Safety IssuesPhase 2NCT04311476
Autologous Cord Blood Cells for Prevention of BPD in Preterm
A Phase 2 study testing Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy and 0.9% Sodiun Chloride in people with Safety Issues and BPD - Bronchopulmonary Dysplasia, run by yangjie at 1 site in China.
Trial summary
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates Read more about this study
- Who is it for?
- Ages 28 to 32 weeks
- Conditions the study is for
- Safety Issues, BPD - Bronchopulmonary Dysplasia, Neonatal Death
- What is being tested?
- Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy and 0.9% Sodiun Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Jan 2020
- Phase
- Phase 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 28 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born in the study hospital;
- singleton birth;
- less than 32 weeks GA
- Without congenital malformations or known chromosomal aberrations;
- Without clinical chorioamnionitis;
- the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus;
- consents were obtained from their parents or guardians;
- the umbilical cord blood cells after processing were available.
Who cannot join
- birth-weight was less than the third percentile for gestational age according to Fenton curve,
- if they had severe perinatal asphyxia (defined as an Apgarscore of 0-3 for more than 5 minutes, a cord blood pH of less than 7.00, or both) and were expected to die shortly after birth.
Trial locations and contacts
1 site in 1 country.
About this study
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
Read the detailed description
We did a randomized, double-blind, placebo-controlled trial to assess effect of one intravenous dose of cord blood MNCs compared with placebo in reducing incidence of BPD in very preterm neonates.We enrolled preterm neonates less than 32 weeks of GA at neonatal intensive care units (NICUs) in Guangdong Women and Children Hospital within the first 24 postnatal hours. Patients were randomly assigned by 1:1 to receive either (5×107cells/kg ACBMNC or normal saline intravenously within 24 hours after birth according to a computer-generated schedule. The primary endpoint was efficacy at 36 GA or discharge home and all analyses were done by intention to prevent.MNCs viability was also tested before transfusion
- Being tested
- Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy, 0.9% Sodiun Chloride
- Keywords
- ACBMNC, very premature infants, BPD
- Medical subject headings
- Bronchopulmonary Dysplasia, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Umbilical Cord Blood Mononuclear Cells infusion TherapyOther
Also called Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
0.9% Sodiun ChlorideDrug
0.9% Sodiun Chloride in control group
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.9% sodium chloride infusion within 24 hours after birth Receives: Drug: 0.9% Sodiun Chloride |
| ACBMNC | Experimental | Autologous Umbilical Cord Blood Mononuclear Cells intravenously within 24 hours after birth,dose is 5×107cells/kg , Receives: Other: Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients without bronchopulmonary dysplasia
bronchopulmonary dysplasia incidence
Measured: at 36 weeks of postmenstrual age or discharge home, whichever came first
Secondary outcomes (1)
number of patients who died， severe bronchopulmonary dysplasia
mortaliity rate
Measured: at 36 weeks of postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Jul 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- yangjie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yangjie, Guangdong Women and Children Hospital
- Investigators
- Jie Yang, PHD, Principal investigator, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311476
- Sponsor's protocol ID
- Guangdong WC H
- Status last verified
- May 2020
- First submitted
- 15 Mar 2020
- Last updated
- 2 Jun 2020
- 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 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cord Blood Cells for Prevention of BPD in Preterm
- ClinicalTrials.gov ID
- NCT04311476
- Acronym / sponsor ID
- Guangdong WC H
- Keywords
- ACBMNC, very premature infants, BPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- yangjieUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 17 Mar 2020 (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 of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
Detailed description
We did a randomized, double-blind, placebo-controlled trial to assess effect of one intravenous dose of cord blood MNCs compared with placebo in reducing incidence of BPD in very preterm neonates.We enrolled preterm neonates less than 32 weeks of GA at neonatal intensive care units (NICUs) in Guangdong Women and Children Hospital within the first 24 postnatal hours. Patients were randomly assigned by 1:1 to receive either (5×107cells/kg ACBMNC or normal saline intravenously within 24 hours after birth according to a computer-generated schedule. The primary endpoint was efficacy at 36 GA or discharge home and all analyses were done by intention to prevent.MNCs viability was also tested before transfusion
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0.9% Sodiun Chloride0.9% sodium chloride infusion within 24 hours after birth |
| ACBMNC | Experimental | Other: Autologous Umbilical Cord Blood Mononuclear Cells infusion TherapyAutologous Umbilical Cord Blood Mononuclear Cells intravenously within 24 hours after birth,dose is 5×107cells/kg , |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- born in the study hospital;
- singleton birth;
- less than 32 weeks GA
- Without congenital malformations or known chromosomal aberrations;
- Without clinical chorioamnionitis;
Key exclusion criteria (2 listed)
- birth-weight was less than the third percentile for gestational age according to Fenton curve,
- if they had severe perinatal asphyxia (defined as an Apgarscore of 0-3 for more than 5 minutes, a cord blood pH of less than 7.00, or both) and were expected to die shortly after birth.
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 |
|---|---|---|
| Autologous Umbilical Cord Blood Mononuclear Cells infusion TherapyAlso: Autologous Umbilical Cord Blood Mononuclear Cells TherapyEvaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates | Other | ACBMNC |
| 0.9% Sodiun Chloride0.9% Sodiun Chloride in control group | Drug | Placebo |
Primary outcome
number of patients without bronchopulmonary dysplasia
Time frame: at 36 weeks of postmenstrual age or discharge home, whichever came first
bronchopulmonary dysplasia incidence
1 secondary outcome
number of patients who died， severe bronchopulmonary dysplasia
Time frame: at 36 weeks of postmenstrual age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Safety Issues
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruitingPhase 1
Phase 1 Study to Evaluate RG002C0106 Injection in Healthy Participants
Safety Issues
Enrolling by invitation
Pediatric Trauma Centers RE-AIM at Gun Safety
Firearm Injury, Safety Issues
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
Active, not recruitingPhase 1/2
Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis
Safety Issues, Pain
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
Guangdong Women and Children Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy and 0.9% Sodiun Chloride in people with Safety Issues and BPD - Bronchopulmonary Dysplasia, run by yangjie 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jun 2020. 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. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of patients without bronchopulmonary dysplasia (time frame: at 36 weeks of postmenstrual age or discharge home, whichever came first). 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 2 Jun 2020.