WJMSCs Anti-inflammatory Therapy in Coronary Artery Disease (WANICHD)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, anti-inflammatory therapy, human umbilical cord Wharton's jelly-derived MSCs (WJMSCs)
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years at Visit 1;
- Patient must provide written informed consent;
Have a diagnosis of coronary artery atherosclerotic disease as defined by any of the following 3 criteria:
- Previous MI is documented by a clinical history or documented either by hospital records or by evidence that includes an elevation of cardiac enzymes and/or electrocardiogram (ECG) changes consistent with MI.
- All patients underwent invasive coronary angiography at the time of presentation and were revascularized if clinically indicated, or these patients underwent coronary CTA
- Multivessel coronary disease confirmed by coronary angiography or CTA
Exclusion Criteria:
- 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).
- 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.-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo Infusion PBS
Single dose Infusion WJMSCs
Infusion WJMSCs multiple doses
The investigators performed a double-blind, placebocontrolled trial, randomly assigning 100 patients with coronary artery disease to have standard of care plus placebo. Participants allocated to each study arm in a 1:1:1 ratio, to investigate the therapeutic efficacy and safety of WJMSCs in patients with coronary artery disease. Assigned Interventions: Biological/Vaccine: Biological/Vaccine: WJMSCs Vs.placebo
The investigators performed a double-blind, placebocontrolled trial, randomly assigning 100 patients with coronary artery disease to compare standard of care plus placebo to standard of care plus one time or three times in doses of 1x106 /kg of WJMSCs. Participants allocated to each study arm in a 1:1:1 ratio, to investigate the therapeutic efficacy and safety of WJMSCs in patients with coronary artery disease. Biological/Vaccine: WJMSCs Vs.placebo
The investigators performed a double-blind, placebocontrolled trial, randomly assigning 100 patients with coronary artery disease to compare standard of care plus placebo to one time or three times at 30-day intervals for equal doses of 1x106 /kg of WJMSCs. Participants allocated to each study arm in a 1:1:1 ratio, to investigate the therapeutic efficacy and safety of WJMSCs in patients with coronary artery disease. Biological/Vaccine: WJMSCs Vs.placebo