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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dilated Cardiomyopathy

Intervention / Treatment
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* Biological: ucMSC
* Other: Controls


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ucMSC<br>Umbilical cord derived mesenchymal are injected intravenously to Patients. | Biological: ucMSC<br>* 1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma<br>* Other names: Umbilical Cord Mesenchymal Stem Cells;|
| Placebo Comparator: Controls<br>Intravenous placebo solution are administrated to Patients. | Other: Controls<br>* Autologous Serum will administrated as placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Change in global left ventricular ejection fraction |  | 3, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Coronary Heart Disease, Adult Stem Cells, Umbilical Progenitor Cells, Umbilical Cord Stem Cells Allogenic, Left Ventricular Function, Intravenous Injection