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Trial record 75 of 157 for:    Idiopathic Dilated Cardiomyopathy

Intracoronary Transplantation of Bone Marrow Derived Mononuclear Cells in Pediatric Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT02256501
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Nasser Aghdami MD., PhD, Royan Institute

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.

Condition or disease Intervention/treatment Phase
Cardiomyopathy Biological: Mono Nuclear Cell (MNC) transplantation Phase 1 Phase 2

Detailed Description:
Dilated cardiomyopathy as the most common form of cardiomyopathy is a rare but life-threatening disorder in children. The primary cause of nearly 37 % of children with DCM was unknown at diagnosis. Despite of the developing in the medical and surgical treatment during the past several decades, standard treatments (including Digitalis, diuretics, inhibitors of ACE, beta blockers, antiplatelet drugs and treatments Antiarrhythmic), may stabilize the condition, but will not restore heart function to its previous condition. Therapy remains complex and expensive. For some not all children the heart transplantation is only option and mortality continues to be high, also. Stem cell and cell-based therapies offer an innovative approach to reverse cardiac structure and function towards normal, possibly reducing the need for aggressive therapies and cardiac transplantation. According to the inclusion and exclusion criteria of trial, 32 patients with left ventricular ejection fraction less than 45% who resistance to the standard medical therapy were randomly allocated in 2 groups including BM-derived mononuclear (n=16) and control (n=16). Only the MNC group underwent the bone marrow aspiration and intracoronary injection. The investigators followed all of patients at 2 weeks, 1, 2, 4 and 6 months after transplantation for cell therapy group or registration for placebo by physical examination, laboratory tests and imaging such as echocardiography, CXR and CMR.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intracoronary Transplantation of Autologous Bone Marrow Derived Mononuclear Cells (MNC) in Idiopathic Dilated Cardiomyopathy in Pediatric Patients: Clinical Trial Phase I/II
Actual Study Start Date : June 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Mono Nunlear Cell (MNC)
The patients with idiopathic dilated cardiomyopathy who underwent intracoronary injection of autologous bone marrow-derived mononuclear cells .
Biological: Mono Nuclear Cell (MNC) transplantation
Intracoronary administration of autologous bone marrow derived mononuclear cells

No Intervention: Control
The patients with cardiomyopathy that are under observe during the study.



Primary Outcome Measures :
  1. Death [ Time Frame: 3months ]
    The rate of patients' death 3 months after cell transplantation

  2. Arrest [ Time Frame: 3 months ]
    The rate of patients' arrests 3 months after cell transplantation


Secondary Outcome Measures :
  1. Dysrhythmia [ Time Frame: 3 months ]
    The rate of dysarthymia 3 months after cell transplantation

  2. Heart transplantation [ Time Frame: 3 months ]
    The rate of demand for heart transplantation 3 months after cell transplantation.

  3. Hospital admission for heart failure [ Time Frame: 3 months ]
    The rate of hospital administration 3 months after cell transplantation.



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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Congenital Heart Disease
  2. Active infection less than one month
  3. Dysrhythmia
  4. Cardiogenic shock
  5. Renal failure
  6. Immune Deficiency (Documentation)
  7. Terminal illness or malignancy(Documentation)
  8. TORCH (Documentation)
  9. Metabolic disorder (Documentation)
  10. Neuromuscular disorder (Documentation)
  11. Autoimmune disease (Documentation)
  12. Developmental delay
  13. Cytotoxic drugs
  14. Previous bone marrow transplant
  15. Contraindications to CMR such as metallic implants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256501


Locations
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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Nasser Aghdami MD., PhD
Investigators
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Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: 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
Principal Investigator: Koorosh Vahidshahi, MD Department of Pediatric Cardiology, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran

Additional Information:
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Responsible Party: Nasser Aghdami MD., PhD, Hear of department of Regenerative Medicine of Royan Institute 7 cell therapy center, Royan Institute
ClinicalTrials.gov Identifier: NCT02256501     History of Changes
Other Study ID Numbers: Royan-Heart-004
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Keywords provided by Nasser Aghdami MD., PhD, Royan Institute:
Dilated cardiomyopathy pediatric heart failure cell therapy
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases