Product | Cellgram? | Company | Pharmicell Co., Ltd. |
---|---|---|---|
Classification | Cell Therapy product | Active Ingredient | Autologous Bone Marrow-derived Mesenchymal Stem Cell |
Reference Product | Approval Date | 2011 | |
Indication | Improving Heart functions and lowering the MACE(Major Adverse Cardiac Events) through the improvement of LVEF(Left Ventricular Ejection Fraction) in AMI(Acute Myocardial Infarction) patients | ||
Description |
It was approved from Korea FDA (MFDS) in July 2011 and became the world¡¯s first commercialized stem cell therapy product. The product was approved for improving rapidly decreased cardiac function (ejection fraction) from acute myocardial infarction patient by intracoronary artery infusion. Also, various clinical trials are being conducted for such diseases of stroke, spinal cord injury, liver cirrhosis, erectile dysfunction, and critical limb ischemia. The efficacy of Pharmicell¡¯s stem cell therapy products were introduced via local and international mass communication which gives high reliability of the product. Especially, to precede clinical trials in US for liver cirrhosis, the Pre-IND meeting with US FDA was completed at the beginning of 2014. The clinical trials will begin during the first half of 2017.
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