World’s first off-the-shelf allogeneic cord-blood stem cell drug CARTISTEM® – Journey to the market

Speaking on the above topic is Antonio Lee, Associate Director,Medipost, South Korea. He will be speaking at 5th Annual BioPharma Asia Convention 2012, held on 19th to 22nd March 2012 at Marina Bay Sands, Singapore. He will be conducting an on-floor seminar at Theatre 3 at 13:00 on the 21st of March.

Here is a short abstract of his presentation:

Human umbilical cord blood-derived Mesenchymal Stem Cells (hUCB-MSCs) are a robust source for not only giving rise to a new cell type in need but also for secreting various trophic factors which will signal the activation of host’s own stem cells for producing required cell types and drive the regenerative process.

MEDIPOST has made R&D efforts for over 10 years for developing adult stem cell drugs to meet unmet medical needs in areas such as osteoarthritis, stroke, Alzheimer’s disease, bronchopulmonary dysplasia (BPD) and improving the efficacy of hematopoietic stem cell transplantation (HSCT).

Through rigorous pre-clinical studies and clinical trials, we have proven the safety and efficacy of hUCB-MSCs as adult stem cell drug materials. The drug products under development include CARTISTEM® for cartilage regeneration, which has completed Phase III clinical trial in Korea and in January 2012, obtained a Biologics License Application (BLA) approval from the Korea FDA. With this historical market-approval, CARTISTEM® has become the world’s first allogeneic adult stem cell drug for treating patients with osteoarthritis (OA). CARTISTEM® has also received an Investigational New Drug (IND) clearance from the US-FDA in February 2011 and the Phase I/IIa clinical trial will soon commence in the U.S..

Other hUCB-MSC products named PNEUMOSTEM® for treating Bronchopulmonary
Dysplasia (BPD) and NEUROSTEM-AD® for treating Alzheimer's Disease (AD) have both
completed Phase I clinical trials in Korea.

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