NCT01739777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

2.5 years

First QC Date

November 29, 2012

Last Update Submit

June 2, 2015

Conditions

Dilated Cardiomyopathy

Keywords

Heart FailureCoronary Heart DiseaseAdult Stem CellsUmbilical Progenitor CellsUmbilical Cord Stem Cells AllogenicLeft Ventricular FunctionIntravenous Injection

Outcome Measures

Primary Outcomes (1)

  • • Change in global left ventricular ejection fraction

    3, 6, 12 months

Secondary Outcomes (4)

  • • Change in functional capacity measured in O2 consumption

    0, 3, 6, 12 months

  • • Occurrence of major adverse cardiac event

    12 months

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

    0, 3, 6, 12 months

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

    0, 3, 6, 12 months

Other Outcomes (2)

  • Measures of anti & pro inflammatory cytokines profile

    0-15-90 days

  • Change in quality of life

    0-6-12 months

Study Arms (2)

ucMSC

EXPERIMENTAL

Umbilical cord derived mesenchymal are injected intravenously to Patients.

Biological: ucMSC

Controls

PLACEBO COMPARATOR

Intravenous placebo solution are administrated to Patients.

Other: Controls

Interventions

ucMSCBIOLOGICAL

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

Also known as: Umbilical Cord Mesenchymal Stem Cells
ucMSC
ControlsOTHER

Autologous Serum will administrated as placebo

Controls

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de los Andes

Santiago, Chile

Location

Related Publications (2)

  • 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.

    PMID: 19958962BACKGROUND

  • 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.

    PMID: 28974553DERIVED

Related Links

MeSH Terms

Conditions

Cardiomyopathy, DilatedHeart FailureCoronary Disease

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyocardial IschemiaVascular Diseases

Study Officials

  • Jorge Bartolucci, Dr.

    Universidad de Los Andes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical director of Celular Therapy

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 3, 2012

Study Start

December 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

CL(1)