Bronchopulmonary DysplasiaPhase 1/2IUMTBNCT03645525
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
A Phase 1/2 study testing Human Umbilical Cord-derived Mesenchymal stem cell in people with Bronchopulmonary Dysplasia, run by Children's Hospital of Fudan University at 3 sites in China.
Trial summary
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD. Read more about this study
- Who is it for?
- Ages 2 to 3 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Human Umbilical Cord-derived Mesenchymal stem cell
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesChina
- Study dates
- 1 Dec 2019to 1 Apr 2023
- Phase
- Phase 1/2
- 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 2 to 3 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age
- Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age
Who cannot join
- Patients with severe congenital diseases
- Patients with IVH more than 3 grade
- Patients with severe sepsis
- Patients with active pulmonary hemorrhage
Trial locations and contacts
3 sites in 1 country.
China3 sites
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 201204
About this study
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
Read the detailed description
Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking.
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Human Umbilical Cord-derived Mesenchymal stem cell, placebo
- Keywords
- Bronchopulmonary Dysplasia, 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.
Human Umbilical Cord-derived Mesenchymal stem cellDrug
The Human Umbilical Cord-derived Mesenchymal stem cells suspension (2×10^7/kg per KG of the infant 's weight ) will be instilled once through a catheter into the infant' s endotracheal tube
placeboDrug
saline
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell | Experimental | Human Umbilical Cord-derived Mesenchymal stem cell in the saline Receives: Drug: Human Umbilical Cord-derived Mesenchymal stem cell |
| placebo | Placebo comparator | saline without mesenchymal stem cell Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen requirement 3 days after transplantation
Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %
Measured: 3 days
Secondary outcomes (12)
Oxygen requirement 7 days after transplantation
Temporal profiles of the fraction of inspiration oxygen 7 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %
Measured: 7 days
Duration of ventilator dependence
The duration from transplantation to weaning from ventilator
Measured: up to 36 weeks PMA
Incidence of severe BPD
percentage of participants with severe BPD ,diagnosed at 36 weeks PMA
Measured: up to 36 weeks PMA
Survival rate
Percentage of participants who survived up to 36 weeks PMA
Measured: up to 36 weeks PMA
Temperature
Temporal profiles of temperature
Measured: 3 days
Heart rate
Temporal profiles of heart rate
Measured: 3 days
Respiratory rate
Temporal profiles of respiratory rate
Measured: 3 days
Duration of CPAP treatment
Duration of CPAP treatment
Measured: up to 36 weeks PMA
Percentage of participants treated with steroids for weaning from ventilator
Percentage of participants treated with steroids for weaning from ventilator
Measured: up to 36 weeks PMA
Growth velocity (Z-score)
percentile for body weight, height, and head circumference
Measured: up to 36 weeks PMA
bronohoalveolar lavage (BAL) cytokine level
BAL were collected 7 days after transplantation for cytokine (IL-6，IL-8，TNF-α，TGF-β,VEGF,HGF) level examination, measured in pg/ml
Measured: 7 days
The severity of BPD in X-ray patterns
A chest X-ray was performed in participants before and after transplantation. The severity of BPD (mild，moderate，severe) was assessed by a single radiographic doctor who is blind about randomization
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Dec 2019
- Primary completion30 Oct 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Why it stopped: The certification of cell-based treatment in the settings need to be updated.
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.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Chao, PhD,MD, Study director, Chiledren's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645525
- Sponsor's protocol ID
- EKYYIUMTB
- Acronym
- IUMTB
- Status last verified
- Dec 2023
- First submitted
- 16 Aug 2018
- Last updated
- 29 Dec 2023
- Results posted
- No
- 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
- ClinicalTrials.gov ID
- NCT03645525
- Acronym / sponsor ID
- IUMTB / EKYYIUMTB
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary Dysplasia, Mesenchymal stem cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The certification of cell-based treatment in the settings need to be updated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 24 Aug 2018 (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.
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
Detailed description
Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking.
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell | Experimental | Drug: Human Umbilical Cord-derived Mesenchymal stem cellHuman Umbilical Cord-derived Mesenchymal stem cell in the saline |
| placebo | Placebo comparator | Drug: placebosaline without mesenchymal stem cell |
Who may qualify
- Ages
- 2 to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age
- Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age
Key exclusion criteria (4 listed)
- Patients with severe congenital diseases
- Patients with IVH more than 3 grade
- Patients with severe sepsis
- Patients with active pulmonary hemorrhage
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 |
|---|---|---|
| Human Umbilical Cord-derived Mesenchymal stem cellThe Human Umbilical Cord-derived Mesenchymal stem cells suspension (2×10^7/kg per KG of the infant 's weight ) will be instilled once through a catheter into the infant' s endotracheal tube | Drug | Mesenchymal stem cell |
| placebosaline | Drug | placebo |
Primary outcome
Oxygen requirement 3 days after transplantation
Time frame: 3 days
Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %
12 secondary outcomes
Oxygen requirement 7 days after transplantation
Time frame: 7 days
Duration of ventilator dependence
Time frame: up to 36 weeks PMA
Incidence of severe BPD
Time frame: up to 36 weeks PMA
Survival rate
Time frame: up to 36 weeks PMA
Temperature
Time frame: 3 days
Heart rate
Time frame: 3 days
Respiratory rate
Time frame: 3 days
Duration of CPAP treatment
Time frame: up to 36 weeks PMA
Percentage of participants treated with steroids for weaning from ventilator
Time frame: up to 36 weeks PMA
Growth velocity (Z-score)
Time frame: up to 36 weeks PMA
bronohoalveolar lavage (BAL) cytokine level
Time frame: 7 days
The severity of BPD in X-ray patterns
Time frame: 7 days
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 29 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Chen Chao, PhD,MD study director
Chiledren's Hospital of Fudan University
3 sites 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 Human Umbilical Cord-derived Mesenchymal stem cell in people with Bronchopulmonary Dysplasia, run by Children's Hospital of Fudan University at 3 sites 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 2 inclusion and 4 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 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
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?
Oxygen requirement 3 days after transplantation (time frame: 3 days). 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 29 Dec 2023.