Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01739777
Previous Study | Return to List | Next Study

Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy (RIMECARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01739777
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Jorge Bartolucci, Universidad de los Andes, Chile

Tracking Information
First Submitted Date  ICMJE November 29, 2012
First Posted Date  ICMJE December 3, 2012
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
• Change in global left ventricular ejection fraction [ Time Frame: 3, 6, 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
  • • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
  • • 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 quality of life [ Time Frame: 0, 3, 6, 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: January 23, 2013)
  • 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)
Original Other Pre-specified Outcome Measures
 (submitted: November 29, 2012)
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.
 
Descriptive Information
Brief Title  ICMJE Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dilated Cardiomyopathy
Intervention  ICMJE
  • Biological: ucMSC
    1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma
    Other Name: Umbilical Cord Mesenchymal Stem Cells
  • Other: Controls
    Autologous Serum will administrated as placebo
Study Arms  ICMJE
  • Experimental: ucMSC
    Umbilical cord derived mesenchymal are injected intravenously to Patients.
    Intervention: Biological: ucMSC
  • Placebo Comparator: Controls
    Intravenous placebo solution are administrated to Patients.
    Intervention: Other: Controls
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01739777
Other Study ID Numbers  ICMJE UANDES-C4C
CORFO-11IEI-9766 ( Other Identifier: Government grants )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jorge Bartolucci, Universidad de los Andes, Chile
Study Sponsor  ICMJE Universidad de los Andes, Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jorge Bartolucci, Dr. Universidad de los Andes
PRS Account Universidad de los Andes, Chile
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP