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

Samsung Medical Center

Status and phase: Completed; Phase 1

Conditions: Mesenchymal Stromal Cells

Treatments: Drug: pneumostem

Study type: Interventional

Funder types: Other

Identifiers

NCT02274428

2014-06-103

Details and patient eligibility

About

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)

Enrollment: 9 patients

Sex: All

Ages: 23 to 34 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

pneumostem group

Other group

Description:

single arm, pneumostem treated infants

Treatment:

Drug: pneumostem