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| ID | Type | Description | Link |
|---|---|---|---|
| CORFO-11IEI-9766 | Other Identifier | Government grants |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ucMSC | Experimental | Umbilical cord derived mesenchymal are injected intravenously to Patients. |
|
| Controls | Placebo Comparator | Intravenous placebo solution are administrated to Patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ucMSC | Biological | 1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Change in global left ventricular ejection fraction | 3, 6, 12 months |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Bartolucci, Dr. | Universidad de Los Andes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de los Andes | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19958962 | Background | 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. | |
| 28974553 |
| Label | URL |
|---|---|
| Universidad de los Andes. | View source |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D006333 | Heart Failure |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| Controls | Other | Autologous Serum will administrated as placebo |
|
| 0, 3, 6, 12 months |
| • Reduction in level of B-type natriuretic peptide (BNP) | 0, 3, 6, 12 months |
| 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 |
| Derived |
| Bartolucci J, Verdugo FJ, Gonzalez PL, Larrea RE, Abarzua E, Goset C, Rojo P, Palma I, Lamich R, Pedreros PA, Valdivia G, Lopez VM, Nazzal C, Alcayaga-Miranda F, Cuenca J, Brobeck MJ, Patel AN, Figueroa FE, Khoury M. Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]). Circ Res. 2017 Oct 27;121(10):1192-1204. doi: 10.1161/CIRCRESAHA.117.310712. Epub 2017 Sep 26. |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |