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Completed

NCT Number: NCT01739777

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

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.

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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Disease Genetic Diseases, Inborn Heart Diseases Heart Failure Laminopathies Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Universidad de los Andes

Santiago, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ucMSC

Biological

1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma

Other names: Umbilical Cord Mesenchymal Stem Cells

Controls

Other

Autologous Serum will administrated as placebo

Primary outcomes

  1. • Change in global left ventricular ejection fraction

    Time frame: 3, 6, 12 months

Secondary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Universidad de los Andes, Chile

Other

Registry information

Official study 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

Acronym: RIMECARD

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2012
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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