Dilated Cardiomyopathy Clinical Trial
— RIMECARDOfficial title:
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
Verified date | June 2015 |
Source | Universidad Los Andes, Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | Chile: Comité de Ética Científico |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Chile | Universidad de los Andes | Santiago de Chile |
Lead Sponsor | Collaborator |
---|---|
Universidad Los Andes, Chile |
Chile,
Hare JM, Traverse JH, Henry TD, Dib N, Strumpf RK, Schulman SP, Gerstenblith G, DeMaria AN, Denktas AE, Gammon RS, Hermiller JB Jr, Reisman MA, Schaer GL, Sherman W. A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86. doi: 10.1016/j.jacc.2009.06.055. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Measures of anti & pro inflammatory cytokines profile | 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. | 0-15-90 days | No |
Other | Change in quality of life | Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ). Kansas, City Cardiomyopathy Questionnaire (KCCQ) |
0-6-12 months | No |
Primary | • Change in global left ventricular ejection fraction | 3, 6, 12 months | No | |
Secondary | • Change in functional capacity measured in O2 consumption | 0, 3, 6, 12 months | No | |
Secondary | • Occurrence of major adverse cardiac event | 12 months | Yes | |
Secondary | • Change in high sensitivity C-reactive protein (hs CRP) | 0, 3, 6, 12 months | No | |
Secondary | • Reduction in level of B-type natriuretic peptide (BNP) | 0, 3, 6, 12 months | No |
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