BPD - Bronchopulmonary DysplasiaPhase 1/2MSC，BPDNCT06788470
Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) in Premature Infants
A Phase 1/2 study testing MSC in people with BPD - Bronchopulmonary Dysplasia, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 36 weeks and older
- Conditions the study is for
- BPD - Bronchopulmonary Dysplasia
- What is being tested?
- MSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2024to 9 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 36 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Ruoqiong Huang, Postdoc, 0571-86670704, huangruoqiong@zju.edu.cn
Qiang Shu, MD
About this study
Official title: Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell Transplantation in the Treatment of Bronchopulmonary Dysplasia 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.
- Conditions
- BPD - Bronchopulmonary Dysplasia
- Being tested
- MSC
- Keywords
- Bronchopulmonary dysplasia (BPD), Mesenchymal stem cells (MSCs), Premature infants
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCDrug
Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs).
| Study group | Role | What they receive |
|---|---|---|
| MSC transplantation | Experimental | MSCs (1×10^7/kg) are administered intratracheally to participators. Receives: Drug: MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubating time after MSC transplantation
Record how long it takes for the participants' tracheal tubes to be removed after MSC transplantation.
Measured: 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.
Measured: until 24 months of corrected age
Mortality of BPD
Record the number of participants who died from BPD.
Measured: until 24 months of corrected age
Secondary outcomes (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.
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.
Measured: 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.
Measured: 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.
Measured: until 24 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start9 Aug 2024
- Primary completion9 Aug 2027 (estimated)
- Study completion9 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPD - Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs) in premature infants with bronchopulmonary dysplasia (BPD).
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Qiang, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788470
- Sponsor's protocol ID
- 2019-SC-001
- Acronym
- MSC，BPD
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell Transplantation in the Treatment of Bronchopulmonary Dysplasia in Premature Infants
- ClinicalTrials.gov ID
- NCT06788470
- Acronym / sponsor ID
- MSC，BPD / 2019-SC-001
- Conditions
- BPD - Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary dysplasia (BPD), Mesenchymal stem cells (MSCs), Premature infants
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 9 Aug 2027 (estimated)
- Study completion
- 9 Aug 2027 (estimated)
- First posted
- 23 Jan 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs) in premature infants with bronchopulmonary dysplasia (BPD).
| Arm | Type | Receives |
|---|---|---|
| MSC transplantation | Experimental | Drug: MSCMSCs (1×10^7/kg) are administered intratracheally to participators. |
Who may qualify
- Ages
- 36 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| MSCIntratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs). | Drug | MSC transplantation |
Primary outcome
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.
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.
Mortality of BPD
Time frame: until 24 months of corrected age
Record the number of participants who died from BPD.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSC in people with BPD - Bronchopulmonary Dysplasia, run by The Children's Hospital of Zhejiang University School of Medicine 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Jan 2025. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaoqin Hu, MD (0571-86670704, huyaoqin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubating time after MSC transplantation (time frame: until 24 months of corrected age). The study lists 3 primary outcomes in all. 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 23 Jan 2025.