Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases
Efficacy Evaluation of Umbilical Cord Blood-derived Mononuclear Cells in the Treatment of Refractory Neonatal Diseases
Shandong Qilu Stem Cells Engineering Co., Ltd.
120 participants
Apr 1, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria3
- 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.
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Interventions
UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation
Mild hypothermia therapy via hypothermia therapy apparatus
Breathing support via ventilator
Liquid nutrition injected directly into the bloodstream
Locations(1)
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NCT06427642