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

Samsung Medical Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Cell Transplantation

Treatments: Drug: Normal saline; Drug: Pneumostem

Study type: Interventional

Funder types: Other

Identifiers

NCT02890953

2016-06-005

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Control group receives placebo medication (normal saline)

Treatment:

Drug: Normal saline

MSC group

Experimental group

Description:

MSC group receives mesenchymal stem cells transplantation (Pneumostem)

Treatment:

Drug: Pneumostem