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A Trial of Autologous Bone Marrow Derived Stem Cells in Paediatric Heart Failure

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ClinicalTrials.gov Identifier: NCT02479776
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary:

The bone marrow mononuclear cell fraction has been used as therapy after myocardial infarction and in dilated cardiomyopathy in adults. The absence of adult co-morbidities may enhance the potential effectiveness of pediatric stem cells.This study is a randomized, crossover, placebo controlled pilot study to primarily determine the safety and feasibility of stem cell intracoronary therapy in children. Secondary end points are MRI measurements and NTproBNP.

Ten children (mean age 7.2 years, range 2.2-14.1, 6 male) with dilated cardiomyopathy (NYHA/ Ross Classification 2-4) will be recruited. Bone marrow aspiration MRI and cell injection are performed under the same anaesthetic. Patients will be crossed over at 6 months.


Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Biological: stem cell injection Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Study of Autologous Bone Marrow Derived Stem Cells in Pediatric Dilated Cardiomyopathy
Study Start Date : May 2008
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
Active Comparator: Stem cell injection
Stem cells are injected and patients crossed over to placebo at 6 months
Biological: stem cell injection
Injection of autologous bone marrow derived stem cells

Placebo Comparator: saline injection
saline is injected and patients crossed over to active arm at 6 months



Primary Outcome Measures :
  1. adverse effect [ Time Frame: 6 months ]
    death , transplant or major adverse effect


Secondary Outcome Measures :
  1. Blood for NT pro BNP [ Time Frame: 6 months ]
    blood sample

  2. MRI volumes [ Time Frame: 6 months ]
    MRI derived ventricular volumes



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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 1-16 years.
  • Diagnosis of dilated cardiomyopathy

Exclusion Criteria:

  • Age less than 1 year or over 17 years.
  • A need for high dependency or intensive care and congenital heart disease
  • Viral infection that would preclude the use of hospital Cell Therapy Laboratory facilities
  • Active malignancy
  • Unstable cardiac drug therapy

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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02479776     History of Changes
Other Study ID Numbers: 07CC37
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly