NCT03873506

Brief Summary

This is a follow-up study to investigate the long-term safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs), for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the PhaseⅠtrial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

February 20, 2019

Last Update Submit

March 12, 2019

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary Dysplasiahuman umbilical cord -derived mesenchymal stem cells

Outcome Measures

Primary Outcomes (2)

  • Readmission rate

    within two years

  • Duration of the hospital stay due to respiratory infection

    within two years

Secondary Outcomes (5)

  • Rate of Survival

    within two years

  • Incidence of Tumorigenicity

    within two years

  • Growth measured by Z-score

    within two years

  • Number of neurological developmental delay

    within two years

  • Number of blindness and deafness

    within two years

Study Arms (1)

Mesenchymal Stem Cell

EXPERIMENTAL

A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg)

Drug: transplantation of hUC-MSCs

Interventions

transplantation of hUC-MSCsDRUG

Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.

Also known as: intravenous infusion of hUC-MSCs
Mesenchymal Stem Cell

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subject who completed the safety and efficacy evaluations in hUC-MSCs PhaseⅠ clinical trial
  • Subject with a written consent form signed by a legal representative or a parent

You may not qualify if:

  • Subject whose parent or legal representative does not agree to participate in the study
  • subject who is considered inappropriate to participate the study by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 24508444BACKGROUND

  • 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.

    PMID: 28341525BACKGROUND

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

  • Zhou Fu

    Children's Hospital of Chongqing Medical University

    STUDY CHAIR

Central Study Contacts

Yunqiu Xia

CONTACT

13637719980sunny_199001@foxmail.com

Lin Zou

CONTACT

18623121280

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 20, 2019

First Posted

March 13, 2019

Study Start

July 1, 2018

Primary Completion

July 1, 2020

Study Completion

December 31, 2020

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)