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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Universidad Los Andes, Chile
Sponsor:
Information provided by (Responsible Party):
Jorge Bartolucci, Universidad Los Andes
ClinicalTrials.gov Identifier:
NCT01739777
First received: November 29, 2012
Last updated: April 9, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Universidad Los Andes, Chile:

Primary Outcome Measures:
  • • Change in global left ventricular ejection fraction [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Change in functional capacity measured in O2 consumption [ Time Frame: 0, 3, 6, 12 months ] [ Designated as safety issue: No ]
  • • Occurrence of major adverse cardiac event [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • • Change in high sensitivity C-reactive protein (hs CRP) [ Time Frame: 0, 3, 6, 12 months ] [ Designated as safety issue: No ]
  • • Reduction in level of B-type natriuretic peptide (BNP) [ Time Frame: 0, 3, 6, 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Measures of anti & pro inflammatory cytokines profile [ Time Frame: 0-15-90 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    Measures by specific questionnaire of quality of life:

    Minnesota Living with Heart Failure Questionnaire (MLHFQ). Kansas, City Cardiomyopathy Questionnaire (KCCQ)



Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739777

Contacts
Contact: Jorge G Bartolucci, Dr. 56-2-2913 29 58 jbartolucci@gmail.com
Contact: Fernando J Verdugo, Dr. 56-2-22421219 fjverdugo@miuandes.cl

Locations
Chile
Universidad de los Andes Recruiting
Santiago de Chile, Chile
Contact: JORGE BARTOLUCCI, MD    56-2-29132958    jbartolucci@gmail.com   
Contact: FERNANDO J VERDUGO, MD    56-2-2421219    fjverdugo@miuandes.cl   
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
ClinicalTrials.gov Identifier: NCT01739777     History of Changes
Other Study ID Numbers: UANDES-C4C, CORFO-11IEI-9766
Study First Received: November 29, 2012
Last Updated: April 9, 2014
Health Authority: Chile: Comité de Ética Científico

Keywords provided by 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

ClinicalTrials.gov processed this record on October 20, 2014