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The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells

Primary Purpose

Safety Issues, Effect of Drugs

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

mesenchymal stem cells therapy

0.9% sodium chloride

About this trial

This is an interventional treatment trial for Safety Issues focused on measuring mesenchymal stem cells, safety, effect, BPD

Eligibility Criteria

28 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

mesenchymal stem cells

Arm Description

0.9% sodium chloride intratracheal instillate on 14 days after birth

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

Outcomes

Primary Outcome Measures

number of patients with BPD after instillation mesenchymal stem cells

incidence of BPD

Secondary Outcome Measures

Full Information

NCT ID

NCT03683953

First Posted

September 24, 2018

Last Updated

September 24, 2018

Sponsor

Guangdong Women and Children Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03683953

Brief Title

The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells

Official Title

The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 29, 2018 (Anticipated)

Primary Completion Date

August 1, 2019 (Anticipated)

Study Completion Date

July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangdong Women and Children Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

This is a Phase 1 clinical trial that constitues two points cohorts with 100 participants per cohort who will receive instillation dose of mesenchymal stem cells-25 million cells/kg,with ventilation after 14 days.And the placebol will be 0.9% sodium choride. The investigator will proceed the groups during the same period. Deographic Data and Baseline charateristics of the studied groups were collected: Gestational age (weeks) Birth weight (g) gender Cesarean section delivery Antenatal steroids Prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes mesenchymal stem cels dose is 25 million cells/kg Assessment the incidence of BPD after instillation of Mesenchymal stem cells the adverse after instillation of Mesenchymal stem cells

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Safety Issues, Effect of Drugs

Keywords

mesenchymal stem cells, safety, effect, BPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0.9% sodium chloride intratracheal instillate on 14 days after birth

Arm Title

mesenchymal stem cells

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

mesenchymal stem cells therapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

0.9% sodium chloride

Intervention Description

0.9% sodium chloride in control group

Primary Outcome Measure Information:

Title

number of patients with BPD after instillation mesenchymal stem cells

Description

incidence of BPD

Time Frame

up to 28 days after birth

10. Eligibility

Sex

All

Minimum Age & Unit of Time

28 Weeks

Maximum Age & Unit of Time

37 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: twenty-eight weeks to thirty-seven weeks prematures who need ventilaton for 14 days after birth, and the oxygen concentration is more than 30% Exclusion Criteria: Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhuxiao Ren, MD

Phone

+8613538984634

Ext

+86

renzhx1990@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Yang, PHD

Phone

39151777

Ext

020

jieyang0830@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie Yang, PHD

Organizational Affiliation

Guangzhou, Guangdong,China，511442

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26051681

Citation

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.

Results Reference

result

Learn more about this trial

The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells

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