Clinical trial NCT01739777: Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dilated Cardiomyopathy
Keywords: Heart Failure
Coronary Heart Disease
Adult Stem Cells
Umbilical Progenitor Cells
Umbilical Cord Stem Cells Allogenic
Left Ventricular Function
Intravenous Injection
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
First posted: 2012-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: • Change in global left ventricular ejection fraction
timeFrame: 3, 6, 12 months
Secondary outcomes:
measure: • Change in functional capacity measured in O2 consumption
timeFrame: 0, 3, 6, 12 months
measure: • Occurrence of major adverse cardiac event
timeFrame: 12 months
measure: • Change in high sensitivity C-reactive protein (hs CRP)
timeFrame: 0, 3, 6, 12 months
measure: • Reduction in level of B-type natriuretic peptide (BNP)
timeFrame: 0, 3, 6, 12 months
Other outcomes:
measure: Measures of anti & pro inflammatory cytokines profile
timeFrame: 0-15-90 days
measure: Change in quality of life
timeFrame: 0-6-12 months
Locations:
city: Santiago de Chile
country: Chile
facility: Universidad de los Andes
Study officials:
affiliation: Universidad de Los Andes
name: Jorge Bartolucci, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.