December 24, 2017

MonuCell

MonuCell®

MonuCell® as a cell product is produced under sterile conditions and contained autologous bone marrow mononuclear stem cells (BM MNCs). To produce MonuCell®, a BM fluid is aspirated from back of a hipbone (iliac crest) of a patient, and BM MNCs is then isolated using density gradient centrifugation.

 

Active substance

BM MNCs as the active substances of MonuCell® express hematological indices and also have the abilities of proliferate and differentiate into different cell lines in order to create new blood vessels.  Among them, hematopoietic stem cells with surface markers CD34 and CD133 are well recognized due to their abilities to create new blood vessels and strengthen heart muscle.

 

Excipient

This product contains normal saline (sodium chloride 0.9%) as the base solution.

 

Dosage form

MonuCell ® as a cell suspension is presented as the following two forms: (i) 10/600-containing 6 x 108 autologous BM MNCs in 10 ml sterile normal saline (sodium chloride 0.9%) for intracoronary artery injection, and (ii) 3/600-containing 6 x 108 autologous BM MNCs in 3 ml sterile normal saline (sodium chloride 0.9%) for intracoronary artery injection.

 

Packaging

Sterile vial

 

Route of administration

  1. Intracoronary artery injection during angiography
  2. Intramuscular injection of heart during open-heart surgery

 

Clinical indication

Treatment of ischemic cardiomyopathy and dilated/congestive cardiomyopathy (DCM) of adults

 

Dosage

  1. for intracoronary artery injection: 6 x 108 to 1×109 autologous BM MNCs in 10 ml sterile normal saline
  2. for intramuscular injection of heart: 6 x 108 to 1×109 autologous BM MNCs in 3 ml sterile normal saline

 

Storage condition

MonuCell ® should be stored at 2 to 8 °C, away from direct sunlight.  It should also be used in 12 hours after production to prevent loss of product efficacy.

 

Contraindications

Use of cytotoxic or immunosuppressant drugs, pericarditis history, and allergy to animal proteins

 

Pregnant women

Use of this product has not been evaluated in pregnant women; therefore, not recommended.

 

Children
Use of this product in patients under 18 years old is not allowed.

 

Warning
It is not recommended if the package is damaged or if the expiration date has passed.

 

Side effects
No side effects have yet been reported.