NCT02256501

Brief Summary

According to the high morbidity and mortality of idiopathic Dilated CardioMyopathy (IDCM) in pediatric, new modality of treatment is emerging. There are some case reports of administration of stem cell therapy. The investigators design the first randomized clinical trial in this setting. The investigators enroll 32 pediatric IDCM patients in two groups (16 pts. in each group including cell therapy and control). The investigators assess the safety and efficacy of intracoronary transplantation of autologous bone marrow derived mononuclear cells in this patients compared to control group.

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 Jun 2013

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

Study Start

First participant enrolled

June 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

2.8 years

First QC Date

October 1, 2014

Last Update Submit

April 26, 2017

Conditions

Cardiomyopathy

Keywords

Dilated cardiomyopathy pediatric heart failure cell therapy

Outcome Measures

Primary Outcomes (2)

  • Death

    The rate of patients' death 3 months after cell transplantation

    3months

  • Arrest

    The rate of patients' arrests 3 months after cell transplantation

    3 months

Secondary Outcomes (3)

  • Dysrhythmia

    3 months

  • Heart transplantation

    3 months

  • Hospital admission for heart failure

    3 months

Study Arms (2)

Mono Nunlear Cell (MNC)

EXPERIMENTAL

The patients with idiopathic dilated cardiomyopathy who underwent intracoronary injection of autologous bone marrow-derived mononuclear cells .

Biological: Mono Nuclear Cell (MNC) transplantation

Control

NO INTERVENTION

The patients with cardiomyopathy that are under observe during the study.

Interventions

Mono Nuclear Cell (MNC) transplantationBIOLOGICAL

Intracoronary administration of autologous bone marrow derived mononuclear cells

Mono Nunlear Cell (MNC)

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 1-16 year(s)
  • LVEF \<45% (echocardiography)
  • Duration of diagnosis more than 3 months
  • Resistance to Standard therapy more than 2 months
  • Informed consent

You may not qualify if:

  • Congenital Heart Disease
  • Active infection less than one month
  • Dysrhythmia
  • Cardiogenic shock
  • Renal failure
  • Immune Deficiency (Documentation)
  • Terminal illness or malignancy(Documentation)
  • TORCH (Documentation)
  • Metabolic disorder (Documentation)
  • Neuromuscular disorder (Documentation)
  • Autoimmune disease (Documentation)
  • Developmental delay
  • Cytotoxic drugs
  • Previous bone marrow transplant
  • Contraindications to CMR such as metallic implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

MeSH Terms

Conditions

Cardiomyopathies

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Nasser Aghdami, MD,PhD

    Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute

    STUDY DIRECTOR

  • Mohammad Mahdavi, MD

    Department of Pediatric Cardiology, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran

    STUDY DIRECTOR

  • Koorosh Vahidshahi, MD

    Department of Pediatric Cardiology, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Hear of department of Regenerative Medicine of Royan Institute 7 cell therapy center

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 3, 2014

Study Start

June 1, 2013

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

IR(1)