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Gemacell/Cryocell IHD

Gemacell is HSCI’s cell-based drug candidate for treatment of myocardial infarction.

According to project plans, Gemacell production will begin at HSCI’s new laboratory and production complex in several years. The drug is designed to treat myocardial infarction (ischemic heart disease - IHD) and has already passed pre-clinical studies.

The drug is based on nucleated cord blood cells recovered and isolated via a technology which fully eliminates blood plasma, platelets and red blood cells from the drug. The suspension is packaged in a cryogenic tube containing 100 million nuclear cells stored in liquid nitrogen vapors.

The anticipated mechanism of action of the product is based on cytoprotective effect of hematopoietic stem cells and their ability to stimulate the regenerative potential of the damaged organ.

Gemacell was developed based on Cryocell, the first cell-based drug for HSCI.

Cryocell is a concentrate of mononuclear cells isolated from umbilical cord blood and stored in cryobags in liquid nitrogen vapor. The drug was created as part of a treatment program for acute myocardial infarction (7-10 days following a heart attack).The drug is undergoing clinical trials (Phase II).

Thus, the Company is pursuing two clinical trials protocols: Cryocell IHD and Gemacell IHD. 

But, as of now, it is not possible to continue the drug development process. In Russia, starting in 2011, the cell-based products registration procedures were ceased and it has not been legally possible to receive regulator’s permission to conduct clinical trials of cell-based drugs for the purpose of commercialization because the work on the new legislation on cell-based technologies is under way.  Аn approval of the new Federal law on regulation of biomedical cell technologies may take place, at the earliest, only in 2015.