Bronchopulmonary DysplasiaEarly Phase 1NCT03378063
Stem Cells for Bronchopulmonary Dysplasia
A Early Phase 1 study testing transplantation of mesenchymal stem cell and no transplantation of mesenchymal stem cell in people with Bronchopulmonary Dysplasia, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the lack of effective measures to prevent or ameliorate this common and serious disorder. BPD remains a major cause of mortality and lifelong morbidity in preterm infants Read more about this study
- Who is it for?
- Ages 1 month to 3 months
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- transplantation of mesenchymal stem cell and no transplantation of mesenchymal stem cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 30 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 1 month to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed with BPD
Who cannot join
- parents' rejection
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study
Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the lack of effective measures to prevent or ameliorate this common and serious disorder. BPD remains a major cause of mortality and lifelong morbidity in preterm infants
Read the detailed description
Several studies have shown that transplantation of mesenchymal stem cells (MSCs) in immunocompetent animals attenuates lung injury, such as impaired alveolarization, inflammatory response, increased apoptosis, and fibrosis. Human umbilical cord blood (hUCB) is considered a better source of MSCs because of their ready availability and greater proliferative capacity and less antigenicity than other cell types.
transplantation of hUCB-derived MSCs should be effective in treating BPD. The safety and efficacy of MSC transplantation for prevention of BPD has not been tested previously, however.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- transplantation of mesenchymal stem cell, no transplantation of mesenchymal stem cell
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transplantation of mesenchymal stem cellDrug
allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants
no transplantation of mesenchymal stem cellDrug
MSC transplantation will be not given to preterm infants
| Study group | Role | What they receive |
|---|---|---|
| transplantation of mesenchymal stem cell | Experimental | transplantation of mesenchymal stem cell will be given to the infants with BPD. Receives: Drug: transplantation of mesenchymal stem cell |
| no transplantation of mesenchymal stem cell | Active comparator | transplantation of mesenchymal stem cell will be not given to the infants with BPD. Receives: Drug: no transplantation of mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
the infant is dead due to lung disease
Measured: within two years
Secondary outcomes (1)
Bayley Scales of Infant Development
scores of Bayley Scales of Infant Development at 2 months old and 2 years old
Measured: 30 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Nov 2017
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Why it stopped: no stell cell accessed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University, Chongqing Maternal and Child Health Hospital
- Responsible party
- Principal investigator, Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378063
- Sponsor's protocol ID
- stem cell for BPD
- Status last verified
- Feb 2021
- First submitted
- 6 Dec 2017
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study
- ClinicalTrials.gov ID
- NCT03378063
- Acronym / sponsor ID
- stem cell for BPD
- Conditions
- Bronchopulmonary Dysplasia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no stell cell accessed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University, Chongqing Maternal and Child Health Hospital
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 19 Dec 2017 (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.
Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the lack of effective measures to prevent or ameliorate this common and serious disorder. BPD remains a major cause of mortality and lifelong morbidity in preterm infants
Detailed description
Several studies have shown that transplantation of mesenchymal stem cells (MSCs) in immunocompetent animals attenuates lung injury, such as impaired alveolarization, inflammatory response, increased apoptosis, and fibrosis. Human umbilical cord blood (hUCB) is considered a better source of MSCs because of their ready availability and greater proliferative capacity and less antigenicity than other cell types.
transplantation of hUCB-derived MSCs should be effective in treating BPD. The safety and efficacy of MSC transplantation for prevention of BPD has not been tested previously, however.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transplantation of mesenchymal stem cell | Experimental | Drug: transplantation of mesenchymal stem celltransplantation of mesenchymal stem cell will be given to the infants with BPD. |
| no transplantation of mesenchymal stem cell | Active comparator | Drug: no transplantation of mesenchymal stem celltransplantation of mesenchymal stem cell will be not given to the infants with BPD. |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- diagnosed with BPD
Key exclusion criteria (1 listed)
- parents' rejection
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 |
|---|---|---|
| transplantation of mesenchymal stem cellallogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants | Drug | transplantation of mesenchymal stem cell |
| no transplantation of mesenchymal stem cellMSC transplantation will be not given to preterm infants | Drug | no transplantation of mesenchymal stem cell |
Primary outcome
death
Time frame: within two years
the infant is dead due to lung disease
1 secondary outcome
Bayley Scales of Infant Development
Time frame: 30 months after birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing transplantation of mesenchymal stem cell and no transplantation of mesenchymal stem cell in people with Bronchopulmonary Dysplasia, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 May 2023. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: within two years). 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 1 May 2023.