Mesenchymal Stem Cells for Bronchopulmonary Dysplasia: Phase 1 Dose-Escalation Clinical Trial - 16/04/14
Abstract |
Objective |
To assess the safety and feasibility of allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation in preterm infants.
Study design |
In a phase I dose-escalation trial, we assessed the safety and feasibility of a single, intratracheal transplantation of hUCB-derived MSCs in preterm infants at high risk for bronchopulmonary dysplasia (BPD). The first 3 patients were given a low dose (1 × 107 cells/kg) of cells, and the next 6 patients were given a high dose (2 × 107 cells/kg). We compared their adverse outcomes, including BPD severity, with those of historical case-matched comparison group.
Results |
Intratracheal MSC transplantation was performed in 9 preterm infants, with a mean gestational age of 25.3 ± 0.9 weeks and a mean birth weight of 793 ± 127 g, at a mean of 10.4 ± 2.6 days after birth. The treatments were well tolerated, without serious adverse effects or dose-limiting toxicity attributable to the transplantation. Levels of interleukin-6, interleukin-8, matrix metalloproteinase-9, tumor necrosis factor α, and transforming growth factor β1 in tracheal aspirates at day 7 were significantly reduced compared with those at baseline or at day 3 posttransplantation. BPD severity was lower in the transplant recipients, and rates of other adverse outcomes did not differ between the comparison group and transplant recipients.
Conclusion |
Intratracheal transplantation of allogeneic hUCB-derived MSCs in preterm infants is safe and feasible, and warrants a larger and controlled phase II study.
Le texte complet de cet article est disponible en PDF.Keyword : BPD, HGF, hUCB, IL, IVH, KFDA, MMP, MSC, PDA, SAE, TGF, TNF, VEGF
Plan
| ☆ | This is an open access article under the CC BY-NC-ND license (3.0/). |
| Funded by the Korean Health and Medical Technology R&D Program, Ministry for Health, Welfare and Family Affairs, Republic of Korea (A102136). Human umbilical cord blood–derived mesenchymal stem cells were supplied by MEDIPOST Co, Ltd; the sponsor had no involvement in study design, the collection, analysis, or interpretation of data; writing of the report; or the decision to submit the manuscript for publication. W.O. is a board member and stockholder of MEDIPOST Co, Ltd. 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 Y.C., W.P., and Yoon Sun Yang (not affiliated with this article) (application PCT/KR2007/000535). S.Ahn, H.Y., and S.Sung declare no conflicts of interest. |
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| Registered with clinicaltrials.gov: NCT01297205. |
Vol 164 - N° 5
P. 966 - mai 2014 Retour au numéro
Article précédent
- Encephalopathy of Congenital Heart Disease– Destructive and Developmental Effects Intertwined
- Joseph J. Volpe
- Feasibility of Autologous Cord Blood Cells for Infants with Hypoxic-Ischemic Encephalopathy
- C. Michael Cotten, Amy P. Murtha, Ronald N. Goldberg, Chad A. Grotegut, P. Brian Smith, Ricki F. Goldstein, Kimberley A. Fisher, Kathryn E. Gustafson, Barbara Waters-Pick, Geeta K. Swamy, Benjamin Rattray, Siddhartha Tan, Joanne Kurtzberg
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