Safety and efficacy of cell therapies in pediatric heart disease: a systematic review and meta-analysis.
Stem Cell Res Ther
; 11(1): 272, 2020 07 08.
Article
em En
| MEDLINE
| ID: mdl-32641168
ABSTRACT
BACKGROUND:
Adult clinical trials have reported safety and the therapeutic potential of stem cells for cardiac disease. These observations have now translated to the pediatric arena. We conducted a meta-analysis to assess safety and efficacy of cell-based therapies in animal and human studies of pediatric heart disease. METHODS ANDRESULTS:
A literature search was conducted to examine the effects of cell-based therapies on (i) safety and (ii) cardiac function. In total, 18 pre-clinical and 13 human studies were included. Pre-clinical right ventricular dysfunction was the most common animal model (80%). Cardiac-derived (28%) and umbilical cord blood (24%) cells were delivered intravenously (36%) or intramyocardially (35%). Mortality was similar between cell-based and control groups (OR 0.94; 95% CI 0.05, 17.41). Cell-based treatments preserved ejection fraction by 6.9% (p < 0.01), while intramyocardial at a dose of 1-10 M cells/kg optimized ejection fraction. Clinical single ventricle physiology was the most common cardiac disease (n = 9). Cardiac tissue was a frequent cell source, dosed from 3.0 × 105 to 2.4 × 107 cells/kg. A decrease in adverse events occurred in the cell-based cohort (OR 0.17, p < 0.01). Administration of cell-based therapies improved ejection fraction (MD 4.84; 95% CI 1.62, 8.07; p < 0.01).CONCLUSIONS:
In this meta-analysis, cell-based therapies were safe and improved specific measures of cardiac function. Implications from this review may provide methodologic recommendations (source, dose, route, timing) for future clinical trials. Of note, many of the results described in this study pattern those seen in adult stem cell reviews and meta-analyses.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Disfunção Ventricular Direita
/
Terapia Baseada em Transplante de Células e Tecidos
Tipo de estudo:
Guideline
/
Systematic_reviews
Limite:
Animals
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Child
/
Humans
Idioma:
En
Revista:
Stem Cell Res Ther
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Estados Unidos