drugset / Trial / NCT02479776
A Trial of Autologous Bone Marrow Derived Stem Cells in Paediatric Heart Failure
RandomizedCrossoverSingle-blindTreatment
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.
Timeline
- Start
- 2008-05
- Primary completion
- 2015-01
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | autologous bone marrow derived stem cells | Cell therapy | 1 ml | — |