Safety IssuesEarly Phase 1NCT03760900
Safety of Autologous Cord Blood Cells for Preterm Infants.
A Early Phase 1 study testing Autologous Umbilical Cord Blood Stem Cells Therapy in people with Safety Issues and Effect of Drugs, run by Guangdong Women and Children Hospital.
Trial summary
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Safety Issues, Effect of Drugs, Neonatal Death
- What is being tested?
- Autologous Umbilical Cord Blood Stem Cells Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 5 Jun 2016
- Phase
- Early 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 Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Inborn Infants admitted to the Neonatal Intensive Care Unit (NICU) of Guang Dong Women and Children's Hospital were eligible if they were: 1. Preterm: <37 weeks gestation 2. Without congenital abnormalities; 3. Without maternal chorioamnionitis 4. had available UCB. 5.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.
About this study
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
Read the detailed description
Preterm birth complications are one of the leading causes of death among children under 5 years of age. Despite advances in medical care, many survivors face a lifetime of disability, including mental and physical retardation, and chronic lung disease. More recently, both allogenic and autogenic cord blood cells have been applied in the treatment of neonatal conditions such as hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia (BPD).
Objective-To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
Method- This study was a phase I, open-label, single-arm, single center trial to evaluate the safety of autologous, volume- and RBC-reduced non-cyropreserved UCB cell (5×107cells/kg) infusion for preterm infants <37 weeks gestational age. UCB cell characteristics, pre- and post- infusion vital signs, laboratory investigations were recorded. Clinical data including mortality rates and preterm complications were recorded.
Results-After processing, (22.67±4.05) ml UCB cells in volume, (2.67±2.00)×108 cells in number, with (22.67±4.05)×106 CD34+, and (3.72±3.25)×105colony forming cells (CFU-GM), (99.7±0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. No adverse effects were noticed during treatment. All fifteen patients who received UCB infusion survived. The duration of hospitalization ranged from 4 to 65 (30±23.6) days. Regarding preterm complications, no BPD, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) were observed. There were 1/15 (7%) infant with intraventricular hemorrhage (IVH), and 5/15 (33.3%) infants with ventilation-associated pneumonia, 10/15(66.67%) with anemia respectively.
Conclusions-Collection, preparation and infusion of fresh autologous UCB cells to preterm infants is feasible and safe. Adequately powered randomized controlled studies are needed.
- Conditions
- Safety Issues, Effect of Drugs, Neonatal Death
- Being tested
- Autologous Umbilical Cord Blood Stem Cells Therapy
- Keywords
- Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, neonates, Mechanism
- 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 Stem Cells TherapyCombination product
Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth
| Study group | Role | What they receive |
|---|---|---|
| infusion group | Experimental | Autologous Umbilical Cord Blood Stem Cells Therapy Receives: Combination Product: Autologous Umbilical Cord Blood Stem Cells Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
- vital signs
- blood gas analysis
- blood routine
- liver and kidney function before and after infusion will be compared
Measured: during infusion
Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
- vital signs
- blood gas analysis
- blood routine
- liver and kidney function before and after infusion will be compared
Measured: 6 hours after infusion
Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants
- The growth and development curve will be drawn and compared
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Jan 2009
- Primary completion1 Jan 2010
- Study completion5 Jun 2016
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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
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 and Healthy Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760900
- Sponsor's protocol ID
- Guang dong WCH
- Status last verified
- May 2020
- First submitted
- 23 Nov 2018
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Safety of Autologous Cord Blood Cells for Preterm Infants.
- ClinicalTrials.gov ID
- NCT03760900
- Acronym / sponsor ID
- Guang dong WCH
- Conditions
- Safety Issues, Effect of Drugs, Neonatal Death
- Keywords
- Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, neonates, Mechanism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Jan 2010 (actual)
- Study completion
- 5 Jun 2016 (actual)
- First posted
- 30 Nov 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 assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
Detailed description
Preterm birth complications are one of the leading causes of death among children under 5 years of age. Despite advances in medical care, many survivors face a lifetime of disability, including mental and physical retardation, and chronic lung disease. More recently, both allogenic and autogenic cord blood cells have been applied in the treatment of neonatal conditions such as hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia (BPD).
Objective-To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
Method- This study was a phase I, open-label, single-arm, single center trial to evaluate the safety of autologous, volume- and RBC-reduced non-cyropreserved UCB cell (5×107cells/kg) infusion for preterm infants <37 weeks gestational age. UCB cell characteristics, pre- and post- infusion vital signs, laboratory investigations were recorded. Clinical data including mortality rates and preterm complications were recorded.
Results-After processing, (22.67±4.05) ml UCB cells in volume, (2.67±2.00)×108 cells in number, with (22.67±4.05)×106 CD34+, and (3.72±3.25)×105colony forming cells (CFU-GM), (99.7±0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. No adverse effects were noticed during treatment. All fifteen patients who received UCB infusion survived. The duration of hospitalization ranged from 4 to 65 (30±23.6) days. Regarding preterm complications, no BPD, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) were observed. There were 1/15 (7%) infant with intraventricular hemorrhage (IVH), and 5/15 (33.3%) infants with ventilation-associated pneumonia, 10/15(66.67%) with anemia respectively.
Conclusions-Collection, preparation and infusion of fresh autologous UCB cells to preterm infants is feasible and safe. Adequately powered randomized controlled studies are needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infusion group | Experimental | Combination Product: Autologous Umbilical Cord Blood Stem Cells TherapyAutologous Umbilical Cord Blood Stem Cells Therapy |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 Cells TherapyAutologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth | Combination product | infusion group |
Primary outcome
Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
Time frame: during infusion
1. vital signs 2. blood gas analysis 3. blood routine 4. liver and kidney function before and after infusion will be compared
Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants
Time frame: 6 hours after infusion
1. vital signs 2. blood gas analysis 3. blood routine 4. liver and kidney function before and after infusion will be compared
Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants
Time frame: 2years
1. The growth and development curve will be drawn and compared
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.
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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 and Healthy Institutes
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Autologous Umbilical Cord Blood Stem Cells Therapy 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?
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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants (time frame: during infusion). The study lists 3 primary outcomes in all. 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.