NCT03683953

Brief Summary

To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2018

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

First Submitted

Initial submission to the registry

September 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

September 29, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 25, 2018

Status Verified

July 1, 2018

Enrollment Period

10 months

First QC Date

September 24, 2018

Last Update Submit

September 24, 2018

Conditions

Safety IssuesEffect of Drugs

Keywords

mesenchymal stem cellssafetyeffectBPD

Outcome Measures

Primary Outcomes (1)

  • number of patients with BPD after instillation mesenchymal stem cells

    incidence of BPD

    up to 28 days after birth

Study Arms (2)

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride intratracheal instillate on 14 days after birth

Drug: 0.9% sodium chloride

mesenchymal stem cells

EXPERIMENTAL

mesenchymal stem cells intratracheal instillate on 14 days after birth ,dose is 25 million cells/kg

Other: mesenchymal stem cells therapy

Interventions

mesenchymal stem cells therapyOTHER

mesenchymal stem cells treatement of BPD for safety and effect evaluation0.9% sodium chloride incontrol group

mesenchymal stem cells
0.9% sodium chlorideDRUG

0.9% sodium chloride in control group

Placebo

Eligibility Criteria

Age28 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • twenty-eight weeks to thirty-seven weeks prematures who need ventilaton for 14 days after birth, and the oxygen concentration is more than 30%

You may not qualify if:

  • Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26051681RESULT

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jie Yang, PHD

    Guangzhou, Guangdong,China，511442

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuxiao Ren, MD

CONTACT

+8613538984634renzhx1990@163.com

Jie Yang, PHD

CONTACT

39151777jieyang0830@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 25, 2018

Study Start

September 29, 2018

Primary Completion

August 1, 2019

Study Completion

July 1, 2020

Last Updated

September 25, 2018

Record last verified: 2018-07