Not provided
Not provided
Not provided
Not provided
The certification of cell-based treatment in the settings need to be updated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking.
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cell | Experimental | Human Umbilical Cord-derived Mesenchymal stem cell in the saline |
|
| placebo | Placebo Comparator | saline without mesenchymal stem cell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Umbilical Cord-derived Mesenchymal stem cell | Drug | The Human Umbilical Cord-derived Mesenchymal stem cells suspension (2×10^7/kg per KG of the infant 's weight ) will be instilled once through a catheter into the infant' s endotracheal tube |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen requirement 3 days after transplantation | Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in % | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen requirement 7 days after transplantation | Temporal profiles of the fraction of inspiration oxygen 7 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in % | 7 days |
| Duration of ventilator dependence |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chen Chao, PhD,MD | Chiledren's Hospital of Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Hospital of Fudan University | Shanghai | Shanghai Municipality | 200011 | China | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | saline |
|
The duration from transplantation to weaning from ventilator |
| up to 36 weeks PMA |
| Incidence of severe BPD | percentage of participants with severe BPD ,diagnosed at 36 weeks PMA | up to 36 weeks PMA |
| Survival rate | Percentage of participants who survived up to 36 weeks PMA | up to 36 weeks PMA |
| Temperature | Temporal profiles of temperature | 3 days |
| Heart rate | Temporal profiles of heart rate | 3 days |
| Respiratory rate | Temporal profiles of respiratory rate | 3 days |
| Duration of CPAP treatment | Duration of CPAP treatment | up to 36 weeks PMA |
| Percentage of participants treated with steroids for weaning from ventilator | Percentage of participants treated with steroids for weaning from ventilator | up to 36 weeks PMA |
| Growth velocity (Z-score) | percentile for body weight, height, and head circumference | up to 36 weeks PMA |
| bronohoalveolar lavage (BAL) cytokine level | BAL were collected 7 days after transplantation for cytokine (IL-6，IL-8，TNF-α，TGF-β,VEGF,HGF) level examination, measured in pg/ml | 7 days |
| The severity of BPD in X-ray patterns | A chest X-ray was performed in participants before and after transplantation. The severity of BPD (mild，moderate，severe) was assessed by a single radiographic doctor who is blind about randomization | 7 days |
| Children's Hospital of Fudan University |
| Shanghai |
| Shanghai Municipality |
| 201102 |
| China |
| Shanghai First Maternity and Infant Hospital | Shanghai | Shanghai Municipality | 201204 | China |
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided