Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial

Medipost

Status and phase: Active, not recruiting; Phase 2

Conditions: BPD; Bronchopulmonary Dysplasia

Treatments: Biological: normal saline; Biological: PNEUMOSTEM®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04003857

MP-CR-012-F/U

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 (NCT03392467) 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: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 60 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject who enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product
• 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

---

60 participants in 2 patient groups, including a placebo group

PNEUMOSTEM®

Experimental group

Description:

A single intratracheal administration of Pneumostem® (10.0 x 10\^6 cells/kg)

Treatment:

Biological: PNEUMOSTEM®

normal saline

Placebo Comparator group

Description:

A single intratracheal administration of normal saline

Treatment:

Biological: normal saline