NCT01739777

Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universidad de los Andes, Chile · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dilated Cardiomyopathy

Interventions

Type	Name	Description
BIOLOGICAL	ucMSC	1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma
OTHER	Controls	Autologous Serum will administrated as placebo

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-12-03
• Last updated: 2015-06-04

Locations

1 site across 1 country: Chile