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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dilated Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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ucMSC

Umbilical cord derived mesenchymal are injected intravenously to Patients.

Group Type EXPERIMENTAL

ucMSC

Intervention Type BIOLOGICAL

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

Controls

Intravenous placebo solution are administrated to Patients.

Group Type PLACEBO_COMPARATOR

Controls

Intervention Type OTHER

Autologous Serum will administrated as placebo

Interventions

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ucMSC

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

Intervention Type BIOLOGICAL

Controls

Autologous Serum will administrated as placebo

Intervention Type OTHER

Other Intervention Names

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Umbilical Cord Mesenchymal Stem Cells

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No