Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Biological Products

(Cell therapy products) Pharmicell Co., Ltd.
  • Registration Date 2016-10-14
  • Hit 3950

Company Information

1. Name

Pharmicell Co., Ltd.

2. Website Address

www.pharmicell.com

3. Location

7th F/L, Ssangbong B/D, Unju-ro 874, Gangnam-gu, Seoul, Korea

4. Contacts

Tel. (82) 2 3496 0114 / Fax. (82) 2 3496 0159

5. References

Pharmaceutical Product Information

1. Brand Name

Cellgram®

2. Active Ingredient

Autologous Bone Marrow-derived Mesenchymal Stem Cell

* Under 60 kg = 10 mL / 5 X 107 cells

61 ~ 80 kg = 14 mL / 7 X 107 cells

Over 81 kg = 18 mL / 9 X 107 cells

3. Indication

Improving Heart functions and lowering the MACE through the improvement of LVEF(Left Ventricular Ejection Fraction) in AMI(Acute Myocardial Infarction) patients

* MACE(Major Adverse Cardiac Events)

- Death

- Cardiac shock or Congestive heart failure

- Re-AMI

- Arrhythmia

4. Information

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 next first half of 2017.

5. Images

Attached File

Division

Written by 한지혜