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Bronchopulmonary DysplasiaPhase 2NCT02999373

Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates

A Phase 2 study testing Autologous Umbilical Cord Blood Mononuclear Cells Therapy in people with Bronchopulmonary Dysplasia and Premature, run by Guangdong Women and Children Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD). Read more about this study

Who is it for?
Ages 0 to 32 weeks
What is being tested?
Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Could I receive a placebo?
No, everyone receives an active treatment
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 0 to 32 weeks
  • All sexes
  • No healthy volunteers
  • Child

Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) GA <32 weeks; (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical chorioamnionitis; (6) the mother was negative for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (7) consent was obtained from the parents or guardians; and (8) after processing, UCB cells were available.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jie Yang

    Guangzhou, Guangdong, 511442

Other trials in China

About this study

Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD).

This single-center, non-randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very preterm neonates, a high-risk population.

Being tested
Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Keywords
prevention, Bronchopulmonary Dysplasia, preterm, cord blood mononuclear cells
Medical subject headings
Bronchopulmonary Dysplasia, Premature Birth, 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 prevention of infection

Study groups in NCT02999373
Study groupRoleWhat they receive
Autologous cord blood mononuclear cellsExperimentalAutologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg
Receives: Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
controlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home

    bronchopulmonary dysplasia rate

    Measured: 36 weeks of postmenstrual age or the discharge

Secondary outcomes (3)

  1. number of patients with severe BPD in survivors

    severe BPD in survivors

    Measured: 36 weeks of postmenstrual age or the discharge

  2. number of patients died before discharge from hospital

    mortality before discharge from hospital

    Measured: before discharge from hospital

  3. the duration of mechanical ventilation

    Other outcomes

    Measured: before discharge from hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study start1 Jul 2018
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2020

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02999373
Sponsor's protocol ID
Guangdong M And C
Status last verified
Oct 2021
First submitted
3 Dec 2016
Last updated
2 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 23673863

  • Mezey E, Nemeth K. Mesenchymal stem cells and infectious diseases: Smarter than drugs. Immunol Lett. 2015 Dec;168(2):208-14. doi: 10.1016/j.imlet.2015.05.020. Epub 2015 Jun 4.

    PubMed 26051681

  • Wannemuehler TJ, Manukyan MC, Brewster BD, Rouch J, Poynter JA, Wang Y, Meldrum DR. Advances in mesenchymal stem cell research in sepsis. J Surg Res. 2012 Mar;173(1):113-26. doi: 10.1016/j.jss.2011.09.053. Epub 2011 Oct 24.

    PubMed 22225756

  • Leung, Kam Tong; Lam, Hugh Simon; Chan, Kathy Yuen Yee, Decreased Frequency of Circulating CD34+Hematopoietic Stem/Progenitor Cells in Preterm Infants with Late-Onset Systemic Bacterial Infection,Blood,2014.124.21

  • Lam HS, Cheung HM, Poon TC, Wong RP, Leung KT, Li K, Ng PC. Neutrophil CD64 for daily surveillance of systemic infection and necrotizing enterocolitis in preterm infants. Clin Chem. 2013 Dec;59(12):1753-60. doi: 10.1373/clinchem.2013.209536. Epub 2013 Sep 17.

    PubMed 24046202

  • Ho MS, Mei SH, Stewart DJ. The Immunomodulatory and Therapeutic Effects of Mesenchymal Stromal Cells for Acute Lung Injury and Sepsis. J Cell Physiol. 2015 Nov;230(11):2606-17. doi: 10.1002/jcp.25028.

    PubMed 25913273

  • van den Berg JP, van Zwieteren N, Westerbeek EA, Garssen J, van Elburg RM. Neonatal modulation of serum cytokine profiles by a specific mixture of anti-inflammatory neutral and acidic oligosaccharides in preterm infants. Cytokine. 2013 Oct;64(1):188-95. doi: 10.1016/j.cyto.2013.07.002. Epub 2013 Aug 2.

    PubMed 23911205

  • Lam HS, Wong SP, Liu FY, Wong HL, Fok TF, Ng PC. Attitudes toward neonatal intensive care treatment of preterm infants with a high risk of developing long-term disabilities. Pediatrics. 2009 Jun;123(6):1501-8. doi: 10.1542/peds.2008-2061.

    PubMed 19482760

  • Strunk T, Inder T, Wang X, Burgner D, Mallard C, Levy O. Infection-induced inflammation and cerebral injury in preterm infants. Lancet Infect Dis. 2014 Aug;14(8):751-762. doi: 10.1016/S1473-3099(14)70710-8. Epub 2014 May 28.

    PubMed 24877996

  • Ren Z, Han J, Zhang Q, Wei W, Li Y, Yang S, Xu F, Nie C. Five-year follow-up of phase II trial of autologous cord blood mononuclear cells for bronchopulmonary dysplasia prevention in very preterm infants. Stem Cells Transl Med. 2026 Jul 20;15(8):szag045. doi: 10.1093/stcltm/szag045.

    PubMed 42522264

  • Ren Z, Yang L, Wang J, Han J, Lin S, Yao Y, Du C, Yang J. Cord blood stem cell-derived Angptl7 ameliorates the severity of bronchopulmonary dysplasia via anti-inflammatory and proangiogenic effects. Mol Med Rep. 2024 Jan;29(1):8. doi: 10.3892/mmr.2023.13131. Epub 2023 Nov 24.

    PubMed 37997800

  • Zhuxiao R, Fang X, Wei W, Shumei Y, Jianlan W, Qiuping L, Jingjun P, Chuan N, Yongsheng L, Zhichun F, Jie Y. Prevention for moderate or severe BPD with intravenous infusion of autologous cord blood mononuclear cells in very preterm infants-a prospective non-randomized placebo-controlled trial and two-year follow up outcomes. EClinicalMedicine. 2023 Feb 16;57:101844. doi: 10.1016/j.eclinm.2023.101844. eCollection 2023 Mar.

    PubMed 36864985

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous Umbilical Cord Blood Mononuclear Cells Therapy in people with Bronchopulmonary Dysplasia and Premature, 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?

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 Nov 2021. 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. 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?

bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home (time frame: 36 weeks of postmenstrual age or the discharge). 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 NCT02999373, which also lists 12 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 Nov 2021.

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