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WJMSCs Anti-inflammatory Therapy in Acute Myocardial Infarction

NCT04551443 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-09-16

No results posted yet for this study

Summary

Cumulative evidence has demonstrated that cardiac repair after acute myocardial infarction (AMI) is characterized by a series of time-dependent events orchestrated by the innate immune system. This begins immediately after the onset of necrotic cell death with intense sterile inflammation and myocardial infiltration of a variety of immune cell subtypes including monocytes and macrophages during the first several days after MI. There is increasing evidence to suggest inflammation is not limited to the infarcted myocardium and systemic imbalances in the post-infarct inflammatory cascade can exacerbate adverse remodelling beyond the infarct site. Therefore, it is very important that therapies seek to target the intricate balance between pro- and antiinflammatory pathways timely after AMI. Human mesenchymal stem cells (hMSCs) have been shown to exhibit immunomodulation, angiogenesis, and paracrine secretion of bioactive factors that can attenuate inflammation and promote tissue regeneration, making them a promising cell source for AMI therapy. However, it has been proved in our and other studies that perfusion of WJMSCs after 5 days of AMI can only slightly improve left ventricular end-diastolic volume, which is the most important indicator of left ventricular remodeling. Thus, WANIAMI Trial is a randomized, double-blind, placebo controlled, phase#study designed to assess the safety and feasibility of intravenous infusion of WJMSCs in the treatment of patients in the acute phase ( within 24h) with the both of ST-Segment-Elevation or Non-ST-Segment-Elevation AMI.

Conditions

  • Acute Myocardial Infarction

Interventions

BIOLOGICAL

Intravenous infusion placebo

Intravenous infusion placebo or WJMSCs in patients with AMI

BIOLOGICAL

Intravenous infusion WJMSCs

Intravenous infusion WJMSCs or placebo in patients with AMI

Sponsors & Collaborators

  • Peking University Third Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Xijing Hospital

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Navy General Hospital, Beijing

    lead OTHER

Principal Investigators

  • Lian Ru Gao, MD · The Sixth Medical Center of P.L.A. General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-12-30
Completion
2022-12-30

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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 NCT04551443 on ClinicalTrials.gov