Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) in Premature Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MSC.
- Who it may be relevant to
- Registry conditions: BPD - Bronchopulmonary Dysplasia. Basic parameters: from 36 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell Transplantation in the Treatment of Bronchopulmonary Dysplasia in Premature Infants
Overview
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.
Interventions
- Drug MSC
Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs).
Primary outcome measures
- Extubating time after MSC transplantation [Time frame: until 24 months of corrected age]
- The number of times and total duration of re-intubation after extubating [Time frame: until 24 months of corrected age]
- Mortality of BPD [Time frame: until 24 months of corrected age]
Secondary outcome measures (3)
- 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]
- 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]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Children's Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT06788470 · 2019-SC-001