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WJMSCs Anti-inflammatory Therapy in Coronary Artery Disease (WANICHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551456
Recruitment Status : Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Chinese PLA General Hospital
Peking University Third Hospital
Peking Union Medical College Hospital
Xijing Hospital
Information provided by (Responsible Party):
Navy General Hospital, Beijing

Brief Summary:
As biologic, epidemiologic, and clinical trial data have demonstrated, inflammation is a key driver of atherosclerosis. Recently, a gigantic proof-of-concept trial, CANTOS has demonstrated that inflammation of atherosclerosis can be effectively modulated by Canakinumab. However, fatal infections encountered and high cost in CANTOS. There is, therefore, a clear need for cheaper and safe alternatives. The latest cell biological studies have demonstrated that mesenchymal stem cells have a unique immunomodulatory function. MSCs contribute to a critical role in regulating the inflammatory microenvironment and interacting with immune cells and induce anti- inflammatory macrophages, inhibit foam cell formation, which could reduce atherosclerosis in pre-clinical studies. Therefore, in this randomized, controlled trial, our aim was to assess the safety and the anti-inflammatory efficacy of intravenous infusion human umbilical Wharton's jelly-derived mesenchymal stem Cell (WJMSC) in patients with coronary artery atherosclerosis disease.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Biological: Intravenous infusion human umbilical Wharton's jelly-derived mesenchymal stem Cell or placebo PBS Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment Arms Placebo Comparator: WANICAD Trial are as a 3 arm trial comparing standard of care plus placebo to either standard of care plus WJMSC one or three times infusion with participants allocated to each study arm in a 1:1:1 ratio
Masking: Double (Participant, Investigator)
Masking Description: Physicians and other clinical personnel remained blind to the treatment assignment throughout the study.
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled, Intravenous Infusion Human Wharton' Jelly-derived Mesenchymal Stem Cells in Patients With Coronary Artery Disease
Estimated Study Start Date : November 30, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Infusion PBS

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

Biological: Intravenous infusion human umbilical Wharton's jelly-derived mesenchymal stem Cell or placebo PBS
Randomised, Double-blind, Placebo-controlled, Intravenous Infusion HumanWharton' Jelly-derived Mesenchymal Stem Cells in Patients With Coronary Artery Disease
Other Name: Intravenous infusion WJMSCs or placebo

Experimental: Single dose Infusion WJMSCs

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

Biological: Intravenous infusion human umbilical Wharton's jelly-derived mesenchymal stem Cell or placebo PBS
Randomised, Double-blind, Placebo-controlled, Intravenous Infusion HumanWharton' Jelly-derived Mesenchymal Stem Cells in Patients With Coronary Artery Disease
Other Name: Intravenous infusion WJMSCs or placebo

Experimental: Infusion WJMSCs multiple doses

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

Biological: Intravenous infusion human umbilical Wharton's jelly-derived mesenchymal stem Cell or placebo PBS
Randomised, Double-blind, Placebo-controlled, Intravenous Infusion HumanWharton' Jelly-derived Mesenchymal Stem Cells in Patients With Coronary Artery Disease
Other Name: Intravenous infusion WJMSCs or placebo




Primary Outcome Measures :
  1. The primary end point was checking incidence of adverse events (AEs) within 12 months, [ Time Frame: up to 12 months ]
    Including death from any cause; a composite of major adverse cardiovascular events of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death and hospitalization for unstable angina that led to urgent coronary revascularization;


Secondary Outcome Measures :
  1. The secondary end point was measuring low attenuation plaque volume LAPV [ Time Frame: up to 10 months ]
    The secondary end point was efficacy, which was assessed in terms of the change in low attenuation plaque volume LAPV by Coronary computed tomography angiography (coronary CTA) from baseline to 12 months.

  2. The secondary end point was efficacy 2 [ Time Frame: up to 10 months ]
    The level of high-sensitivity C-reactive protein (hsCRP) from baseline to 12 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years at Visit 1;
  2. Patient must provide written informed consent;
  3. Have a diagnosis of coronary artery atherosclerotic disease as defined by any of the following 3 criteria:

    1. 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.
    2. All patients underwent invasive coronary angiography at the time of presentation and were revascularized if clinically indicated, or these patients underwent coronary CTA
    3. Multivessel coronary disease confirmed by coronary angiography or CTA

Exclusion Criteria:

  1. Evidence of a life-threatening arrhythmia (ventricular tachycardia or complete heart block) on screening ECG..
  2. Have a hematologic abnormality as evidenced by hematocrit <25% , white blood cell <2500/u L or platelet values<100000/u L without another explanation.
  3. Have liver dysfunction, as evidenced by enzymes (aspartate aminotransferase and alanine aminotransferase) >3× the upper limits of normal.
  4. Have a coagulopathy (international normalized ratio>1.3) not because of a reversible cause (ie, coumadin).
  5. Be an organ transplant recipient.
  6. Have a clinical history of malignancy within 5 y except curatively treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
  7. Have a noncardiac condition that limits lifespan to <1y.
  8. Have a history of drug or alcohol abuse within the past 24 m.
  9. Be serum positive for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C.
  10. Be a female who is pregnant, nursing, or of childbearing potential who is not practicing effective contraceptive methods.-

Information from the National Library of Medicine

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): NCT04551456


Contacts
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Contact: Ning Kun Zhang, MS 13011864761 zhangningkun2004@163.com
Contact: Yu chen, MD.PhD 18600310120 yuchen911@hotmail.com

Sponsors and Collaborators
Navy General Hospital, Beijing
Chinese PLA General Hospital
Peking University Third Hospital
Peking Union Medical College Hospital
Xijing Hospital
Investigators
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Study Chair: Lian Ru Gao, MD Navy General Hospital, Beijing
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Responsible Party: Navy General Hospital, Beijing
ClinicalTrials.gov Identifier: NCT04551456    
Other Study ID Numbers: NavyGHB-007
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Navy General Hospital, Beijing:
coronary artery disease
anti-inflammatory therapy
human umbilical cord Wharton's jelly-derived MSCs (WJMSCs)
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases