Actively Recruiting

Phase Not Applicable
Age: 1Day - 28Days
All Genders
NCT06427642

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

Led by Shandong Qilu Stem Cells Engineering Co., Ltd. · Updated on 2024-05-24

120

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

S

Shandong Qilu Stem Cells Engineering Co., Ltd.

Lead Sponsor

Q

Qilu Children's Hospital of Shandong University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Day - 28Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • For children with hypoxic-ischemic encephalopathy (HIE): meet the diagnostic criteria for HIE.
  • For children with bronchopulmonary dysplasia (BPD): preterm infants with gestational age of 25-30 weeks.
  • For children with bronchopulmonary dysplasia (BPD): birth weight between 401 and 1249 grams.
  • For children with bronchopulmonary dysplasia (BPD): assessed risk of BPD greater than 60% based on the NCHD Neonatal Cooperative Network scoring system.
  • For children with short bowel syndrome (SBS): postoperative SBS caused by neonatal necrotizing enterocolitis or digestive tract malformations such as intestinal atresia, anal atresia, or intestinal stenosis.
  • Parents have read the study information, agree to the treatment, and have signed informed consent.
Not Eligible

You will not qualify if you...

  • For children with HIE: unable or unwilling to provide informed consent or unable to comply with trial requirements.
  • For children with BPD: presence of severe anemia, severe intracranial hemorrhage, pulmonary hemorrhage, congenital respiratory malformations (including posterior nostril atresia, tracheoesophageal fistula, cleft palate), complicated congenital heart disease, diaphragmatic hernia, shock, or other serious comorbidities.
  • For children with BPD: presence of congenital inherited metabolic diseases, endocrine diseases, severe congenital malformations, or other diseases that affect lung development.
  • For children with BPD: 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qilu Children's Hospital of Shandong University

Jinan, Shandong, China

Actively Recruiting

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Research Team

Y

Yujie Han, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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