Safety IssuesPhase 1NCT03696745
The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
A Phase 1 study testing autologous umbilical cord blood stem cells 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 safety and effect of autologous umbilical cord blood stem cells for treatment brain injury Read more about this study
- Who is it for?
- Ages 28 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Effect of Drugs
- What is being tested?
- autologous umbilical cord blood stem cells 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
- No sites listed yet
- Study dates
- 1 Nov 2018to 1 Sep 2021
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Mothers must have consented for cord blood collection at delivery
- cord blood must be available for extraction of stem cells.
- ->28 weeks gestation,<37weeks gestation
- cord or neonatal pH<7.0 or base deficit>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
- either a 10 minute Apgar < 5 or continued need for ventilation.
- All infants must have signs of encephalopathy within 6 hours of age.
Who cannot join
- Presence of known chromosomal anomaly.
- Presence of major congenital anomalies.
- Severe intrauterine growth restriction (weight <1800g)
- Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
- Parents refuse consent.
- Attending neonatologist refuses consent.
- Failure to collect the infant's cord blood and/or laboratory unable to process cord blood.
Trial locations and contacts
No sites are listed yet.
About this study
To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury
Read the detailed description
The purpose of this study is to evaluate the safety and effect of infusions of autologous (the patient's own)umbilical cord blood stem cells in newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood stem cells for the Gunagdong Cord Blood Bank,or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood stem cells if an adequate number of cells that meet Guangdong Cord Blood Bank Quality standards are available in the first 14 postnatal days. Study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months. MRI's will be obtained per clinical routine and results will be analyzed and described in study reports.
- Conditions
- Safety Issues, Effect of Drugs
- Being tested
- autologous umbilical cord blood stem cells, 0.9% Sodium-chloride
- Keywords
- Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, brain injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous umbilical cord blood stem cellsOther
autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation
0.9% Sodium-chlorideDrug
0.9% Sodium-chloride in control group
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | preterm infants with severe hypoxic ischemic encephalopathy receive only 0.9% Sodium-chloride Receives: Drug: 0.9% Sodium-chloride |
| infusion | Experimental | preterm infants with severe hypoxic ischemic encephalopathy will receive up to 4 infusions of their own volume reduced cord blood stem cells. The number of doses will be determined by the amount of available cord blood stem cells. The dose for each infusion is 5x107 cells/kg Receives: Other: autologous umbilical cord blood stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants
Adverse event rates occurring will be compared between the autologous umbilical cord blood stem cells recipients and control group
Measured: during infusion 24 hours after infusion
Secondary outcomes (1)
effect of autologous umbilical cord blood stem cells infusion in enrolled preterm infants
the effect of autologous umbilical cord blood stem cells infusion will be measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2021 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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, Gunagzhou,Guangdong,China,511442
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696745
- Sponsor's protocol ID
- GuangdongW C H
- Status last verified
- Oct 2018
- First submitted
- 3 Oct 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- 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 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
- ClinicalTrials.gov ID
- NCT03696745
- Acronym / sponsor ID
- GuangdongW C H
- Conditions
- Safety Issues, Effect of Drugs
- Keywords
- Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, brain injury
- 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
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 5 Oct 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 safety and effect of autologous umbilical cord blood stem cells for treatment brain injury
Detailed description
The purpose of this study is to evaluate the safety and effect of infusions of autologous (the patient's own)umbilical cord blood stem cells in newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood stem cells for the Gunagdong Cord Blood Bank,or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood stem cells if an adequate number of cells that meet Guangdong Cord Blood Bank Quality standards are available in the first 14 postnatal days. Study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months. MRI's will be obtained per clinical routine and results will be analyzed and described in study reports.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0.9% Sodium-chloridepreterm infants with severe hypoxic ischemic encephalopathy receive only 0.9% Sodium-chloride |
| infusion | Experimental | Other: autologous umbilical cord blood stem cellspreterm infants with severe hypoxic ischemic encephalopathy will receive up to 4 infusions of their own volume reduced cord blood stem cells. The number of doses will be determined by the amount of available cord blood stem cells. The dose for each infusion is 5x107 cells/kg |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Mothers must have consented for cord blood collection at delivery
- cord blood must be available for extraction of stem cells.
- ->28 weeks gestation,<37weeks gestation
- cord or neonatal pH<7.0 or base deficit>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
- either a 10 minute Apgar < 5 or continued need for ventilation.
Key exclusion criteria (7 listed)
- Presence of known chromosomal anomaly.
- Presence of major congenital anomalies.
- Severe intrauterine growth restriction (weight <1800g)
- Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
- Parents refuse consent.
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 stem cellsautologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation | Other | infusion |
| 0.9% Sodium-chloride0.9% Sodium-chloride in control group | Drug | Placebo |
Primary outcome
safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants
Time frame: during infusion 24 hours after infusion
Adverse event rates occurring will be compared between the autologous umbilical cord blood stem cells recipients and control group
1 secondary outcome
effect of autologous umbilical cord blood stem cells infusion in enrolled preterm infants
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- 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
Gunagzhou,Guangdong,China,511442
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous umbilical cord blood stem cells 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 6 inclusion and 7 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 5 Oct 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?
safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants (time frame: during infusion 24 hours after infusion). 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 5 Oct 2018.