Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia - 14/12/17
Abstract |
Objective |
To determine the long-term safety and outcomes of mesenchymal stem cells (MSCs) for bronchopulmonary dysplasia in premature infants enrolled in a previous phase I clinical trial up to 2 years of corrected age (CA).
Study design |
We assessed serious adverse events, somatic growth, and respiratory and neurodevelopmental outcomes at visit 1 (4-6 months of CA), visit 2 (8-12 months of CA), and visit 3 (18-24 months of CA) in a prospective longitudinal follow-up study up to 2 years' CA of infants who received MSCs (MSC group). We compared these data with those from a historical case-matched comparison group.
Results |
One of 9 infants in the MSC group died of Enterobacter cloacae sepsis at 6 months of CA, the remaining 8 infants survived without any transplantation-related adverse outcomes, including tumorigenicity. No infant in the MSC group was discharged with home supplemental oxygen compared with 22% in the comparison group. The average rehospitalization rate in the MSC group was 1.4/patient because of respiratory infections during 2 years of follow-up. The mean body weight of the MSC group at visit 3 was significantly higher compared with that of the comparison group. No infant in the MSC group was diagnosed with cerebral palsy, blindness, or developmental delay; in the comparison group, 1 infant was diagnosed with cerebral palsy and 1 with developmental delay.
Conclusions |
Intratracheal transplantation of MSCs in preterm infants appears to be safe, with no adverse respiratory, growth, and neurodevelopmental effects at 2 years' CA.
Trial registration |
ClinicalTrials.gov: NCT01632475.
Le texte complet de cet article est disponible en PDF.Keywords : mesenchymal stem cells, cell transplantation, infant, premature, cord blood stem cell transplantation, bronchopulmonary dysplasia
Abbreviations : BPD, BSID-II, CA, CAT, CLAMS, DQ, LMS, MDI, MRI, MSCs, PDI, SAEs
Plan
| Funded by the Korean Health and Medical Technology R&D Program, Ministry for Health, Welfare and Family Affairs, Republic of Korea (A102136). Samsung Medical Center and MEDIPOST Co., Ltd have issued or filed patents for ‘‘Method of treating lung diseases using cells separated or proliferated from umbilical cord blood’' under the name of Yun Sil Chang, Won Soon Park, and Yoon Sun Yang (CT/KR2007/000535). The other authors declare no conflicts of interest. |
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| Portions of this study were presented as a poster during the Pediatric Academic Society meeting, Vancouver, BC, Canada, May 3-6, 2014. |
Vol 185
P. 49 - juin 2017 Retour au numéro
Article précédent
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