Immunomodulation EffectPhase 1NCT05087498
Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU
A Phase 1 study testing autologous cord blood mononuclear cells and normal saline in people with Immunomodulation Effect, run by Guangdong Women and Children Hospital at 1 site in China.
Trial summary
Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with intravenous ACBMNC infusion in very… Read more about this study
- Who is it for?
- Ages 24 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Immunomodulation Effect
- What is being tested?
- autologous cord blood mononuclear cells and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2021to 18 Aug 2022
- 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 24 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- born at study hospitals;
- monozygotic twins (confirmed by ultrasonographic diagnosis before birth and confirm again with obstetricians during and after delivery, as monochorionic diamniotic twins and monochorionic monoamniotic Twins twins were both monozygotic twins, therefore they will be both eligible);
- gestational age (GA) <32 weeks (GA was calculated based on the date of the last menstrual period of the mother and an ultrasonographic screening performed during the first trimester of pregnancy);
- enrolled within the first 24 postnatal hours;
- free of severe perinatal asphyxia (defined as an Apgar score of 0-3 for more than 5 minutes, a cord blood gas pH <7.00, or both);
- free of severe congenital anomalies or genetic syndromes;
Show all 9Show fewer
- free of maternal sepsis24,25;
- Written informed consent is obtained from the parents or guardians of the infants;
- Either of the twins has available umbilical cord blood (UCB) , and the cell number was no more than 10×107 cells per kilogram, but should not be less than 2×107 cells per kilogram.
Who cannot join
- they exhibit severe congenital abnormalities (detected via prenatal ultrasound); (2) expected to die within the first 24 hours; (3) diagnosed with severe twin-to-twin transfusion syndrome confirmed by prenatal ultrasonography24.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU: a Randomized Controlled Trial -The Premature Autologous Cord-blood Immunomodulatory Study (PAIRS)
Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with intravenous ACBMNC infusion in very preterm monozygotic twins
Read the detailed description
This was a randomized, placebo-controlled, double-blinded trial involving eight pairs of VPMTs who were admitted to NICU to receive respiratory support right after birth. The infants were assigned (1:1) to receiving at least 2×107 ACB-MNCs/kg or normal saline, intravenously, within 24-h post-enrollment within each pair. Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with ACB-MNCs infusion, along with paired controls. Feasibility, safety and clinical outcomes improvement of the ACB-MNCs infusion in both short and long term were also assessed.
- Conditions
- Immunomodulation Effect
- Being tested
- autologous cord blood mononuclear cells, normal saline
- Keywords
- autologous cord blood mononuclear cells, monozygotic twins, very premature infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous cord blood mononuclear cellsBiological
preterm neonates less than 32 weeks are assigned to receive intravenous autologous cord blood mononuclear cells infusion (2-10×107cells/kg) within 24 hours after birth
normal salineBiological
preterm neonates less than 32 weeks are assigned to receive normal saline within 24 hours after birth
| Study group | Role | What they receive |
|---|---|---|
| ACBMNC infusion group | Experimental | Those assigned to the ACBMNC group will receive intravenous autologous cord blood mononuclear cells infusion within 24 h after process. Cell dose for all patients was 2-10×107 cells per kilogram. Receives: Biological: autologous cord blood mononuclear cells |
| control group | Placebo comparator | Those in control group will receive an infusion of a placebo solution which is normal saline with the same volume per kg. Receives: Biological: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunomodulation effect
analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction
Measured: during 7 days after intervention
success rate of cord blood collection
cord blood collection, cell available, infused cell number
Measured: during 6 months after intervention
complications
frequency of complications such IVH, NEC, retinopathy of prematurity (ROP), respiratory distress syndrome (RDS), LOS, and persistent pulmonary hypertension of newborn (PPHN) and anemia.
Measured: during 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start28 Nov 2021
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
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 Immunomodulation EffectStudies 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
- Model description
- eight pairs of VPMTs who were admitted to NICU to receive respiratory support right after birth. The infants were assigned (1:1) to receiving at least 2×107 ACB-MNCs/kg or normal saline, intravenously, within 24-h post-enrollment within each pair.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yang jie, Guangdong Women and Children Hospital
- Investigators
- Jie Yang, Study chair, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087498
- Sponsor's protocol ID
- Guangdong M CH
- Status last verified
- Dec 2023
- First submitted
- 25 Aug 2021
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: public
Publications
Ren Z, Nie C, Xu F, Gao W, Yang S, Han J, Wei W, Yang SY, Zhang Q, Yang J. Autologous Cord Blood Mononuclear Cells Modulate Immunity and the Microbiota in Very Preterm Twins: A Randomized Trial. Stem Cell Rev Rep. 2026 Jul;22(5):2511-2527. doi: 10.1007/s12015-026-11140-6. Epub 2026 Apr 28.
PubMed 42047971Zhuxiao R, Ruoyu H, Liling Y, Xuejun R, Chunhui Y, Wanfen R, Zhifeng C, Yiheng D, Qi Z, Wei W, Zhipeng L, Jingjun P, Qigai Y, Jie Y. Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trial. Front Pediatr. 2022 Dec 9;10:884366. doi: 10.3389/fped.2022.884366. eCollection 2022.
