Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases

Launched by SHANDONG QILU STEM CELLS ENGINEERING CO., LTD. · May 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of cord blood-derived mononuclear cells (UCB-MNCs) to help treat serious conditions in newborns, specifically hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), and short bowel syndrome (SBS). These conditions are difficult to treat and can lead to significant health problems for affected infants. The hope is that using these special cells might improve outcomes and even save lives.

To participate in the trial, children aged 1 to 28 who have been diagnosed with HIE, are preterm infants at high risk for BPD, or have postoperative SBS may be eligible. Parents of these children will need to read the information provided about the study and give their consent for their child to participate. If your child is considered for the trial, they will be closely monitored throughout the treatment to ensure their safety and gather important information about how well the UCB-MNCs work. This trial is currently recruiting participants, and it’s an important step in finding better ways to manage these challenging conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • For children with hypoxic-ischemic encephalopathy (HIE): meet the diagnostic criteria for HIE.
• • For children with bronchopulmonary dysplasia (BPD): 1) preterm infants with definite gestational age of 25-30 weeks; 2) birth weight 401-1249 g; 3) the risk of BPD was assessed to be greater than 60%. The scoring was based on the BPD high risk scoring system established by the NCHD Neonatal Cooperative Network; 4)parents read the subject's instructions, agreed to the treatment and signed the informed consent.
• • For children with short bowel syndrome (SBS): 1) postoperative short bowel syndrome caused by neonatal necrotizing enterocolitis and other causes (developmental malformations of the digestive tract: intestinal atresia, anal atresia, intestinal stenosis, etc.); 2) parents read the subject's instructions, agreed to the treatment and signed the informed consent.
• Exclusion Criteria:
• • For children with HIE: unable or unwilling to provide informed consent or unable to comply with trial requirements.
• • For children with BPD: 1) with severe anemia, severe intracranial hemorrhage, pulmonary hemorrhage, congenital respiratory malformations (posterior nostril atresia, tracheoesophageal fistula, cleft palate, etc.), complicated congenital heart disease, diaphragmatic hernia, shock, other serious comorbidities or complications (congenital inherited metabolic diseases, endocrine diseases, severe congenital malformations and other diseases that affect lung development); 2) 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.