Trials / Unknown
UnknownNCT01207869
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia
Intratracheal Instillation of Umbilical Cord-derived Mesenchymal Stem Cells as a Rescue Treatment for Severe Bronchopulmonary Dysplasia
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- China Medical University Hospital · Academic / Other
- Sex
- All
- Age
- 1 Week – 6 Months
- Healthy volunteers
- Not accepted
Summary
Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely premature infant with severe BPD to establish whether intratracheal instillation of umbilical cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.
Conditions
- Bronchopulmonary Dysplasia
- Extremely Premature Infants
- Severe BPD That Conventional Therapies Has Failed
- No Severe Congenital Anomalies
- no Severe IVH Neither Cystic PVL
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ucMSCs | the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube |
| OTHER | Normal saline | the same amount of ucMSCs suspension will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2012-06-01
- Completion
- 2012-07-01
- First posted
- 2010-09-23
- Last updated
- 2010-09-23
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01207869. Inclusion in this directory is not an endorsement.