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

Dilated Cardiomyopathy Clinical Trial

— RIMECARD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739777
• Other study ID #: UANDES-C4C
• Secondary ID: CORFO-11IEI-9766
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 29, 2012
• Last updated: June 2, 2015
• Start date: December 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Universidad Los Andes, Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética Científico
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Biological:
• ucMSC
1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma

Other:
• Controls
Autologous Serum will administrated as placebo

Locations

Country	Name	City	State
Chile	Universidad de los Andes	Santiago de Chile

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Los Andes, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Hare JM, Traverse JH, Henry TD, Dib N, Strumpf RK, Schulman SP, Gerstenblith G, DeMaria AN, Denktas AE, Gammon RS, Hermiller JB Jr, Reisman MA, Schaer GL, Sherman W. A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86. doi: 10.1016/j.jacc.2009.06.055. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measures of anti & pro inflammatory cytokines profile	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.	0-15-90 days	No
Other	Change in quality of life	Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ). Kansas, City Cardiomyopathy Questionnaire (KCCQ)	0-6-12 months	No
Primary	• Change in global left ventricular ejection fraction		3, 6, 12 months	No
Secondary	• Change in functional capacity measured in O2 consumption		0, 3, 6, 12 months	No
Secondary	• Occurrence of major adverse cardiac event		12 months	Yes
Secondary	• Change in high sensitivity C-reactive protein (hs CRP)		0, 3, 6, 12 months	No
Secondary	• Reduction in level of B-type natriuretic peptide (BNP)		0, 3, 6, 12 months	No

External Links

•   Universidad de los Andes.