Hypoxic-Ischemic EncephalopathyNCT06427642
Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases
A study testing Mononuclear cells, Mild hypothermia therapy and Breathing support technique in people with Hypoxic-Ischemic Encephalopathy and Bronchopulmonary Dysplasia, run by Shandong Qilu Stem Cells Engineering Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia, Short Bowel Syndrome
- What is being tested?
- Mononuclear cells, Mild hypothermia therapy and Breathing support technique
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Children's Hospital of Shandong University
Jinan, Shandong
Xiaoying Li, lxy_jn@sina.com
About this study
Official title: Efficacy Evaluation of Umbilical Cord Blood-derived Mononuclear Cells in the Treatment of Refractory Neonatal Diseases
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.
- Being tested
- Mononuclear cells, Mild hypothermia therapy, Breathing support technique, Total parenteral nutrition
- Medical subject headings
- Hypoxia-Ischemia, Brain, Bronchopulmonary Dysplasia, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mononuclear cellsBiological
UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation
Mild hypothermia therapyDevice
Mild hypothermia therapy via hypothermia therapy apparatus
Breathing support techniqueDevice
Breathing support via ventilator
Total parenteral nutritionProcedure or surgery
Liquid nutrition injected directly into the bloodstream
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Biological: Mononuclear cells; Device: Breathing support technique |
| Control group for children with BPD | Active comparator | Clinical routine treatment Receives: Device: Breathing support technique |
| Experimental group for children with SBS | Experimental | Intravenous infusion of UCB-MNCs Receives: Biological: Mononuclear cells; Procedure: Total parenteral nutrition |
| Control group for children with SBS | Active comparator | Clinical routine treatment Receives: Procedure: Total parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions
Monitor oxygen, heart rate, temperature, rash, infection, etc
Measured: Within 12 hours after UCB-MNCs infusion
Secondary outcomes (9)
Incidence of complications
Children with BPD: The incidence of various complications such as pneumothorax, necrotizing enterocolitis (NEC), intraventricular hemorrhage (grade 3 and above), persistent pulmonary hypertension (PPHN), retinopathy of prematurity (ROP)
Measured: a year
Imaging test results
Children with HIE: Brain diffusion tensor imaging (DTI) and 18F-Fluorodeoxyglucose positron emission tomography (18F-FDG-PET/CT)
Measured: 2 weeks and 6 months after UCB-MNCs infusion
Electroencephalography (EEG) results
Children with HIE: The frequency of seizures will be measured via EEG. Seizures appear on EEG as a sudden and transient rise in the lower and/or upper borders of amplitude
Measured: 7 days UCB-MNCs infusion
Ventilator supporting time
Ventilator supporting time and oxygen demand will be recorded as important indications for clinical prognosis for children with HIE or BPD
Measured: 1 month after UCB-MNCs infusion
Change of Gross Motor Performance Measure (GMPM)
GMPM is a standardized measurement tool for assessing quality of movement for children with HIE. Higher value means better motor quality
Measured: 1, 3, 6 months after UCB-MNCs infusion
Change of Gross Motor Function Measure (GMFM)
GMFM is a standardized measurement tool for assessing motor function for children with HIE. It consists of lying \& rolling, sitting, crawling \& kneeling, standing, etc. Higher value means better gross motor function
Measured: 1, 3, 6 months after UCB-MNCs infusion
Biomarker of HIE
pNF-H, marker of central nervous system axonal damage
Measured: 7 days after UCB-MNCs infusion
Biomarker of BPD
AGER, marker of lung epithelial cell damage
Measured: 7 days after UCB-MNCs infusion
Inflammatory indicators concentrations
Serum IL-6, IL-8, TNF concentrations will be measured via ELISA for children with HIE, BPD or SBS
Measured: 7 days after UCB-MNCs infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Apr 2022
- Primary completion30 May 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Qilu Stem Cells Engineering Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qilu Children's Hospital of Shandong University
- Responsible party
- Sponsor
- Investigators
- Xiaoying Li, MD, Principal investigator, Qilu Children's Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427642
- Sponsor's protocol ID
- MNCs-2024
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Umbilical Cord Blood-derived Mononuclear Cells in the Treatment of Refractory Neonatal Diseases
- ClinicalTrials.gov ID
- NCT06427642
- Acronym / sponsor ID
- MNCs-2024
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shandong Qilu Stem Cells Engineering Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Qilu Children's Hospital of Shandong University
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental group for children with HIE | Experimental | Biological: Mononuclear cells, Device: Mild hypothermia therapyIntravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient |
| Control group for children with HIE | Active comparator | Device: Mild hypothermia therapyMild hypothermia therapy is given for 72 hours to maintain anal temperature between 33.5°C and 34°C |
| Experimental group for children with BPD | Experimental | Biological: Mononuclear cells, Device: Breathing support techniqueIntravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient |
| Control group for children with BPD | Active comparator | Device: Breathing support techniqueClinical routine treatment |
| Experimental group for children with SBS | Experimental | Biological: Mononuclear cells, Procedure: Total parenteral nutritionIntravenous infusion of UCB-MNCs |
| Control group for children with SBS | Active comparator | Procedure: Total parenteral nutritionClinical routine treatment |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mononuclear cellsUCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation | Biological | Experimental group for children with BPD, Experimental group for children with HIE, Experimental group for children with SBS |
| Mild hypothermia therapyMild hypothermia therapy via hypothermia therapy apparatus | Device | Control group for children with HIE, Experimental group for children with HIE |
| Breathing support techniqueBreathing support via ventilator | Device | Control group for children with BPD, Experimental group for children with BPD |
| Total parenteral nutritionLiquid nutrition injected directly into the bloodstream | Procedure or surgery | Control group for children with SBS, Experimental group for children with SBS |
Primary outcome
Incidence of adverse reactions
Time frame: Within 12 hours after UCB-MNCs infusion
Monitor oxygen, heart rate, temperature, rash, infection, etc
9 secondary outcomes
Incidence of complications
Time frame: a year
Imaging test results
Time frame: 2 weeks and 6 months after UCB-MNCs infusion
Electroencephalography (EEG) results
Time frame: 7 days UCB-MNCs infusion
Ventilator supporting time
Time frame: 1 month after UCB-MNCs infusion
Change of Gross Motor Performance Measure (GMPM)
Time frame: 1, 3, 6 months after UCB-MNCs infusion
Change of Gross Motor Function Measure (GMFM)
Time frame: 1, 3, 6 months after UCB-MNCs infusion
Biomarker of HIE
Time frame: 7 days after UCB-MNCs infusion
Biomarker of BPD
Time frame: 7 days after UCB-MNCs infusion
Inflammatory indicators concentrations
Time frame: 7 days after UCB-MNCs infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoying Li, MD principal investigator
Qilu Children's Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mononuclear cells, Mild hypothermia therapy and Breathing support technique in people with Hypoxic-Ischemic Encephalopathy and Bronchopulmonary Dysplasia, run by Shandong Qilu Stem Cells Engineering Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yujie Han, MD (+86 187 5414 6336, 410358192@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (time frame: Within 12 hours after UCB-MNCs infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.