Safety IssuesPhase 1NCT03053076
Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates
A Phase 1 study testing Autologous Umbilical Cord Blood Mononuclear Cells Therapy and 0.9% Sodium Chloride in people with Safety Issues and Effect of Drugs, run by Guangdong Women and Children Hospital at 1 site in China.
Trial summary
To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants Read more about this study
- Who is it for?
- Ages 28 to 37 weeks
- Conditions the study is for
- Safety Issues, Effect of Drugs, Neonatal Death
- What is being tested?
- Autologous Umbilical Cord Blood Mononuclear Cells Therapy and 0.9% Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2017to 15 May 2017
- 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
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
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jie Yang
Guangzhou, Guangdong, 511442
Jie Yang, PHD, 39151777 ext. 020, jasjie_yang@163.com
About this study
To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants
Read the detailed description
This is a Phase 1 clinical trial that constitutes two time points cohorts with 100 participants per cohort who will receive intravenous doses of Autologous Umbilical Cord Blood Mononuclear Cells --25 million cells/kg, 48 hours after birth. And the placebo will be 0.9% sodium chloride.The investigator will proceed the groups during the same period.
- Demographic Data and Baseline Characteristics 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
- Thrombocytopenia before intervention
- CRP before intervention (mg/L)
- TNF-α(tumor necrosis factor α ) before intervention (pg/mL)
- Assessment of clinical condition in the course by measurement of arterial blood pressure, heart and respiratory rates and skin temperature was recorded continuously
- Autologous cord blood mononuclear cells doses is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h，and with same volume of 0.9% sodium chloride as placebo.
- The following are monitored at 3、7、14、21 days after birth:
- mortality, incidence of sepsis, neonatal respiratory distress syndrome (NRDS), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH), Hypoxic Ischemic Encephalopathy (HIE), anaemia, thrombocytopenia, neutrophil,TBNK cells subgroup, before hospital discharge.
- Long-term follow up: in 1m, 3m, 6m,1y: neurodevelopment [Bayley Scales of Infant], asthma, anemia and physique growth.
- Conditions
- Safety Issues, Effect of Drugs, Neonatal Death
- Being tested
- Autologous Umbilical Cord Blood Mononuclear Cells Therapy, 0.9% Sodium Chloride
- Keywords
- cord blood mononuclear cells, safety, effect, neonates
- Medical subject headings
- 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 TherapyOther
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for safety and effect evaluation
0.9% Sodium ChlorideDrug
0.9% Sodium Chloride in control group
| Study group | Role | What they receive |
|---|---|---|
| Placebo1 | Placebo comparator | 0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h， 8-12h， Receives: Drug: 0.9% Sodium Chloride |
| CBMNC | Experimental | Autologous Umbilical Cord Blood Mononuclear Cells Therapy 48 hours after birth ,dose is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h， Receives: Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who died
mortality rate
Measured: up tp 21 days after birth
Secondary outcomes (1)
number of patients with neurodevelopmental disorder assessed by Bayley Score
Long term follow up: in 1 month, 3 months, 6 months, and 1 year: neuro-development
Measured: up to 1 month, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start10 Feb 2017
- Primary completion15 May 2017 (estimated)
- Study completion15 May 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- 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, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053076
- Sponsor's protocol ID
- GuangdongWCH
- Status last verified
- Apr 2017
- First submitted
- 10 Feb 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ballen KK, Gluckman E, Broxmeyer HE. Umbilical cord blood transplantation: the first 25 years and beyond. Blood. 2013 Jul 25;122(4):491-8. doi: 10.1182/blood-2013-02-453175. Epub 2013 May 14.
PubMed 23673863Ren Z, Fang X, Zhang Q, Mai YG, Tang XY, Wang QQ, Lai CH, Mo WH, Dai YH, Meng Q, Wu J, Ao ZZ, Jiang HQ, Yang Y, Qu LH, Deng CB, Wei W, Li Y, Wang QI, Yang J. Use of Autologous Cord Blood Mononuclear Cells Infusion for the Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: A Study Protocol for a Placebo-Controlled Randomized Multicenter Trial [NCT03053076]. Front Pediatr. 2020 Apr 2;8:136. doi: 10.3389/fped.2020.00136. eCollection 2020.
