An interventional study of Mononuclear cells and Mild hypothermia therapy in Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia and Short Bowel Syndrome, sponsored by Shandong Qilu Stem Cells Engineering Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Shandong Qilu Stem Cells Engineering Co., Ltd. · Not applicable, Interventional, and Treatment
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.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 95 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Shandong Qilu Stem Cells Engineering Co., Ltd. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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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 .
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient
Biological: Mononuclear cells · Device: Mild hypothermia therapy
Mild hypothermia therapy is given for 72 hours to maintain anal temperature between 33.5°C and 34°C
Device: Mild hypothermia therapy
Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient
Biological: Mononuclear cells · Device: Breathing support technique
Clinical routine treatment
Device: Breathing support technique
Intravenous infusion of UCB-MNCs
Biological: Mononuclear cells · Procedure: Total parenteral nutrition
Clinical routine treatment
Procedure: Total parenteral nutrition
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
Incidence of adverse reactions
Monitor oxygen, heart rate, temperature, rash, infection, etc
Time frame: Within 12 hours after UCB-MNCs infusion
Incidence of complications
Children with BPD: The incidence of various complications such as pneumothorax, necrotizing enterocolitis (NEC), intraventricular hemorrhage (grade 3 and above), persistent pulmonary hypertension (PPHN), retinopathy of prematurity (ROP)
Time frame: a year
Imaging test results
Children with HIE: Brain diffusion tensor imaging (DTI) and 18F-Fluorodeoxyglucose positron emission tomography (18F-FDG-PET/CT)
Time frame: 2 weeks and 6 months after UCB-MNCs infusion
Electroencephalography (EEG) results
Children with HIE: The frequency of seizures will be measured via EEG. Seizures appear on EEG as a sudden and transient rise in the lower and/or upper borders of amplitude
Time frame: 7 days UCB-MNCs infusion
Ventilator supporting time
Ventilator supporting time and oxygen demand will be recorded as important indications for clinical prognosis for children with HIE or BPD
Time frame: 1 month after UCB-MNCs infusion
Change of Gross Motor Performance Measure (GMPM)
GMPM is a standardized measurement tool for assessing quality of movement for children with HIE. Higher value means better motor quality
Time frame: 1, 3, 6 months after UCB-MNCs infusion
Change of Gross Motor Function Measure (GMFM)
GMFM is a standardized measurement tool for assessing motor function for children with HIE. It consists of lying \& rolling, sitting, crawling \& kneeling, standing, etc. Higher value means better gross motor function
Time frame: 1, 3, 6 months after UCB-MNCs infusion
Biomarker of HIE
pNF-H, marker of central nervous system axonal damage
Time frame: 7 days after UCB-MNCs infusion
Biomarker of BPD
AGER, marker of lung epithelial cell damage
Time frame: 7 days after UCB-MNCs infusion
Inflammatory indicators concentrations
Serum IL-6, IL-8, TNF concentrations will be measured via ELISA for children with HIE, BPD or SBS
Time frame: 7 days after UCB-MNCs infusion
Plan to share: No
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Shandong Qilu Stem Cells Engineering Co., Ltd.