Cell Transplantation
Conditions
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.
Interventions
DRUGPneumostem
direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap
DRUGNormal saline
direct intracerebroventricular injection of normal saline via ventricular tap
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shunt or death | 40 weeks of corrected age | Shunt operation or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Death | at 2years | Death |
| 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 |
| Developmental delay in KDST, 5y | at 5 years | Korean Developmental Screening Test scores, below two standard deviations was classified as delayed |
Countries
South Korea
Outcome results
None listed