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

NCT02890953 | Active Not Recruiting Phase 2

• 1 other identifier: 2016-06-005
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Shunt or death

  Shunt operation or death

  40 weeks of corrected age

Secondary Outcomes (9)

• Death

  at 2years

• Developmental delay in gross motor function, 2y

  at 2years

• Developmental delay Bayley -3

  at 2years

• Developmental delay in KDST, 2y

  at 2 years

• Language delay

  at 2 years, at 5 years

Study Arms (2)

Control

PLACEBO COMPARATOR

Control group receives placebo medication (normal saline)

Drug: Normal saline

MSC group

EXPERIMENTAL

MSC group receives mesenchymal stem cells transplantation (Pneumostem)

Drug: Pneumostem

Interventions

Pneumostem DRUG

direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap

Also known as: Umbilical cord blood derived mesenchymal stem cells

MSC group

Normal saline DRUG

direct intracerebroventricular injection of normal saline via ventricular tap

Control

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• IVH grade 3-4
• age : within postnatal day 28
• gestational age: 23-\<34 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• So Yoon Ahn, MD. Ph.D

  Samsung Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: March 28, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)