Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Heart Failure
  • Non Ischemic Cardiomyopathy
  • Non-ischemic Dilated Cardiomyopathy
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The purpose of this study is to optimize the complex treatment of non-ischemic dilated cardiomyopathy by supplementing the standard drug therapy with intracoronary administration of umbilical cord-derived mesenchymal stromal cells. Sixty patients will be selected and randomly divided into the main a...

The purpose of this study is to optimize the complex treatment of non-ischemic dilated cardiomyopathy by supplementing the standard drug therapy with intracoronary administration of umbilical cord-derived mesenchymal stromal cells. Sixty patients will be selected and randomly divided into the main and control groups in a 1: 1 ratio. Patients of the main group will receive complex treatment based on the addition to the standard drug therapy of intracoronary administration of 10 million mesenchymal stromal cells of the umbilical cord, and patients of the control group will receive only standard drug therapy. Every patient will maintain their standard treatment of chronic heart failure, with maximum tolerated dosage without side effects. The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3 and 3-6 months. Clinical results will be analyzed after completion of 6 months of followup.

Tracking Information

NCT #
NCT04325594
Collaborators
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Investigators
Principal Investigator: Aziz Azkhojayev, MD The Research-Clinical Center for Cardiac Surgery and Transplantology LLP