We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01739777
First Posted: December 3, 2012
Last Update Posted: June 4, 2015
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.
Information provided by (Responsible Party):
Jorge Bartolucci, Universidad Los Andes, Chile
  Purpose
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.

Condition Intervention Phase
Dilated Cardiomyopathy Biological: ucMSC Other: Controls Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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

Resource links provided by NLM:


Further study details as provided by Jorge Bartolucci, Universidad Los Andes, Chile:

Primary Outcome Measures:
  • • Change in global left ventricular ejection fraction [ Time Frame: 3, 6, 12 months ]

Secondary Outcome Measures:
  • • 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 ]

Other Outcome Measures:
  • 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)



Enrollment: 30
Study Start Date: December 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ucMSC
Umbilical cord derived mesenchymal are injected intravenously to Patients.
Biological: ucMSC
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.
Other: Controls
Autologous Serum will administrated as placebo

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Chile
Universidad de los Andes
Santiago de Chile, Chile
Sponsors and Collaborators
Universidad Los Andes, Chile
Investigators
Principal Investigator: Jorge Bartolucci, Dr. Universidad de los Andes
  More Information

Additional Information:
Publications:
Responsible Party: Jorge Bartolucci, Medical director of Celular Therapy, Universidad Los Andes, Chile
ClinicalTrials.gov Identifier: NCT01739777     History of Changes
Other Study ID Numbers: UANDES-C4C
CORFO-11IEI-9766 ( Other Identifier: Government grants )
First Submitted: November 29, 2012
First Posted: December 3, 2012
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Jorge Bartolucci, Universidad Los Andes, Chile:
Heart Failure
Coronary Heart Disease
Adult Stem Cells
Umbilical Progenitor Cells
Umbilical Cord Stem Cells Allogenic
Left Ventricular Function
Intravenous Injection

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly