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

NCT02479776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-06-24

No results posted yet for this study

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.

Conditions

  • Dilated Cardiomyopathy

Interventions

BIOLOGICAL

stem cell injection

Injection of autologous bone marrow derived stem cells

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2015-01-31
Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02479776 on ClinicalTrials.gov