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

NCT06427642 | Recruiting

• 1 other identifier: MNCs-2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxic-Ischemic Encephalopathy; Bronchopulmonary Dysplasia; Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse reactions

  Monitor oxygen, heart rate, temperature, rash, infection, etc

  Within 12 hours after UCB-MNCs infusion

Secondary Outcomes (9)

• Incidence of complications

  a year

• Imaging test results

  2 weeks and 6 months after UCB-MNCs infusion

• Electroencephalography (EEG) results

  7 days UCB-MNCs infusion

• Ventilator supporting time

  1 month after UCB-MNCs infusion

• Change of Gross Motor Performance Measure (GMPM)

  1, 3, 6 months after UCB-MNCs infusion

Study Arms (6)

Experimental group for children with HIE

EXPERIMENTAL

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

Control group for children with HIE

ACTIVE COMPARATOR

Mild hypothermia therapy is given for 72 hours to maintain anal temperature between 33.5°C and 34°C

Device: Mild hypothermia therapy

Experimental group for children with BPD

EXPERIMENTAL

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

Control group for children with BPD

ACTIVE COMPARATOR

Clinical routine treatment

Device: Breathing support technique

Experimental group for children with SBS

EXPERIMENTAL

Intravenous infusion of UCB-MNCs

Biological: Mononuclear cells; Procedure: Total parenteral nutrition

Control group for children with SBS

ACTIVE COMPARATOR

Clinical routine treatment

Procedure: Total parenteral nutrition

Interventions

Mononuclear cells BIOLOGICAL

UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation

Experimental group for children with BPD; Experimental group for children with HIE; Experimental group for children with SBS

Mild hypothermia therapy DEVICE

Mild hypothermia therapy via hypothermia therapy apparatus

Control group for children with HIE; Experimental group for children with HIE

Breathing support technique DEVICE

Breathing support via ventilator

Control group for children with BPD; Experimental group for children with BPD

Total parenteral nutrition PROCEDURE

Liquid nutrition injected directly into the bloodstream

Control group for children with SBS; Experimental group for children with SBS

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Qilu Stem Cells Engineering Co., Ltd.: lead
• Qilu Children's Hospital of Shandong University: collaborator

Study Sites (1)

Qilu Children's Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Bronchopulmonary Dysplasia; Short Bowel Syndrome

Interventions

Parenteral Nutrition, Total

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Parenteral Nutrition; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Xiaoying Li, MD

  Qilu Children's Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujie Han, MD

CONTACT

+86 187 5414 6336; 410358192@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 24, 2024
• Study Start: April 1, 2022
• Primary Completion: May 30, 2024
• Study Completion: April 30, 2025
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)