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

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

Recruiting
1-28 years
All
Phase N/A

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Overview

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 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.

Study details
    Hypoxic-Ischemic Encephalopathy
    Bronchopulmonary Dysplasia
    Short Bowel Syndrome

NCT06427642

Shandong Qilu Stem Cells Engineering Co., Ltd.

27 May 2024

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