PubMed 32300579
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates
- ClinicalTrials.gov ID
- NCT03053076
- Acronym / sponsor ID
- GuangdongWCH
- Conditions
- Safety Issues, Effect of Drugs, Neonatal Death
- Keywords
- cord blood mononuclear cells, safety, effect, neonates
- 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
- 10 Feb 2017 (actual)
- Primary completion
- 15 May 2017 (estimated)
- Study completion
- 15 May 2017 (estimated)
- First posted
- 14 Feb 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.
To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants
Detailed description
This is a Phase 1 clinical trial that constitutes two time points cohorts with 100 participants per cohort who will receive intravenous doses of Autologous Umbilical Cord Blood Mononuclear Cells --25 million cells/kg, 48 hours after birth. And the placebo will be 0.9% sodium chloride.The investigator will proceed the groups during the same period.
- Demographic Data and Baseline Characteristics 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
- Thrombocytopenia before intervention
- CRP before intervention (mg/L)
- TNF-α(tumor necrosis factor α ) before intervention (pg/mL)
- Assessment of clinical condition in the course by measurement of arterial blood pressure, heart and respiratory rates and skin temperature was recorded continuously
- Autologous cord blood mononuclear cells doses is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h，and with same volume of 0.9% sodium chloride as placebo.
- The following are monitored at 3、7、14、21 days after birth:
- mortality, incidence of sepsis, neonatal respiratory distress syndrome (NRDS), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH), Hypoxic Ischemic Encephalopathy (HIE), anaemia, thrombocytopenia, neutrophil,TBNK cells subgroup, before hospital discharge.
- Long-term follow up: in 1m, 3m, 6m,1y: neurodevelopment [Bayley Scales of Infant], asthma, anemia and physique growth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo1 | Placebo comparator | Drug: 0.9% Sodium Chloride0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h， 8-12h， |
| CBMNC | Experimental | Other: Autologous Umbilical Cord Blood Mononuclear Cells TherapyAutologous Umbilical Cord Blood Mononuclear Cells Therapy 48 hours after birth ,dose is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h， |
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
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 |
|---|---|---|
| Autologous Umbilical Cord Blood Mononuclear Cells TherapyAutologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for safety and effect evaluation | Other | CBMNC |
| 0.9% Sodium Chloride0.9% Sodium Chloride in control group | Drug | Placebo1 |
Primary outcome
number of patients who died
Time frame: up tp 21 days after birth
mortality rate
1 secondary outcome
number of patients with neurodevelopmental disorder assessed by Bayley Score
Time frame: up to 1 month, 3 months, 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Results publication: PubMed 23673863Ballen KK, Gluckman E, Broxmeyer HE. Umbilical cord blood transplantation: the first 25 years and beyond. Blood. 2013 Jul 25;122(4):491-8. doi: 10.1182/blood-2013-02-453175. Epub 2013 May 14.
- Derived from this study: PubMed 32300579Ren Z, Fang X, Zhang Q, Mai YG, Tang XY, Wang QQ, Lai CH, Mo WH, Dai YH, Meng Q, Wu J, Ao ZZ, Jiang HQ, Yang Y, Qu LH, Deng CB, Wei W, Li Y, Wang QI, Yang J. Use of Autologous Cord Blood Mononuclear Cells Infusion for the Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: A Study Protocol for a Placebo-Controlled Randomized Multicenter Trial [NCT03053076]. Front Pediatr. 2020 Apr 2;8:136. doi: 10.3389/fped.2020.00136. eCollection 2020.
- 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
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 1 study testing Autologous Umbilical Cord Blood Mononuclear Cells Therapy and 0.9% Sodium Chloride in people with Safety Issues and Effect of Drugs, run by Guangdong Women and Children Hospital 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: status not confirmed, as of the sponsor's last update on 10 Apr 2017. 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 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 who died (time frame: up tp 21 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 NCT03053076, which also lists 2 linked publications.
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 10 Apr 2017.