Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial

Medipost

Status: Completed

Conditions: Bronchopulmonary Dysplasia

Treatments: Biological: Pneumostem®; Biological: normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01897987

MP-CR-009-FU

Details and patient eligibility

About

This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT01828957) will be followed-up until 60 months of corrected age.

Full description

Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: corrected age of 6, 12,18, 24, 36, 48, and 60 months.

Enrollment: 62 patients

Sex: All

Ages: 7 to 7 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject who completed the safety and efficacy evaluations in Pneumostem Phase II clinical trial
• Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

Exclusion criteria

• Subject whose parent or legal representative does not agree to participate in the study
• subject who is considered inappropriate to participate in the study by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 2 patient groups, including a placebo group

Pneumostem®

Experimental group

Description:

A single intratracheal administration of Pneumostem® (1.0 x 10\^7 cells/kg)

Treatment:

Biological: Pneumostem®

normal saline

Placebo Comparator group

Description:

A single intratracheal administration of normal saline

Treatment:

Biological: normal saline