WJMSCs Anti-inflammatory Therapy in Coronary Artery Disease

NCT04551456 | Unknown Phase 2 DMC

• 1 other identifier: NavyGHB-007
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; anti-inflammatory therapy; human umbilical cord Wharton's jelly-derived MSCs (WJMSCs)

Outcome Measures

Primary Outcomes (1)

• The primary end point was checking incidence of adverse events (AEs) within 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;

  up to 12 months

Secondary Outcomes (2)

• The secondary end point was measuring low attenuation plaque volume LAPV

  up to 10 months

• The secondary end point was efficacy 2

  up to 10 months

Study Arms (3)

Placebo Infusion PBS

PLACEBO COMPARATOR

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

Single dose Infusion WJMSCs

EXPERIMENTAL

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

Infusion WJMSCs multiple doses

EXPERIMENTAL

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

Interventions

Intravenous infusion human umbilical Wharton's jelly-derived mesenchymal stem Cell or placebo PBS BIOLOGICAL

Randomised, Double-blind, Placebo-controlled, Intravenous Infusion HumanWharton' Jelly-derived Mesenchymal Stem Cells in Patients With Coronary Artery Disease

Also known as: Intravenous infusion WJMSCs or placebo

Infusion WJMSCs multiple doses; Placebo Infusion PBS; Single dose Infusion WJMSCs

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.-

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead
• Chinese PLA General Hospital: collaborator
• Peking University Third Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Xijing Hospital: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lian Ru Gao, MD

  Navy General Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

Ning Kun Zhang, MS

CONTACT

13011864761; zhangningkun2004@163.com

Yu chen, MD.PhD

CONTACT

18600310120; yuchen911@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Physicians and other clinical personnel remained blind to the treatment assignment throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: September 16, 2020
• Study Start: November 30, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: September 16, 2020

Record last verified: 2019-12