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Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device

NCT03925324 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-02-02

Study results available
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Summary

A study to assess the safety and preliminary efficacy of serial intravenous dose of Allogeneic Mesenchymal Bone Marrow Cells in subjects with heart failure and implanted left ventricular assist devices.

Conditions

  • Ischemic Heart Disease
  • Non-ischemic Cardiomyopathy

Interventions

BIOLOGICAL

Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)

Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg

OTHER

Placebo

1.5 mL/kg Lactated Ringer's Solution

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-03
Primary Completion
2021-08-16
Completion
2021-08-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03925324 on ClinicalTrials.gov