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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dilated Cardiomyopathy
- Sponsor
- Universidad de los Andes, Chile
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- • Change in global left ventricular ejection fraction
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Jorge Bartolucci
Medical director of Celular Therapy
Universidad de los Andes, Chile
Eligibility Criteria
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
Outcomes
Primary Outcomes
• Change in global left ventricular ejection fraction
Time Frame: 3, 6, 12 months
Secondary Outcomes
- • 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)