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

Universidad de los Andes, Chile

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dilated Cardiomyopathy

Treatments: Biological: ucMSC; Other: Controls

Study type: Interventional

Funder types: Other

Identifiers

NCT01739777

UANDES-C4C

CORFO-11IEI-9766 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

ucMSC

Experimental group

Description:

Umbilical cord derived mesenchymal are injected intravenously to Patients.

Treatment:

Biological: ucMSC

Controls

Placebo Comparator group

Description:

Intravenous placebo solution are administrated to Patients.

Treatment:

Other: Controls