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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Universidad de los Andes
Santiago, Chile
• Change in global left ventricular ejection fraction
Time frame: 3, 6, 12 months
• Change in functional capacity measured in O2 consumption
Time frame: 0, 3, 6, 12 months
• Occurrence of major adverse cardiac event
Time frame: 12 months
• Change in high sensitivity C-reactive protein (hs CRP)
Time frame: 0, 3, 6, 12 months
• Reduction in level of B-type natriuretic peptide (BNP)
Time frame: 0, 3, 6, 12 months
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