A Phase 1/2 interventional study of MSC in BPD - Bronchopulmonary Dysplasia, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 36 Weeks and older. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Phase 1/2, Interventional, and Treatment
Among 32 studies in Bronchopulmonary Dysplasia with a site in China — 6 open to participants now, 6 under way, 2 of them phase 3. Bronchopulmonary Dysplasia · China.
Among the 32 studies in Bronchopulmonary Dysplasia with a site in China, this one is the 20th largest by planned enrollment of the 22 interventional ones that give a count, is the only one that started in 2024, is one of 3 in phase 1/2, and was the 28th registered.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
Browse Bronchopulmonary Dysplasia studies →6 of the 32 studies in Bronchopulmonary Dysplasia with a site in China are open now. Recruiting first, the newest first:
International Peace Maternity and Child Health Hospital · Sites in China
Ages 1 days–10 wk · Healthy volunteers
International Peace Maternity and Child Health Hospital · Sites in China
Ages up to 10 wk · Healthy volunteers
Shandong Qilu Stem Cells Engineering Co., Ltd. · Sites in China
Ages 1 days–28 days
Guangdong Women and Children Hospital · Sites in China
Ages 0 wk–28 wk
The Children's Hospital of Zhejiang University School of Medicine · Sites in China
Ages 14 days–28 days
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 58 Bronchopulmonary Dysplasia studies recruiting now, 7 (12%) set no upper age limit and 50 (86%) stop at 75 or younger; 56 take children under 18; 11 take healthy volunteers.
This study: 36 Weeks and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 9 · Phase 3 5 · Phase 4 1
First in 2009; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 is below the median of 66 across 244 interventional studies indexed under Bronchopulmonary Dysplasia.
Median enrollment 69 across the 22 interventional studies, 311 across the 10 observational. Of the 11 that completed or were terminated, 3 (27%) have results posted.
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1 of 32 have an industry lead sponsor. The 10 most frequent:
The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.
The Children's Hospital of Zhejiang University School of Medicine has 2 studies filed under Bronchopulmonary Dysplasia — fewer than ten, so there is no comparison to draw.
2 of the studies in Bronchopulmonary Dysplasia with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06788470The Children's Hospital of Zhejiang University School of MedicineSafety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) in Premature Infants | 2027-08-09 |
| NCT07561125International Peace Maternity and Child Health HospitalEffects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below | 2027-09 |
Among the 32 studies in Bronchopulmonary Dysplasia with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
MSCs (1×10\^7/kg) are administered intratracheally to participators.
Drug: MSC
Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs).
Extubating time after MSC transplantation
Record how long it takes for the participants' tracheal tubes to be removed after MSC transplantation.
Time frame: until 24 months of corrected age
The number of times and total duration of re-intubation after extubating
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.
Time frame: until 24 months of corrected age
Mortality of BPD
Record the number of participants who died from BPD.
Time frame: until 24 months of corrected age
Further assess the severity of BPD by detecting the levels of pro-inflammatory cytokine in alveolar lavage fluid, pulmonary function index and chest radiography.
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.
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.
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.
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.
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.
Time frame: until 24 months of corrected age
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Aug 2027, 36 months after the start.
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The Children's Hospital of Zhejiang University School of Medicine