The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Chronic Heart Failure of Non-ischemic Etiology
Last updated on July 2021Recruitment
- 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