– Bronchopulmonary dysplasia, no clear treatment to date
– To ensure the safety and exploratory effectiveness, plans to discuss the next steps on clinical trials with the US FDA
MEDIPOST announced on the 8th that the US phase 1/2 clinical trial of PNEUMOSTEM® for bronchial pulmonary dysplasia has been completed.
PNEUMOSTEM® consists mainly of mesenchymal stem cells derived from the allogeneic umbilical cord blood (blood in the umbilical cord) and is intended for the prevention and treatment of bronchopulmonary dysplasia (BPD).
Bronchopulmonary dysplasia is a chronic lung disease that occurs in premature infants who have undergone artificial ventilation and oxygen therapy. There is no clear treatment so far and when PNEUMOSTEM® is approved, it is expected to attract the attention of the medical community worldwide.
MEDIPOST conducted clinical trials in 12 patients in June 2016 after obtaining the US Phase 1/2 clinical approval in September 2014. Patients were classified into low and high doses, administered once through intratracheal intubation, with follow-ups occurring after 20 months to verify the safety of each strength.
MEDIPOST has been conducting the Phase II clinical trials of PNEUMOSTEM® since December 2017 in Korea, and aims to obtain a conditional approval by applying for an orphan drug classification as soon as it is finished.
A MEDIPOST representative said, “we plan to announce the results of this clinical trial in international papers and academic seminars,’ adding that “they will enter into discussions with the US FDA regarding the next phase of clinical trials to ensure the statistical effectiveness.”
On the other hand, PNEUMOSTEM® was selected as a research project for the ‘Stem Cell Regenerative Medical Practical Consortium’ by the Ministry of Health and Welfare in 2012.