MEDIPOST submitted phase 1 and 2 clinical trial application for premature child bronchial pulmonary dysplasia preventive treatment drug ‘PNEUMOSTEM®’ to US FDA through a US company on 12 August 8.
If this clinical trial application is approved, MEDIPOST will verify the safety and efficacy of ‘PNEUMOSTEM®’ at the same time on premature baby patients in US for around 2 years.
‘PNEUMOSTEM®’ is made from same type cord blood (blood from unbellical cord) originated mesenchyma stem cell, and MEDIPOST anticipates that it will have the effect of regenerating the lung tissues of premature babies and improving inflammation view.
MEDIPOST has the experience and know-how of US clinical trial of cartilage regeneration treatment drug ‘CARTISTEM®’ for which domestic item approval has been obtained, therefore has confidence to obtain approval for US application for ‘PNEUMOSTEM®’ without issues.
MEDIPOST is anticipating that if clinical trial approval is obtained for ‘PNEUMOSTEM®’ in the US which is the strictest in the world, that it will have positive effect on clinical trial and approval in European and Asian countries.