidence of a life-threatening arrhythmia (ventricular tachycardia or complete heart block) on screening ECG..

3. Have a hematologic abnormality as evidenced by hematocrit <25% , white blood cell <2500/u L or platelet values<100000/u L without another explanation.

4. Have liver dysfunction , as evidenced by enzymes (aspartate aminotransferase and alanine aminotransferase) >3× the upper limits of normal.

5. Have a coagulopathy (international normalized ratio > 1.3) not because of a reversible cause (ie, coumadin).

6. Have a contraindication to performance of CMRI (CMRIs will be performed in patients with pacemaker who are not pacemaker dependent).

7. Be an organ transplant recipient.

8. Have a clinical history of malignancy within 5 y except curatively treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.

9. Have a noncardiac condition that limits lifespan to <1y.

10. Have a history of drug or alcohol abuse within the past 24 m.

11. Be serum positive for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C.

12. Be a female who is pregnant, nursing, or of childbearing potential who is not practicing effective contraceptive methods.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Foshan

OTHER

Sponsor Role: collaborator

General Hospital of Armed Police, Beijing

UNKNOWN

Sponsor Role: collaborator

PLA General Hospital, Beijing

UNKNOWN

Sponsor Role: collaborator

Navy General Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ning K Zhang, MS

Role: STUDY_DIRECTOR

Navy General Hospital, Beijing

Central Contacts

Yu Chen, MD,PhD

Role: CONTACT

yuchen911@hotmail.com

18600310120

Lian Ru Gao, MD

Role: CONTACT

glianru668@126.com

13381207121

Other Identifiers

NavyGHB

Identifier Type: -

Identifier Source: org_study_id