A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of the Safety and Efficacy of Intravenous Delivery of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients and Implanted Left Ventricular Assist Device

Medstar Health Research Institute1 site in 1 country4 target enrollmentMay 3, 2019

ConditionsIschemic Heart Disease Non-ischemic Cardiomyopathy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ischemic Heart Disease
Sponsor: Medstar Health Research Institute
Enrollment: 4
Locations: 1
Primary Endpoint: Uncontrolled Systemic Infection
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

A double-blind, placebo-controlled, single-center, randomized study to assess the safety and preliminary efficacy of a three serial intravenous doses of allogeneic mesenchymal bone marrow cells to subjects with heart failure and implanted left ventricular assist devices.

Registry

clinicaltrials.gov

Start Date

May 3, 2019

End Date

August 16, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medstar Health Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years.
•Advanced Heart Failure
•Advanced HF defined as HF requiring LVAD implantation and deemed stable on his/her LVAD.
•On stable medical therapy (per the discretion of the treating physician) including beta-blockers, ACE-inhibitors, angiotensin receptors blockers, angiotensin receptor neprilysin inhibitor, mineralocorticoid receptor antagonists, isosorbide, hydralazine, and mineralocorticoid receptor antagonists) and optimized pump speed for at least a month prior to randomization.
•HS-CRP level≥2 mg/l.
•NYHA class II-III symptoms.
•Ability to understand and provide signed informed consent.
•Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits

Exclusion Criteria

•Women of childbearing potential. Postmenopausal women or women with permanent contraception method (defined as total hysterectomy) will not be excluded.
•History of debilitating stroke (modified Rankin Score \> 3) within 3 months.
•The likelihood of requirement of cardiac surgery during the study period.
•Presence of clinically significant, uncorrected left sided valvular heart disease, active acute myocarditis, or uncontrolled hypertension defined as Persistently elevated mean arterial blood pressure (\>100 mmHg). Echocardiography within 12 months of screening. Patients can be re-evaluated, at the discretion of the investigator.
•QTc \>550 ms (in the absence of bundle branch block, interventricular conduction delay or ventricular pacing). Electrocardiogram (ECG) within 60 days.
•History of cardiac arrest within 3 months.
•Hypertrophic or infiltrative cardiomyopathy.
•Considered or listed for organ transplantation or history of organ transplantation
•Illness other than HF with life expectancy less than 12 months.
•Enrolled in an interventional trial or received an experimental drug or device within 30 days of randomization.

Outcomes

Primary Outcomes

Uncontrolled Systemic Infection

Time Frame: up to 12 months post enrollment

Number of admission for uncontrolled systemic infection

Temperature

Time Frame: up to 12 months post enrollment

Temperature

All-cause Mortality

Time Frame: up to 12 months post enrollment

Rate of Death

Secondary Outcomes

6 Minute Walk Distance Changes(Baseline and day 90 post initial infusion)
Change in RV Systolic Function(Baseline and day 90 post initial infusion)
Hospitalizations Due to Right Heart Failure(day 90)
Gout Flares(Day 90)
Change in the Following Cardiac Biomarker(Baseline and day 90 post initial infusion)
NK Cell Depletion(Baseline to day 90)