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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03683953
• Other study ID #: Guangdong W CH
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 29, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2018
• Source: Guangdong Women and Children Hospital
• Contact: Zhuxiao Ren, MD
• Phone: +8613538984634
• Email: renzhx1990[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

1. 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

2. mesenchymal stem cels dose is 25 million cells/kg

3. Assessment the incidence of BPD after instillation of Mesenchymal stem cells

4. the adverse after instillation of Mesenchymal stem cells

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Effect of Drugs
• Safety Issues

Intervention

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

Drug:
• 0.9% sodium chloride
0.9% sodium chloride in control group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children Hospital

References & Publications (1)

Mezey É, 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with BPD after instillation mesenchymal stem cells	incidence of BPD	up to 28 days after birth