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Bronchopulmonary DysplasiaPhase 1/2NCT03774537

Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia

A Phase 1/2 study testing Transplantation of hUC-MSCs and No transplantation of hUC-MSCs in people with Bronchopulmonary Dysplasia, run by Children's Hospital of Chongqing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in premature infants at high risk for Bronchopulmonary Dysplasia（BPD） Read more about this study

Who is it for?
Ages 4 to 14 days
Conditions the study is for
Bronchopulmonary Dysplasia
What is being tested?
Transplantation of hUC-MSCs and No transplantation of hUC-MSCs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Mar 2019to 31 Dec 2021
Phase
Phase 1/2
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 4 to 14 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • An infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)
  • Gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) < 28 weeks)
  • Birth weight is between 500g and 1000g, inclusive
  • Being intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening
  • Written consent form signed by a legal representative or a parent.

Who cannot join

  • Although mechanical ventilation or oxygen is required in participants, there are no signs of dyspnea or BPD-related changes in lung imaging, such as central apnea or diaphragm paralysis.
  • The participants who have complex congenital heart disease.
  • The participants who have severe pulmonary hypertension(cardiac ultrasound confirmed) at the time of assessment.
  • The participants who have severe respiratory tract malformation: pierre-robin syndrome, tracheobronchomalacia, vascular ring syndrome, congenital tracheal stenosis, tracheo-esophageal fistula, pulmonary emphysema, pulmonary sequestration, congenital pulmonary dysplasia, congenital pulmonary cyst, congenital spasm, etc.
  • The participants who have severe chromosome anomalies :Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc).
  • The participants who have severe congenital infection(Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc).
Show all 13Show fewer
  • The participants who have severe sepsis or shock.
  • The participants who is going to have surgery 72 hours before/after this study drug administration.
  • The participants who have surfactant administration within 24 hours before this study drug administration.
  • The participants who have severe intracranial hemorrhage ≥ grade 3 or 4.
  • The participants who have active pulmonary hemorrhage or active air leak syndrome at the time of assessment.
  • The participants who have the history of other clinical studies as a participant.
  • The participants who is considered inappropriate by the investigators.

Trial locations and contacts

1 site in 1 country.

Yunqiu xia contact

13637719980

sunny_199001@foxmail.com

Lin Zou contact

18623121280

China1 site, 1 recruiting

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Yunqiu Xia, 13637719980

    Recruiting

Other trials in China

About this study

Official title: Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Premature Infants Ａt High Risk For Bronchopulmonary

This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in premature infants at high risk for Bronchopulmonary Dysplasia（BPD）

Read the detailed description

BPD is a chronic lung disease that occur in premature infants receiving prolonged oxygen pulmonary and ventilator therapy. It remains a main complication of extreme prematurity and currently lacks efficient treatment.The mortality rate of one year after birth is still high and the quality of life is not optimistic.

hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get. Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to various system diseases and the safety was verified.So, the main purpose of this study is to evaluate the safety and efficacy of hUC-MSCs in participants at high risk for BPD

Being tested
Transplantation of hUC-MSCs, No transplantation of hUC-MSCs
Keywords
high risk； Bronchopulmonary Dysplasia；hUC-MSCs
Medical subject headings
Bronchopulmonary Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transplantation of hUC-MSCsDrug

    Also called Intravenous infusion of hUC-MSCs

    Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs through intravenous infusion. Dose A - 1 million cells per kg; Dose B - 5 million cells per kg

  • No transplantation of hUC-MSCsDrug

    Also called No intravenous infusion of hUC-MSCs

    Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs

Study groups in NCT03774537
Study groupRoleWhat they receive
Transplantation of hUC-MSCsExperimentalPreterm infants at high risk for BPD will receive transplantation of hUC-MSCs.
Receives: Drug: Transplantation of hUC-MSCs
No transplantation of hUC-MSCsOtherPreterm infants at high risk for BPD will not receive transplantation of hUC-MSCs
Receives: Drug: No transplantation of hUC-MSCs

What is being measured

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

  1. Number of participants with adverse reactions related to infusion after treatment

    To evaluate the safety of hUC-MSCs for BPD.

    Measured: 24 hours after administration

Secondary outcomes (6)

  1. The incidence and severity of BPD defined by the National Institutes of Child Health and Human Development (NICHD) workshop.

