Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
NCT ID: NCT03645525
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2019-12-01
2023-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mesenchymal stem cell
Human Umbilical Cord-derived Mesenchymal stem cell in the saline
Human Umbilical Cord-derived Mesenchymal stem cell
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
saline without mesenchymal stem cell
placebo
saline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Human Umbilical Cord-derived Mesenchymal stem cell
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
saline
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age
Exclusion Criteria
* Patients with IVH more than 3 grade
* Patients with severe sepsis
* Patients with active pulmonary hemorrhage
2 Weeks
3 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Hospital of Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chen Chao, PhD,MD
Role: STUDY_DIRECTOR
Chiledren's Hospital of Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EKYYIUMTB
Identifier Type: -
Identifier Source: org_study_id