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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure, Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 28 days
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Qilu Children's Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Yujie Han, MD
410358192@qq.com
+86 187 5414 6336
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 120
Treatments
Experimental: Experimental group for children with HIE
Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient
Active_comparator: 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
Experimental: Experimental group for children with BPD
Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient
Active_comparator: Control group for children with BPD
Clinical routine treatment
Experimental: Experimental group for children with SBS
Intravenous infusion of UCB-MNCs
Active_comparator: Control group for children with SBS
Clinical routine treatment
Sponsors
Leads: Shandong Qilu Stem Cells Engineering Co., Ltd.
Collaborators: Qilu Children's Hospital of Shandong University

This content was sourced from clinicaltrials.gov