Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases
NCT ID: NCT06427642
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2022-04-01
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group for children with HIE
Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient
Mononuclear cells
UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation
Mild hypothermia therapy
Mild hypothermia therapy via hypothermia therapy apparatus
Control group for children with HIE
Mild hypothermia therapy is given for 72 hours to maintain anal temperature between 33.5°C and 34°C
Mild hypothermia therapy
Mild hypothermia therapy via hypothermia therapy apparatus
Experimental group for children with BPD
Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient
Mononuclear cells
UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation
Breathing support technique
Breathing support via ventilator
Control group for children with BPD
Clinical routine treatment
Breathing support technique
Breathing support via ventilator
Experimental group for children with SBS
Intravenous infusion of UCB-MNCs
Mononuclear cells
UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation
Total parenteral nutrition
Liquid nutrition injected directly into the bloodstream
Control group for children with SBS
Clinical routine treatment
Total parenteral nutrition
Liquid nutrition injected directly into the bloodstream
Interventions
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Mononuclear cells
UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation
Mild hypothermia therapy
Mild hypothermia therapy via hypothermia therapy apparatus
Breathing support technique
Breathing support via ventilator
Total parenteral nutrition
Liquid nutrition injected directly into the bloodstream
Eligibility Criteria
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Inclusion Criteria
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 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.
1 Day
28 Days
ALL
No
Sponsors
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Qilu Children's Hospital of Shandong University
OTHER
Shandong Qilu Stem Cells Engineering Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoying Li, MD
Role: PRINCIPAL_INVESTIGATOR
Qilu Children's Hospital of Shandong University
Locations
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Qilu Children's Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MNCs-2024
Identifier Type: -
Identifier Source: org_study_id
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