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In January 2012, the Korea Food and Drug Administration (KFDA) has approved
the manufacture and sale of CARTISTEM® in
Korea, as a safe and effective stem cell drug for the treatment of Traumatic
and Degenerative Osteoarthritis (OA).
CARTISTEM® contains
specially selected and grown stem cells from the blood contained within the
umbilical-dords donated by willing mothers who have agreed their umbilical cords
to be used for the development of stem cell drugs to cure incurable disease.
CARTISTEM® contains
a special type of stem cells obtained from the umbilical cord blood (UCB)
known as Mesenchymal Stem Cells (MSCs), which have a very unique characteristic
of not provoking an immune response when administered into another individual.
This makes CARTISTEM® a
safe stem cell drug using the stem cells obtained from another individual (a
term known as 'allogeneic') rather than from the patient him/herself (a term
known as 'autologous').
With the approval from the KFDA, CARTISTEM® has
become the World's First Allogeneic, Off-the-Shelf, Stem Cell Drug and is now
available in Korea through the sales and distribution by Dong-A
Pharmaceuticals Co., Ltd.
CARTISTEM® has
also received US FDA clearance to conduct Phase
I/IIa clinical trials in the US.
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