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WJMSCs Anti-inflammatory Therapy in Coronary Artery Disease

NCT04551456 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-09-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Chinese PLA General Hospital

    collaborator OTHER

  • Peking University Third Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Xijing Hospital

    collaborator OTHER

  • Navy General Hospital, Beijing

    lead OTHER

Principal Investigators

  • Lian Ru Gao, MD · Navy General Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-12-30
Completion
2022-12-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04551456 on ClinicalTrials.gov