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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
Sponsor:
Information provided by (Responsible Party):
Jorge Bartolucci, Universidad de los Andes, Chile

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Biological: ucMSC Other: Controls Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : December 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. • Change in functional capacity measured in O2 consumption [ Time Frame: 0, 3, 6, 12 months ]
  2. • Occurrence of major adverse cardiac event [ Time Frame: 12 months ]
  3. • Change in high sensitivity C-reactive protein (hs CRP) [ Time Frame: 0, 3, 6, 12 months ]
  4. • Reduction in level of B-type natriuretic peptide (BNP) [ Time Frame: 0, 3, 6, 12 months ]

Other Outcome Measures:
  1. 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.

  2. 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)



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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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
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Chile
Universidad de los Andes
Santiago de Chile, Chile
Sponsors and Collaborators
Universidad de los Andes, Chile
Investigators
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Principal Investigator: Jorge Bartolucci, Dr. Universidad de los Andes
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jorge Bartolucci, Medical director of Celular Therapy, Universidad de los Andes, Chile
ClinicalTrials.gov Identifier: NCT01739777    
Other Study ID Numbers: UANDES-C4C
CORFO-11IEI-9766 ( Other Identifier: Government grants )
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by Jorge Bartolucci, Universidad de 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:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
 Cardiomegaly
Laminopathies
Genetic Diseases, Inborn