Dilated Cardiomyopathy
Conditions
Keywords
Heart Failure, Coronary Heart Disease, Adult Stem Cells, Umbilical Progenitor Cells, Umbilical Cord Stem Cells Allogenic, Left Ventricular Function, Intravenous Injection
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.
Interventions
BIOLOGICALucMSC
1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma
OTHERControls
Autologous Serum will administrated as placebo
Sponsors
Universidad de los Andes, Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Change in global left ventricular ejection fraction | 3, 6, 12 months |
Secondary
| Measure | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measures of anti & pro inflammatory cytokines profile | 0-15-90 days | The cytokine profile we can determinate is Interleukin 1 Beta(IL-1b),Interleukin 6 (IL-6), soluble receptor TNF (TNFRs), tumor necrosis factor(TNF), Interleukin 10 (IL-10), Transforming Growth Factor beta (TGFb), Interferon-gamma (IFNg),Interleukin 17A (IL-17A),Interleukin-4(IL-4) by multiflex flow cytometer. |
| Change in quality of life | 0-6-12 months | Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ). Kansas, City Cardiomyopathy Questionnaire (KCCQ) |
Countries
Chile
Outcome results
None listed