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

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Brief Title

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

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

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 Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

• Change in global left ventricular ejection fraction

Secondary Outcome

 • Change in functional capacity measured in O2 consumption

Condition

Dilated Cardiomyopathy

Intervention

ucMSC

Study Arms / Comparison Groups

 ucMSC
Description:  Umbilical cord derived mesenchymal are injected intravenously to Patients.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

30

Start Date

December 2012

Completion Date

June 2015

Primary Completion Date

June 2015

Eligibility 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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Jorge Bartolucci, Dr., , 

Location Countries

Chile

Location Countries

Chile

Administrative Informations


NCT ID

NCT01739777

Organization ID

UANDES-C4C

Secondary IDs

CORFO-11IEI-9766

Responsible Party

Principal Investigator

Study Sponsor

Universidad de los Andes, Chile


Study Sponsor

Jorge Bartolucci, Dr., Principal Investigator, Universidad de los Andes


Verification Date

June 2015