    To evaluate the efficacy of hUC-MSCs to prevent preterm infants at high risk of BPD from developing BPD

    Measured: at the corrected gestational age of 36 weeks

  2. Changes of high-resolution chest CT in participants

    To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPDmesenchymal stem cells for BPD.

    Measured: within 2 years after administration

  3. Changes of temperature in participants

    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.mesenchymal stem cells for BPD.

    Measured: 3 days after administration

  4. Changes of blood pressure in participants

    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. Blood pressure is measured by electronic sphygmomanometer.

    Measured: 3 days after administration

  5. Changes of respiratory rate in participants

    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.

    Measured: 3 days after administration

  6. Changes of oxygen saturation in participants

    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.

    Measured: 3 days after administration

Timeline

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

  1. First posted13 Dec 2018
  2. Study start1 Mar 2019
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion31 Dec 2021 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03774537
Sponsor's protocol ID
XiaYQ
Status last verified
Mar 2019
First submitted
12 Dec 2018
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chang YS, Ahn SY, Yoo HS, Sung SI, Choi SJ, Oh WI, Park WS. Mesenchymal stem cells for bronchopulmonary dysplasia: phase 1 dose-escalation clinical trial. J Pediatr. 2014 May;164(5):966-972.e6. doi: 10.1016/j.jpeds.2013.12.011. Epub 2014 Feb 6.

    PubMed 24508444

  • Hayes D Jr, Meadows JT Jr, Murphy BS, Feola DJ, Shook LA, Ballard HO. Pulmonary function outcomes in bronchopulmonary dysplasia through childhood and into adulthood: implications for primary care. Prim Care Respir J. 2011 Jun;20(2):128-33. doi: 10.4104/pcrj.2011.00002.

    PubMed 21336467

  • Ahn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21.

    PubMed 28341525

  • Wilson JG, Liu KD, Zhuo H, Caballero L, McMillan M, Fang X, Cosgrove K, Vojnik R, Calfee CS, Lee JW, Rogers AJ, Levitt J, Wiener-Kronish J, Bajwa EK, Leavitt A, McKenna D, Thompson BT, Matthay MA. Mesenchymal stem (stromal) cells for treatment of ARDS: a phase 1 clinical trial. Lancet Respir Med. 2015 Jan;3(1):24-32. doi: 10.1016/S2213-2600(14)70291-7. Epub 2014 Dec 17.

    PubMed 25529339

  • Laube M, Stolzing A, Thome UH, Fabian C. Therapeutic potential of mesenchymal stem cells for pulmonary complications associated with preterm birth. Int J Biochem Cell Biol. 2016 May;74:18-32. doi: 10.1016/j.biocel.2016.02.023. Epub 2016 Feb 27.

    PubMed 26928452

  • Pierro M, Ionescu L, Montemurro T, Vadivel A, Weissmann G, Oudit G, Emery D, Bodiga S, Eaton F, Peault B, Mosca F, Lazzari L, Thebaud B. Short-term, long-term and paracrine effect of human umbilical cord-derived stem cells in lung injury prevention and repair in experimental bronchopulmonary dysplasia. Thorax. 2013 May;68(5):475-84. doi: 10.1136/thoraxjnl-2012-202323. Epub 2012 Dec 4.

    PubMed 23212278

  • Hansmann G, Fernandez-Gonzalez A, Aslam M, Vitali SH, Martin T, Mitsialis SA, Kourembanas S. Mesenchymal stem cell-mediated reversal of bronchopulmonary dysplasia and associated pulmonary hypertension. Pulm Circ. 2012 Apr-Jun;2(2):170-81. doi: 10.4103/2045-8932.97603.

    PubMed 22837858

  • Yeh TF, Chen CM, Wu SY, Husan Z, Li TC, Hsieh WS, Tsai CH, Lin HC. Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia. Am J Respir Crit Care Med. 2016 Jan 1;193(1):86-95. doi: 10.1164/rccm.201505-0861OC.

    PubMed 26351971

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Transplantation of hUC-MSCs and No transplantation of hUC-MSCs in people with Bronchopulmonary Dysplasia, run by Children's Hospital of Chongqing Medical University 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 5 inclusion and 13 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 6 Mar 2019. 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 combined 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yunqiu xia (13637719980, sunny_199001@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse reactions related to infusion after treatment (time frame: 24 hours after administration). 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 NCT03774537, which also lists 8 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 6 Mar 2019.

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