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OpenTrials
Completed

NCT Number: NCT02274428

Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage

Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4)

Completed

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Key information

Conditions

Mesenchymal Stromal Cells

Age range

23 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 23-34w
  • IVH grade 3-4, confirmed with brain ultrasonogram
  • within 7 days after IVH diagnosis

Exclusion criteria

  • severe congenital anomaly
  • intrauterine intracranial bleeding
  • intracranial infection
  • severe congenital infection
  • active and uncontrolled infection, CRP>10mg/dl
  • Platelet count <50,000/ml
  • severe metabolic acidosis (PH<7.1, BE<-20)

Treatment and study plan

pneumostem

Drug

human umbilical cord blood derived mesenchymal stem cells

Primary outcomes

  1. unsuspected death or anaphylactic shock

    Time frame: within 6 h after pneumostem transplantation

Secondary outcomes

  1. Death or hydrocephalus required shunt operation

    Time frame: First discharge home, maximum time frame : 1 year

    outcome measurement time frame would not exceed 1 year after birth

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2014
Registry last updated
Apr 19, 2017

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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