The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure
NCT04325594 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-04-20
Summary
The purpose of this prospective single-arm clinical study was to evaluate the safety and potential efficacy of intracoronary administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSCs) as an addition to standard medical therapy in patients with chronic non-ischemic heart failure.
Conditions
- Chronic Heart Failure
- Non-ischemic Cardiomyopathy
- Non-ischemic Dilated Cardiomyopathy
Interventions
- BIOLOGICAL
-
Intracoronary administration of umbilical cord-derived MSCs
A suspension of 1×10⁷ umbilical cord-derived mesenchymal stromal cells in 20 ml of heparinized saline was administered by intracoronary infusion into the left coronary artery via a standard 6 Fr catheter over 10 minutes (2 ml/min). The infusion was performed without balloon occlusion or interruption of coronary blood flow.
Sponsors & Collaborators
-
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
collaborator OTHER -
The Research-Clinical Center for Cardiac Surgery and Transplantology LLP
lead OTHER
Principal Investigators
-
Aziz Azkhojayev, MD · The Research-Clinical Center for Cardiac Surgery and Transplantology LLP
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-01
- Primary Completion
- 2023-01-01
- Completion
- 2023-04-01
Countries
- Kazakhstan
Study Locations
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