Using cord blood cells to treat severe neonatal diseases

Efficacy Evaluation of Umbilical Cord Blood-derived Mononuclear Cells in the Treatment of Refractory Neonatal Diseases

This study tests if using special cells from umbilical cord blood can help newborns with serious health issues feel better when combined with other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 1 Day to 28 Days
• Sex: All
• Sponsor: Shandong Qilu Stem Cells Engineering Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06427642 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of cord blood-derived mononuclear cells in treating refractory neonatal conditions such as hypoxic-ischemic encephalopathy, bronchopulmonary dysplasia, and short bowel syndrome. The approach involves administering these cells alongside mild hypothermia therapy, breathing support techniques, and total parenteral nutrition. The goal is to improve patient outcomes and potentially save lives in infants suffering from these serious conditions.

Who should consider this trial

Good fit: Ideal candidates include infants diagnosed with hypoxic-ischemic encephalopathy, preterm infants at high risk for bronchopulmonary dysplasia, or infants with postoperative short bowel syndrome.

Not a fit: Patients who do not meet the specific diagnostic criteria for the targeted conditions or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and health outcomes for infants with severe neonatal diseases.

How similar studies have performed: While the use of cord blood-derived cells is a promising approach, the specific application in these neonatal conditions is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Jinan, Shandong

• Qilu Children's Hospital of Shandong University — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Xiaoying Li, MD — Qilu Children's Hospital of Shandong University
• Study coordinator: Yujie Han, MD

Conditions Hypoxic-Ischemic Encephalopathy; Bronchopulmonary Dysplasia; Short Bowel Syndrome