- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645525
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD) (IUMTB)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Chen Chao, PhD,MD
- Phone Number: 86-13681709999
- Email: chen6010@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201102
- Children's Hospital of Fudan University
-
Shanghai, Shanghai, China, 200011
- Obstetrics and Gynecology Hospital of Fudan University
-
Shanghai, Shanghai, China, 201204
- Shanghai first maternity and infant hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age
- Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age
Exclusion Criteria:
- Patients with severe congenital diseases
- Patients with IVH more than 3 grade
- Patients with severe sepsis
- Patients with active pulmonary hemorrhage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mesenchymal stem cell
Human Umbilical Cord-derived Mesenchymal stem cell in the saline
|
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
|
Placebo Comparator: placebo
saline without mesenchymal stem cell
|
saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen requirement 3 days after transplantation
Time Frame: 3 days
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen requirement 7 days after transplantation
Time Frame: 7 days
|
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
Time Frame: up to 36 weeks PMA
|
The duration from transplantation to weaning from ventilator
|
up to 36 weeks PMA
|
Incidence of severe BPD
Time Frame: up to 36 weeks PMA
|
percentage of participants with severe BPD ,diagnosed at 36 weeks PMA
|
up to 36 weeks PMA
|
Survival rate
Time Frame: up to 36 weeks PMA
|
Percentage of participants who survived up to 36 weeks PMA
|
up to 36 weeks PMA
|
Temperature
Time Frame: 3 days
|
Temporal profiles of temperature
|
3 days
|
Heart rate
Time Frame: 3 days
|
Temporal profiles of heart rate
|
3 days
|
Respiratory rate
Time Frame: 3 days
|
Temporal profiles of respiratory rate
|
3 days
|
Duration of CPAP treatment
Time Frame: up to 36 weeks PMA
|
Duration of CPAP treatment
|
up to 36 weeks PMA
|
Percentage of participants treated with steroids for weaning from ventilator
Time Frame: up to 36 weeks PMA
|
Percentage of participants treated with steroids for weaning from ventilator
|
up to 36 weeks PMA
|
Growth velocity (Z-score)
Time Frame: up to 36 weeks PMA
|
percentile for body weight, height, and head circumference
|
up to 36 weeks PMA
|
bronohoalveolar lavage (BAL) cytokine level
Time Frame: 7 days
|
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
Time Frame: 7 days
|
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
|
Collaborators and Investigators
Investigators
- Study Director: Chen Chao, PhD,MD, Chiledren's Hospital of Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKYYIUMTB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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