Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)

Cell Transplantation Clinical Trial

Official title:

Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02890953
• Other study ID #: 2016-06-005
• Status: Recruiting
• Phase: Phase 2
• Start date: March 28, 2017
• Est. completion date: December 2021

Study information

• Verified date: April 2019
• Source: Samsung Medical Center
• Contact: So Yoon Ahn, MD. Ph.D
• Phone: +821040380460
• Email: soyoon.ahn[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• IVH grade 3-4

• age : within postnatal day 28

• gestational age: 23-<34 weeks

Exclusion Criteria:

• Patient with severe congenital abnormalities

• Patient with antenatal brain hemorrhage

• Patient with asphyxia or Hypoxic ischemic encepalophathy

• Patient with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)

• Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)

• Patient withCRP > 30 mg/dL; Severe sepsis or shock

• Patient with a history of participating in other clinical studies

• Patient who is considered inappropriate to participate in the study by the investigator

Related Conditions & MeSH terms

• Cell Transplantation

Intervention

Drug:
• Pneumostem
direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap
• Normal saline
direct intracerebroventricular injection of normal saline via ventricular tap

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or shunt operation	Death or shunt operation	until 40 weeks of corrected age
Secondary	ventricular dilatation	volume ratio of ventricle to whole brain in the brain MRI	until 40 weeks of corrected age
Secondary	Death	Death	until 40 weeks of corrected age