NCT03645525

Brief Summary

Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2019

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

August 16, 2018

Last Update Submit

December 27, 2023

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary DysplasiaMesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

  • Oxygen requirement 3 days after transplantation

    Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %

    3 days

Secondary Outcomes (12)

  • Oxygen requirement 7 days after transplantation

    7 days

  • Duration of ventilator dependence

    up to 36 weeks PMA

  • Incidence of severe BPD

    up to 36 weeks PMA

  • Survival rate

    up to 36 weeks PMA

  • Temperature

    3 days

  • +7 more secondary outcomes

Study Arms (2)

Mesenchymal stem cell

EXPERIMENTAL

Human Umbilical Cord-derived Mesenchymal stem cell in the saline

Drug: Human Umbilical Cord-derived Mesenchymal stem cell

placebo

PLACEBO COMPARATOR

saline without mesenchymal stem cell

Drug: placebo

Interventions

Human Umbilical Cord-derived Mesenchymal stem cellDRUG

The Human Umbilical Cord-derived Mesenchymal stem cells suspension (2×10\^7/kg per KG of the infant 's weight ) will be instilled once through a catheter into the infant' s endotracheal tube

Mesenchymal stem cell
placeboDRUG

saline

placebo

Eligibility Criteria

Age2 Weeks - 3 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age
  • Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age

You may not qualify if:

  • Patients with severe congenital diseases
  • Patients with IVH more than 3 grade
  • Patients with severe sepsis
  • Patients with active pulmonary hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 201204, China

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Chen Chao, PhD,MD

    Chiledren's Hospital of Fudan University

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 24, 2018

Study Start

December 1, 2019

Primary Completion

October 30, 2022

Study Completion

April 1, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Locations

CN(3)