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NCT Number: NCT02890953

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cell Transplantation

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pneumostem

Drug

direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap

Other names: Umbilical cord blood derived mesenchymal stem cells

normal saline

Drug

direct intracerebroventricular injection of normal saline via ventricular tap

Primary outcomes

  1. Shunt or death

    Time frame: 40 weeks of corrected age

    Shunt operation or death

Secondary outcomes

  1. Death

    Time frame: at 2years

    Death

  2. Developmental delay in gross motor function, 2y

    Time frame: at 2years

    Cerebral palsy, gross motor function classification system score ≥2

  3. Developmental delay Bayley -3

    Time frame: at 2years

    Bayley-3 scores <70

  4. Developmental delay in KDST, 2y

    Time frame: at 2 years

    Korean Developmental Screening Test scores, below two standard deviations was classified as delayed

  5. Language delay

    Time frame: at 2 years, at 5 years

    Korean Sequenced Language Scale for Infant score

  6. Developmental delay in KDST, 5y

    Time frame: at 5 years

    Korean Developmental Screening Test scores, below two standard deviations was classified as delayed

  7. Developmental delay in gross motor function

    Time frame: at 2years

    Cerebral palsy, gross motor function classification system score ≥2

  8. Developmental delay in gross motor function, 5y

    Time frame: at 5years

    Cerebral palsy, gross motor function classification system score ≥2

  9. epilepsy

    Time frame: at 2 years, at 5 years

    epilepsy required anti-seizure medication or treatment

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Sep 7, 2016
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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