Dilated Cardiomyopathy Clinical Trial
Official title:
Phase 1 Randomized-Double Blind Clinical Trial of Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells Transplantation in Heart Failure on Patients With Cardiopathy in Dilated Stage, of Different Etiology
The purpose of this study is to determine the safety and clinical effectiveness of umbilical cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.
Phase I-II Clinical Trial - Safety and efficacy of umbilical cord derived mesenchymal stem
cells (ucMSC) in patients with heart failure Randomized, double blind, controlled
prospective study in patients with compensated heart failure in dilated phase.
Thirty patients will be selected, who will undergo a strict 3-month followup of ventricular
function before being sequentially randomized into two groups: the first group of 15
patients will receive a sole injection of ucMSC and the remaining 15 patients will comprise
the control group.
Every patient will maintain their standard treatment of 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 0-3, 3-6, and 6-12 months.
Clinical results will be analyzed after completion of 12 months of followup.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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