Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy (RIMECARD)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- • Change in global left ventricular ejection fraction [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
- • Change in functional capacity measured in O2 consumption [ Time Frame: 0, 3, 6, 12 months ] [ Designated as safety issue: No ]
- • Occurrence of major adverse cardiac event [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- • Change in high sensitivity C-reactive protein (hs CRP) [ Time Frame: 0, 3, 6, 12 months ] [ Designated as safety issue: No ]
- • Reduction in level of B-type natriuretic peptide (BNP) [ Time Frame: 0, 3, 6, 12 months ] [ Designated as safety issue: No ]
- Measures of anti & pro inflammatory cytokines profile [ Time Frame: 0-15-90 days ] [ Designated as safety issue: No ]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 [ Time Frame: 0-6-12 months ] [ Designated as safety issue: No ]
Measures by specific questionnaire of quality of life:
Minnesota Living with Heart Failure Questionnaire (MLHFQ). Kansas, City Cardiomyopathy Questionnaire (KCCQ)
|Study Start Date:||December 2012|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Umbilical cord derived mesenchymal are injected intravenously to Patients.
1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma
Other Name: Umbilical Cord Mesenchymal Stem Cells
Placebo Comparator: Controls
Intravenous placebo solution are administrated to Patients.
Autologous Serum will administrated as placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739777
|Universidad de los Andes|
|Santiago de Chile, Chile|
|Principal Investigator:||Jorge Bartolucci, Dr.||Universidad de los Andes|