Actively Recruiting
Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases
Led by Shandong Qilu Stem Cells Engineering Co., Ltd. · Updated on 2024-05-24
120
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
S
Shandong Qilu Stem Cells Engineering Co., Ltd.
Lead Sponsor
Q
Qilu Children's Hospital of Shandong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment. Thus, how to better prevent such diseases is currently a key research topic in the international field. The use of cord blood-derived mononuclear cells may promote to save lives and improve patient outcomes.
CONDITIONS
Official Title
Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For children with hypoxic-ischemic encephalopathy (HIE): meet the diagnostic criteria for HIE.
- For children with bronchopulmonary dysplasia (BPD): preterm infants with gestational age of 25-30 weeks.
- For children with bronchopulmonary dysplasia (BPD): birth weight between 401 and 1249 grams.
- For children with bronchopulmonary dysplasia (BPD): assessed risk of BPD greater than 60% based on the NCHD Neonatal Cooperative Network scoring system.
- For children with short bowel syndrome (SBS): postoperative SBS caused by neonatal necrotizing enterocolitis or digestive tract malformations such as intestinal atresia, anal atresia, or intestinal stenosis.
- Parents have read the study information, agree to the treatment, and have signed informed consent.
You will not qualify if you...
- For children with HIE: unable or unwilling to provide informed consent or unable to comply with trial requirements.
- For children with BPD: presence of severe anemia, severe intracranial hemorrhage, pulmonary hemorrhage, congenital respiratory malformations (including posterior nostril atresia, tracheoesophageal fistula, cleft palate), complicated congenital heart disease, diaphragmatic hernia, shock, or other serious comorbidities.
- For children with BPD: presence of congenital inherited metabolic diseases, endocrine diseases, severe congenital malformations, or other diseases that affect lung development.
- For children with BPD: unable or unwilling to provide informed consent or unable to comply with trial requirements.
- For children with SBS: unable or unwilling to provide informed consent or unable to comply with trial requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qilu Children's Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
Research Team
Y
Yujie Han, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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