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

Phase 1

Completed

• Conditions: Dilated Cardiomyopathy
• Interventions: Other: Controls; Biological: ucMSC

• Registration Number: NCT01739777
• Lead Sponsor: Universidad de los Andes, Chile

Brief 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.

Study Timeline

• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-11-29
• Study Start: 2012-12
• Study First Posted: 2012-12-03
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Symptomatic heart failure patients in dilated stages
• Etiologies: dilated cardiomyopathy, chronic hypertensive cardiopathy in dilated stage, chronic coronary cardiopathy in dilated stage
• Ejection fraction ≤ 40%.
• Patients who are stable under optimal medical treatment for a period of at least 3 months prior to randomization

Exclusion Criteria

• Severe or persistent heart failure
• Recurrent myocardial ischemia
• Uncontrolled ventricular tachycardia
• Malignant disease (life expectancy of less than one year)
• Manifest ventricular asynchrony
• Hematologic disease
• Recent cerebrovascular disease
• Recent acute coronary syndrome
• Serum creatinine >2.26 mg/dL (200 umol/L)
• Atrial fibrillation without heart rate control in the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controls	Controls	Intravenous placebo solution are administrated to Patients.
ucMSC	ucMSC	Umbilical cord derived mesenchymal are injected intravenously to Patients.

Primary Outcome Measures

Name	Time	Method
• Change in global left ventricular ejection fraction	3, 6, 12 months

Secondary Outcome Measures

Name	Time	Method
• Change in functional capacity measured in O2 consumption	0, 3, 6, 12 months
• Occurrence of major adverse cardiac event	12 months
• Change in high sensitivity C-reactive protein (hs CRP)	0, 3, 6, 12 months
• Reduction in level of B-type natriuretic peptide (BNP)	0, 3, 6, 12 months

Trial Locations

Locations (1)

Universidad de los Andes; 🇨🇱 Santiago de Chile, Chile