Clinical trial · Interventional
Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia
Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children
NCT03601416CI-TRIAL-00036544unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in children with moderate and severe bronchopulmonary dysplasia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bronchopulmonary Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Transplantation of Mesenchymal Stem Cell | Drug | — | UNRESOLVED |
| Transplantation of mesenchymal stem cell | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transplantation of Mesenchymal Stem Cell
- description
- Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.
- interventionNames
- Drug: Transplantation of mesenchymal stem cell
- type
- ACTIVE_COMPARATOR
- label
- No Transplantation of Mesenchymal Stem Cell
- description
- Mesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia.
- interventionNames
- Drug: No Transplantation of Mesenchymal Stem Cell
Primary outcomes (1)
- measure
- the accumulative duration of oxygen therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 28 Days
- Maximum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: 1. Participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy 2. The legal representative or the participant had signed consent. Exclusion Criteria: * 1\. Severe underlying diseases (e.g. systemic and hematological malignancies, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, III-IV grade pulmonary hypertension, Lung transplantation, current indications of acute surgery after lung transplantation) 2. Participants whose age is more than 1 year old.
References
Publications (4)
- BACKGROUNDAhn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21. PMID 28341525
- BACKGROUNDLaube M, Stolzing A, Thome UH, Fabian C. Therapeutic potential of mesenchymal stem cells for pulmonary complications associated with preterm birth. Int J Biochem Cell Biol. 2016 May;74:18-32. doi: 10.1016/j.biocel.2016.02.023. Epub 2016 Feb 27. PMID 26928452
- BACKGROUNDHansmann G, Fernandez-Gonzalez A, Aslam M, Vitali SH, Martin T, Mitsialis SA, Kourembanas S. Mesenchymal stem cell-mediated reversal of bronchopulmonary dysplasia and associated pulmonary hypertension. Pulm Circ. 2012 Apr-Jun;2(2):170-81. doi: 10.4103/2045-8932.97603. PMID 22837858
- DERIVEDWu X, Xia Y, Zhou O, Song Y, Zhang X, Tian D, Li Q, Shu C, Liu E, Yuan X, He L, Liu C, Li J, Liang X, Yang K, Fu Z, Zou L, Bao L, Dai J. Allogeneic human umbilical cord-derived mesenchymal stem cells for severe bronchopulmonary dysplasia in children: study protocol for a randomized controlled trial (MSC-BPD trial). Trials. 2020 Jan 31;21(1):125. doi: 10.1186/s13063-019-3935-x. PMID 32005282