PubMed 36568414
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU: a Randomized Controlled Trial -The Premature Autologous Cord-blood Immunomodulatory Study (PAIRS)
- ClinicalTrials.gov ID
- NCT05087498
- Acronym / sponsor ID
- Guangdong M CH
- Conditions
- Immunomodulation Effect
- Keywords
- autologous cord blood mononuclear cells, monozygotic twins, very premature infants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 21 Oct 2021 (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.
Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with intravenous ACBMNC infusion in very preterm monozygotic twins
Detailed description
This was a randomized, placebo-controlled, double-blinded trial involving eight pairs of VPMTs who were admitted to NICU to receive respiratory support right after birth. The infants were assigned (1:1) to receiving at least 2×107 ACB-MNCs/kg or normal saline, intravenously, within 24-h post-enrollment within each pair. Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with ACB-MNCs infusion, along with paired controls. Feasibility, safety and clinical outcomes improvement of the ACB-MNCs infusion in both short and long term were also assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- eight pairs of VPMTs who were admitted to NICU to receive respiratory support right after birth. The infants were assigned (1:1) to receiving at least 2×107 ACB-MNCs/kg or normal saline, intravenously, within 24-h post-enrollment within each pair.
| Arm | Type | Receives |
|---|---|---|
| ACBMNC infusion group | Experimental | Biological: autologous cord blood mononuclear cellsThose assigned to the ACBMNC group will receive intravenous autologous cord blood mononuclear cells infusion within 24 h after process. Cell dose for all patients was 2-10×107 cells per kilogram. |
| control group | Placebo comparator | Biological: normal salineThose in control group will receive an infusion of a placebo solution which is normal saline with the same volume per kg. |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- born at study hospitals;
- monozygotic twins (confirmed by ultrasonographic diagnosis before birth and confirm again with obstetricians during and after delivery, as monochorionic diamniotic twins and monochorionic monoamniotic Twins twins were both monozygotic twins, therefore they will be both eligible);
- gestational age (GA) <32 weeks (GA was calculated based on the date of the last menstrual period of the mother and an ultrasonographic screening performed during the first trimester of pregnancy);
- enrolled within the first 24 postnatal hours;
- free of severe perinatal asphyxia (defined as an Apgar score of 0-3 for more than 5 minutes, a cord blood gas pH <7.00, or both);
Key exclusion criteria (1 listed)
- they exhibit severe congenital abnormalities (detected via prenatal ultrasound); (2) expected to die within the first 24 hours; (3) diagnosed with severe twin-to-twin transfusion syndrome confirmed by prenatal ultrasonography24.
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 cord blood mononuclear cellspreterm neonates less than 32 weeks are assigned to receive intravenous autologous cord blood mononuclear cells infusion (2-10×107cells/kg) within 24 hours after birth | Biological | ACBMNC infusion group |
| normal salinepreterm neonates less than 32 weeks are assigned to receive normal saline within 24 hours after birth | Biological | control group |
Primary outcome
immunomodulation effect
Time frame: during 7 days after intervention
analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction
success rate of cord blood collection
Time frame: during 6 months after intervention
cord blood collection, cell available, infused cell number
complications
Time frame: during 6 months after intervention
frequency of complications such IVH, NEC, retinopathy of prematurity (ROP), respiratory distress syndrome (RDS), LOS, and persistent pulmonary hypertension of newborn (PPHN) and anemia.
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 Jan 2024.
- Derived from this study: PubMed 42047971Ren Z, Nie C, Xu F, Gao W, Yang S, Han J, Wei W, Yang SY, Zhang Q, Yang J. Autologous Cord Blood Mononuclear Cells Modulate Immunity and the Microbiota in Very Preterm Twins: A Randomized Trial. Stem Cell Rev Rep. 2026 Jul;22(5):2511-2527. doi: 10.1007/s12015-026-11140-6. Epub 2026 Apr 28.
- Derived from this study: PubMed 36568414Zhuxiao R, Ruoyu H, Liling Y, Xuejun R, Chunhui Y, Wanfen R, Zhifeng C, Yiheng D, Qi Z, Wei W, Zhipeng L, Jingjun P, Qigai Y, Jie Y. Autologous cord blood mononuclear cell infusion for the prevention of bronchopulmonary dysplasia in very preterm monozygotic twins: A study protocol for a randomized, placebo-controlled, double-blinded multicenter trial. Front Pediatr. 2022 Dec 9;10:884366. doi: 10.3389/fped.2022.884366. eCollection 2022.
- Individual participant dataSharing planned: Yes. public
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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 study chair
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 cord blood mononuclear cells and normal saline in people with Immunomodulation Effect, 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 9 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: finished, as of the sponsor's last update on 2 Jan 2024. 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?
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?
immunomodulation effect (time frame: during 7 days after intervention). 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?
On the ClinicalTrials.gov record for NCT05087498, 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 2 Jan 2024.