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A Study to Assess the Effect of Intravenous Dose of (aMBMC) to Subjects With Non-ischemic Heart Failure

NCT02467387 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-01-07

Study results available
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Summary

A phase IIa study to assess the safety and preliminary efficacy of intravenous dose of ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells in subjects with non-ischemic heart failure.

Conditions

  • Non-Ischemic Heart Failure

Interventions

DRUG

Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)

One time infusion Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg.

DRUG

Lactated Ringer's Solution

One time infusion 1.5mL/kg

Sponsors & Collaborators

  • Stemedica Cell Technologies, Inc.

    collaborator INDUSTRY

  • CardioCell LLC

    lead INDUSTRY

Principal Investigators

  • Kristrun Stardal, RN, BSN · Clinical Operations Manager

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-01
Primary Completion
2017-05-11
Completion
2017-05-11

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 NCT02467387 on ClinicalTrials.gov