Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy (RIMECARD)
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|ClinicalTrials.gov Identifier: NCT01739777|
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : June 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dilated Cardiomyopathy||Biological: ucMSC Other: Controls||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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 Start Date :||December 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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
- • Change in global left ventricular ejection fraction [ Time Frame: 3, 6, 12 months ]
- • Change in functional capacity measured in O2 consumption [ Time Frame: 0, 3, 6, 12 months ]
- • Occurrence of major adverse cardiac event [ Time Frame: 12 months ]
- • Change in high sensitivity C-reactive protein (hs CRP) [ Time Frame: 0, 3, 6, 12 months ]
- • Reduction in level of B-type natriuretic peptide (BNP) [ Time Frame: 0, 3, 6, 12 months ]
- Measures of anti & pro inflammatory cytokines profile [ Time Frame: 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 [ Time Frame: 0-6-12 months ]
Measures by specific questionnaire of quality of life:
Minnesota Living with Heart Failure Questionnaire (MLHFQ). Kansas, City Cardiomyopathy Questionnaire (KCCQ)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739777
|Universidad de los Andes|
|Santiago de Chile, Chile|
|Principal Investigator:||Jorge Bartolucci, Dr.||Universidad de los Andes|