WJMSCs Anti-inflammatory Therapy in Acute Myocardial Infarction

NCT04551443 | Unknown Phase 2 DMC

• 1 other identifier: PLAG6C
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

AMI;; Mesenchymal Stem Cells;; anti-inflammatory;

Outcome Measures

Primary Outcomes (4)

• Any composite of major adverse cardiovascular events

  The main safety endpoints was the first occurrence of a major adverse cardiovascular event (a composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death) and hospitalization for unstable angina that led to urgent coronary revascularization within 12 months.

  12 months

• Checking patient LVEF

  The main feasibility endpoints were defined as the change in LVEF, infarct size as determined by MRI and perfusion defect as assessed by MIBI SPECT from baseline to 6 months.

  6 months

• Checking patient infarct size

  The main feasibility endpoints were defined as the change in infarct size

  6 months

• checking patient perfusion defect.

  The main feasibility endpoints were defined as non significant perfusion defect

  6 months

Secondary Outcomes (3)

• Coronary disease

  12 months

• Coronary congestive heart failure

  12 months

• Coronary changes in hsCRP

  12 months

Study Arms (2)

Placebo PBS

PLACEBO COMPARATOR

Standard therapy+Intravenous infusion PBS in patients with AMI

Biological: Intravenous infusion placebo; Biological: Intravenous infusion WJMSCs

WJMScs

ACTIVE COMPARATOR

Standard therapy+Intravenous infusion WJMSCs in patients with AMI

Biological: Intravenous infusion placebo; Biological: Intravenous infusion WJMSCs

Interventions

Intravenous infusion placebo BIOLOGICAL

Intravenous infusion placebo or WJMSCs in patients with AMI

Also known as: PBS

Placebo PBS; WJMScs

Intravenous infusion WJMSCs BIOLOGICAL

Intravenous infusion WJMSCs or placebo in patients with AMI

Also known as: WJMSCs

Placebo PBS; WJMScs

Eligibility Criteria

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

You may qualify if:

• Age limited ≥ 18 years at Visit 1
• Patient must provide written informed consent
• Have a diagnosis of acute ST-Segment-Elevation or Non-ST-Segment-Elevation myocardial infarction as defined by any of the following criteria:
• According to the Third Universal Definition of Myocardial Infarction Type:
• Type 1 spontaneous myocardial infarction Type 2 myocardial infarction secondary to an ischemic imbalance Type 3 myocardial infarction resulting in death when biomarker values are unavailable Including: acute ST-Segment-Elevation or Non-ST-Segment-Elevation myocardial infarction, creatine kinase (CK)-MB levels over three-fold the upper limit of the reference values.
• Successful or unsuccessful. revascularization by percutaneous coronary intervention, within 12 hours after symptom onset with stent implantation and thrombolysis.

You may not qualify if:

• Myocardial infarction related to stent thrombosis; Myocardial infarction related to restenosis
• Myocardial infarction related to coronary artery bypass grafting (CABG)
• 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
• Peking University Third Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Xijing Hospital: collaborator
• Chinese PLA General Hospital: collaborator

Study Officials

• Lian Ru Gao, MD

  The Sixth Medical Center of P.L.A. General Hospital

  STUDY CHAIR

Central Study Contacts

Ning K Zhang, MS

CONTACT

13011864761; zhangningkun2004@163.com

Chen Yu, 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: The eligible patients were assigned randomly to each of two groups (WJMSCs or placebo control) in a 1:1 fashion using a computer-generated randomization of sequence numbers. 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: Placebo Comparator: Intravenous infusion WJMSCs +standard therapy Vs placebo+ standard therapy in patients with acute myocardial infarction

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: September 16, 2020
• Study Start: November 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: September 16, 2020

Record last verified: 2019-12