Market Approval by MFDS in January 2012100%
Completion of US FDA phase 1/2a clinical trial60%
Approval of Phase 2 clinical trial by PMDA & MHLW, Japan67%
Treatment of repetitive and/or traumatic cartilage degeneration including Degenerative Osteoarthritis(OA) without age limit.
CARTISTEM® – allogeneic umbilical cord blood-derived mesenchymal stem cells, is used for the treatment of knee cartilage defects in patients with Osteoarthritis (with ICRS grade* IV cartilage defect) caused by degeneration or repetitive trauma.
*ICRS grade : A diagnostic criteria used for grading the severity of cartilage defect. Grade IV is the most severe stage with no visible cartilage remaining on the area of defect.
|· Product :||CARTISTEM®
(human Umbilical Cord Blood-derived
Mesenchymal Stem Cells)
|· Manufacturer :||MEDIPOST Co., Ltd.|
|· Indication :||Treatment of repetitive and/or
traumatic cartilage degeneration
including Degenerative Osteoarthritis
(with ICRS grade IV cartilage defect)
without age limit.
|· Route of Administration|
& Dosage :
|Surgical administration at
2.5 x 106 cells/500㎕/cm2
(size of knee cartilage defects).
Commercialization of CARTISTEM®
CARTISTEM® has been market-approved with Biologics License Application(BLA) for commercial sale by the Ministry of Food & Drug Safety(MFDS) in January 2012.