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

Primary Purpose

Dilated Cardiomyopathy

Status

Completed

Phase

Phase 1

Locations

Chile

Study Type

Interventional

Intervention

ucMSC

Controls

About this trial

This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring Heart Failure, Coronary Heart Disease, Adult Stem Cells, Umbilical Progenitor Cells, Umbilical Cord Stem Cells Allogenic, Left Ventricular Function, Intravenous Injection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Universidad de los Andes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ucMSC

Controls

Arm Description

Umbilical cord derived mesenchymal are injected intravenously to Patients.

Intravenous placebo solution are administrated to Patients.

Outcomes

Primary Outcome Measures

• Change in global left ventricular ejection fraction

Secondary Outcome Measures

• Change in functional capacity measured in O2 consumption

• Occurrence of major adverse cardiac event

• Change in high sensitivity C-reactive protein (hs CRP)

• Reduction in level of B-type natriuretic peptide (BNP)

Full Information

NCT ID

NCT01739777

First Posted

November 29, 2012

Last Updated

June 2, 2015

Sponsor

Universidad de los Andes, Chile

1. Study Identification

Unique Protocol Identification Number

NCT01739777

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de los Andes, Chile

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dilated Cardiomyopathy

Keywords

Heart Failure, Coronary Heart Disease, Adult Stem Cells, Umbilical Progenitor Cells, Umbilical Cord Stem Cells Allogenic, Left Ventricular Function, Intravenous Injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ucMSC

Arm Type

Experimental

Arm Description

Umbilical cord derived mesenchymal are injected intravenously to Patients.

Arm Title

Controls

Arm Type

Placebo Comparator

Arm Description

Intravenous placebo solution are administrated to Patients.

Intervention Type

Biological

Intervention Name(s)

ucMSC

Other Intervention Name(s)

Umbilical Cord Mesenchymal Stem Cells

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Controls

Intervention Description

Autologous Serum will administrated as placebo

Primary Outcome Measure Information:

Title

• Change in global left ventricular ejection fraction

Time Frame

3, 6, 12 months

Secondary Outcome Measure Information:

Title

• Change in functional capacity measured in O2 consumption

Time Frame

0, 3, 6, 12 months

Title

• Occurrence of major adverse cardiac event

Time Frame

12 months

Title

• Change in high sensitivity C-reactive protein (hs CRP)

Time Frame

0, 3, 6, 12 months

Title

• Reduction in level of B-type natriuretic peptide (BNP)

Time Frame

0, 3, 6, 12 months

Other Pre-specified Outcome Measures:

Title

Measures of anti & pro inflammatory cytokines profile

Description

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.

Time Frame

0-15-90 days

Title

Change in quality of life

Description

Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ). Kansas, City Cardiomyopathy Questionnaire (KCCQ)

Time Frame

0-6-12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Bartolucci, Dr.

Organizational Affiliation

Universidad de Los Andes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universidad de los Andes

City

Santiago de Chile

Country

Chile

12. IPD Sharing Statement

Citations:

PubMed Identifier

19958962

Citation

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.

Results Reference

background

PubMed Identifier

28974553

Citation

Bartolucci J, Verdugo FJ, Gonzalez PL, Larrea RE, Abarzua E, Goset C, Rojo P, Palma I, Lamich R, Pedreros PA, Valdivia G, Lopez VM, Nazzal C, Alcayaga-Miranda F, Cuenca J, Brobeck MJ, Patel AN, Figueroa FE, Khoury M. Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]). Circ Res. 2017 Oct 27;121(10):1192-1204. doi: 10.1161/CIRCRESAHA.117.310712. Epub 2017 Sep 26.

Results Reference

derived

Links:

URL

http://www.uandes.cl/

Description

Universidad de los Andes.

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

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