Safety IssuesPhase 1NCT03683953
The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
A Phase 1 study testing mesenchymal stem cells therapy and 0.9% sodium chloride in people with Safety Issues and Effect of Drugs, run by Guangdong Women and Children Hospital.
Trial summary
To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD Read more about this study
- Who is it for?
- Ages 28 to 37 weeks
- Conditions the study is for
- Safety Issues, Effect of Drugs
- What is being tested?
- mesenchymal stem cells therapy and 0.9% sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2018to 1 Jul 2020
- Phase
- 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 28 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- twenty-eight weeks to thirty-seven weeks prematures who need ventilaton for 14 days after birth, and the oxygen concentration is more than 30%
Who cannot join
- Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
Trial locations and contacts
No sites are listed yet.
About this study
To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD
Read the detailed description
This is a Phase 1 clinical trial that constitues two points cohorts with 100 participants per cohort who will receive instillation dose of mesenchymal stem cells-25 million cells/kg,with ventilation after 14 days.And the placebol will be 0.9% sodium choride. The investigator will proceed the groups during the same period.
- Deographic Data and Baseline charateristics of the studied groups were collected: Gestational age (weeks) Birth weight (g) gender Cesarean section delivery Antenatal steroids Prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes
- mesenchymal stem cels dose is 25 million cells/kg
- Assessment the incidence of BPD after instillation of Mesenchymal stem cells
- the adverse after instillation of Mesenchymal stem cells
- Conditions
- Safety Issues, Effect of Drugs
- Being tested
- mesenchymal stem cells therapy, 0.9% sodium chloride
- Keywords
- mesenchymal stem cells, safety, effect, BPD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cells therapyOther
mesenchymal stem cells treatement of BPD for safety and effect evaluation0.9% sodium chloride incontrol group
0.9% sodium chlorideDrug
0.9% sodium chloride in control group
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.9% sodium chloride intratracheal instillate on 14 days after birth Receives: Drug: 0.9% sodium chloride |
| mesenchymal stem cells | Experimental | mesenchymal stem cells intratracheal instillate on 14 days after birth ,dose is 25 million cells/kg Receives: Other: mesenchymal stem cells therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with BPD after instillation mesenchymal stem cells
incidence of BPD
Measured: up to 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start29 Sep 2018 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yangjie, Guangdong Women and Children Hospital
- Investigators
- Jie Yang, PHD, Principal investigator, Guangzhou, Guangdong,China，511442
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683953
- Sponsor's protocol ID
- Guangdong W CH
- Status last verified
- Jul 2018
- First submitted
- 24 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mezey E, Nemeth K. Mesenchymal stem cells and infectious diseases: Smarter than drugs. Immunol Lett. 2015 Dec;168(2):208-14. doi: 10.1016/j.imlet.2015.05.020. Epub 2015 Jun 4.
PubMed 26051681
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT03683953
- Acronym / sponsor ID
- Guangdong W CH
- Conditions
- Safety Issues, Effect of Drugs
- Keywords
- mesenchymal stem cells, safety, effect, BPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 29 Sep 2018 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 25 Sep 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.
To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD
Detailed description
This is a Phase 1 clinical trial that constitues two points cohorts with 100 participants per cohort who will receive instillation dose of mesenchymal stem cells-25 million cells/kg,with ventilation after 14 days.And the placebol will be 0.9% sodium choride. The investigator will proceed the groups during the same period.
- Deographic Data and Baseline charateristics of the studied groups were collected: Gestational age (weeks) Birth weight (g) gender Cesarean section delivery Antenatal steroids Prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes
- mesenchymal stem cels dose is 25 million cells/kg
- Assessment the incidence of BPD after instillation of Mesenchymal stem cells
- the adverse after instillation of Mesenchymal stem cells
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0.9% sodium chloride0.9% sodium chloride intratracheal instillate on 14 days after birth |
| mesenchymal stem cells | Experimental | Other: mesenchymal stem cells therapymesenchymal stem cells intratracheal instillate on 14 days after birth ,dose is 25 million cells/kg |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- twenty-eight weeks to thirty-seven weeks prematures who need ventilaton for 14 days after birth, and the oxygen concentration is more than 30%
Key exclusion criteria (1 listed)
- Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
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 |
|---|---|---|
| mesenchymal stem cells therapymesenchymal stem cells treatement of BPD for safety and effect evaluation0.9% sodium chloride incontrol group | Other | mesenchymal stem cells |
| 0.9% sodium chloride0.9% sodium chloride in control group | Drug | Placebo |
Primary outcome
number of patients with BPD after instillation mesenchymal stem cells
Time frame: up to 28 days after birth
incidence of BPD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Results publication: PubMed 26051681Mezey E, Nemeth K. Mesenchymal stem cells and infectious diseases: Smarter than drugs. Immunol Lett. 2015 Dec;168(2):208-14. doi: 10.1016/j.imlet.2015.05.020. Epub 2015 Jun 4.
- 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.
Jie Yang, PHD principal investigator
Guangzhou, Guangdong,China，511442
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mesenchymal stem cells therapy and 0.9% sodium chloride in people with Safety Issues and Effect of Drugs, run by Guangdong Women and Children Hospital.
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: status not confirmed, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuxiao Ren, MD (+8613538984634 ext. +86, renzhx1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with BPD after instillation mesenchymal stem cells (time frame: up to 28 days after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683953, which also lists 1 linked publication.
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 25 Sep 2018.