Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)
- Conditions
- Cell Transplantation
- Interventions
- Drug: Normal saline
- Registration Number
- NCT02890953
- Lead Sponsor
- Samsung Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 22
- IVH grade 3-4
- age : within postnatal day 28
- gestational age: 23-<34 weeks
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Normal saline Control group receives placebo medication (normal saline) MSC group Pneumostem MSC group receives mesenchymal stem cells transplantation (Pneumostem)
- Primary Outcome Measures
Name Time Method Shunt or death 40 weeks of corrected age Shunt operation or death
- Secondary Outcome Measures
Name Time Method Death at 2years Death
Developmental delay in gross motor function, 2y at 2years Cerebral palsy, gross motor function classification system score ≥2
Developmental delay Bayley -3 at 2years Bayley-3 scores \<70
Developmental delay in KDST, 2y at 2 years Korean Developmental Screening Test scores, below two standard deviations was classified as delayed
Language delay at 2 years, at 5 years Korean Sequenced Language Scale for Infant score
Developmental delay in KDST, 5y at 5 years Korean Developmental Screening Test scores, below two standard deviations was classified as delayed
Developmental delay in gross motor function at 2years Cerebral palsy, gross motor function classification system score ≥2
Developmental delay in gross motor function, 5y at 5years Cerebral palsy, gross motor function classification system score ≥2
epilepsy at 2 years, at 5 years epilepsy required anti-seizure medication or treatment
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of