NCT03925324

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Heart Disease
• Non-ischemic Cardiomyopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-03
• Primary completion: 2021-08-16
• Completion: 2021-08-16
• First posted: 2019-04-24
• Last updated: 2022-02-02
• Results posted: 2022-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study