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