Phase I Clinical Trials of PNEUMOSTEM Treatment in Premature Infants with Intraventricular Hemorrhage

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001325

Enrollment

Registered

2014-12-23

Start date

2014-11-14

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Stem Cell : Drug: Pneumostem(human umbilical cord blood derived mesenchymal stem cells) Pneumostem will be administered as an intraventricular injection at one time. level A :

If 1 or below of the first 3 subjects experience a dose limiting toxicity,3 subjects will receive dose level B -&gt

Evaluation of dose limiting toxicity in 6 subjects -&gt

End of study method2. If the first 3 subjects at dose level A do not experience a dose limiting toxicity,3 subjects will receive dose level B -&gt

If 2 or more of the first 3 subjects experience a dose limiting toxicity, -&gt

3 additional subject will be enrolled at dose level A -&gt

Evaluation of dose limiting toxicity in 6 subjects -&gt

End of study method3. If 1 or below of the first 3 subjects experience a dose limiting toxicity at dose level A -&gt

If 1 or below of the 3subjects experience a dose limiting toxicity -&gt

subjects will receive dose level B -&gt

If 1 or below of the 3subjects experience a dose limiting toxicity -&gt

3 additional subject will be enrolled at dose level B -&gt

End of study method4. If 1 or below of the first 3 subjects experience a dose limiting toxicity at dose level A -&gt

3 additional subject will be enrolled at dose level A -&gt

If 1 or below of the 3subjects ex

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Gestational aged 23-34weeks •IVH grade 3-4, confirmed with brain ultrasonogram •within 7 days after IVH diagnosis •Willing and able to provide written informed consent and to comply with the protocol, visit schedule, and requirements.

Exclusion criteria

Exclusion criteria: •severe congenital anomaly(Hydrocephalus, Encephalocele etc.) •intrauterine intracranial bleeding •intracranial infection •congenital abnormalities of the heart,chromosomal abnormality,severe congenital abnormality •severe congenital infection(Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS etc.) •active and uncontrolled infection, CRP>10mg/dl •Platelet count <50,000/ml •severe metabolic acidosis (PH<7.1, BE<-20) •surgery or death are predicted within 72 hours befor and after administration of the study drug •Subject is enrolled in any other clinical Trial •Likely to be non-compliant or uncooperative during the study, as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
Dose limiting toxicity ;tumor lesion	—

Secondary

Measure	Time frame
Death or hydrocephalus required shunt operation ;Dilated ventricle volume ratio ;Cystic lesion of periventricular area;Decrease Inflammatory cytokine of the cerebrospinal fluid;Head circumference growth rate;Seizure,duration of taking the anticonvulsant.;progression of ventricular dilation	—

Countries

Korea, Republic of

Contacts

Public ContactSo Ahn

Samsung Medical Center

Outcome results