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NCT Number: NCT06788470

Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) in Premature Infants

Bronchopulmonary dysplasia (BPD) is a chronic lung disease, which is a major complication of very low and ultra-low preterm infants. Moderate and severe BPD survivors are prone to adverse outcomes such as impaired lung function, childhood exercise intolerance, and neurodevelopmental retardation in the long term, which seriously affects their quality of life and brings a heavy burden to society and families. However, the pathogenesis of BPD is complex, including pulmonary vascular dysplasia, lung inflammation, and impaired alveolar development. There is currently no specific clinical drug to cure BPD. Mesenchymal stem cells (MSCs) are a kind of multipotent stem cells that exist in almost all organs and tissues of individuals. MSCs have the properties including self-renewal, multi-directional differentiation, and immunosuppressive and anti-inflammatory abilities. Preclinical studies have shown that MSCs can alleviate BPD by improving alveolar and pulmonary vascular development, and reducing pulmonary fibrosis. Several phase I clinical studies have demonstrated that intratracheal transplantation of human umbilical cord blood-derived mesenchymal stem cells for children with BPD is safe and feasible.

This study aims to further evaluate the safety and efficacy of umbilical cord-derived mesenchymal stem cell transplantation in the treatment of severe BPD in premature infants, in the hope of increasing the survival rate and improving the prognosis of severe BPD.

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Key information

Conditions

BPD - Bronchopulmonary Dysplasia Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

36 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location status: Recruiting

Location contact

Qiang Shu, MD

PRINCIPAL_INVESTIGATOR

Ruoqiong Huang, Postdoc

CONTACT

[email protected]

0571-86670704

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 23-29 weeks of gestation, birth weight 500-1500g;
  • For patients with no improvement or aggravation of lung condition after DART hormone therapy, and positive pressure ventilation by tracheal intubation is still required at a correct gestational age of 36 weeks.
  • Children with severe BPD after early use of PS
  • Parents agree to participate in clinical trials.

Exclusion criteria

  • Premature infants not suitable for the given gestational age;
  • Other congenital structural malformations of trachea, bronchus and lungs;
  • Complicated with severe congenital heart disease;
  • Complicated with Periventricular Leukomalacia (PVL);
  • Complicated with intraventricular hemorrhage (IVH) above level 3;
  • Septic shock or positive blood culture;
  • Acute pulmonary hemorrhage;
  • Intracranial and extracranial diseases affecting respiratory rate and rhythm.

Treatment and study plan

MSC

Drug

Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs).

Primary outcomes

  1. Extubating time after MSC transplantation

    Time frame: until 24 months of corrected age

    Record how long it takes for the participants' tracheal tubes to be removed after MSC transplantation.

  2. The number of times and total duration of re-intubation after extubating

    Time frame: until 24 months of corrected age

    If the participants' tracheal tubes are removed after MSC transplantation, record the number of times and total duration of tracheal re-intubation until discharge and 24 months of corrected age.

  3. Mortality of BPD

    Time frame: until 24 months of corrected age

    Record the number of participants who died from BPD.

Secondary outcomes

  1. Further assess the severity of BPD by detecting the levels of pro-inflammatory cytokine in alveolar lavage fluid, pulmonary function index and chest radiography.

    Time frame: until 24 months of corrected age

    The levels of pro-inflammatory cytokine (IL-6, IL-8, TNF-α, IL-1β, IL-10, MMP-9, TGF-β) in alveolar lavage fluid are examined via ELISA kits before and at 7 days after MSC transplantation. Record the pulmonary function index including FiO2, PaO2, VT, PEEP. Participants perform the chest radiography examination before and at 24 hours, 3 Days, 7days and 1month after MSC transplantation. The severity of BPD will be further assessed by above indicators.

  2. Short-term safety assessment of MSC transplantation by whether anaphylaxis and severe infection are observed within 24 hours after MSC transplantation.

    Time frame: within 24 hours after MSC transplantation

    Observed and record whether participants experience anaphylaxis including rash and anaphylactic shock within 24 hours after MSC transplantation. Also, record whether participants experience severe infection including hyperpyrexia, aggravated pulmonary inflammation and worse pulmonary function within 24 hours after MSC transplantation.

  3. long-term safety assessment of MSC transplantation by whether intraventricular hemorrhage, periventricular leukomalacia, neurodevelopmental problems and tumor formation are observed after MSC transplantation until 24 months of corrected age.

    Time frame: until 24 months of corrected age

    Participants perform the cranial ultrasound to assess whether intraventricular hemorrhage and periventricular leukomalacia occur. Cranial MRI and Bayley Scale for Infant Development (BSID) are performed to assess neurodevelopment. Ultrasound and MRI examinations are performed to assess tumor formation after MSC transplantation until 24 months of corrected age.

Study contacts

Contact information is provided by the study sponsor or research team.

Yaoqin Hu, MD

CONTACT

[email protected]

0571-86670704

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell Transplantation in the Treatment of Bronchopulmonary Dysplasia in Premature Infants

Acronym: MSC，BPD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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