Actively Recruiting
Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants
Led by Meridigen Biotech Co., Ltd. · Updated on 2023-12-04
9
Participants Needed
1
Research Sites
457 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.
CONDITIONS
Official Title
Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonatal infants aged between 3 and 30 days
- Born at gestational age between 23 and 29 weeks
- Postmenstrual age at treatment no more than 36 weeks
- Birth weight between 501 grams and 1249 grams
- Have an endotracheal tube in place as part of standard care at screening and treatment
- Receiving mechanical ventilation with oxygen fraction (FiO2) of 0.25 or greater at screening
- Experienced deterioration or no change in mechanical ventilation settings within 24 hours before enrollment
- Written informed consent provided by parents, legal guardians, or representatives who agree to all study procedures including long-term safety follow-up
You will not qualify if you...
- Major congenital abnormalities, including neurological (e.g., anencephaly), hepatic, renal, or cardiovascular (except patent ductus arteriosus)
- Known genetic syndromes
- Any condition making them ineligible as judged by the investigator
- Elevated C-reactive protein over 30 mg/L or infections such as pneumonia, sepsis, or shock
- Severe intraventricular hemorrhage grade 3 or higher
- Active pulmonary hemorrhage or air leak syndrome
- Abnormal liver function (AST, ALT >150 U/L, direct bilirubin >2 mg/dL, total bilirubin >15 mg/dL) or abnormal kidney function (creatinine >1 mg/dL or low urine output)
- Known infection with HIV or CMV
- Expected surgery within 24 hours before or after treatment
- Expected to receive other intratracheal treatments, including surfactant, within 72 hours before or after treatment
- Currently participating in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Chen-Kung University Hospital
Tainan, Taiwan
Actively Recruiting
Research Team
C
Claire Liao, MS
CONTACT
J
Joseph Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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