Medical device approval of CellEffic BM (mesenchymal stem cell separation device)

April 12, 2013
Kaneka Corporation (Osaka, Japan; President: Kimikazu Sugawara) has received medical device approval in Europe for CellEffic BM (mesenchymal stem cell separation device), a device that safely and efficiently separates mesenchymal stem cells (MSC)*1 used in regenerative medicine and cell therapy from bone marrow. MSC have already been used in many clinical trials in Japan and other countries, and their safety and effectiveness are already being confirmed. Like iPS cells, there are high hopes for their use in regenerative medicine and cell therapy. The method of separating MSC employed by CellEffic BM differs substantially from conventional centrifugation methods. Using a special non-woven fabric as a filter, bone marrow is processed within a closed system without centrifugation, preventing confusion of patient cells and contamination. It also improves the safety of technicians when preparing cells infected with viruses or other pathogens. Moreover, as the separation of cells only takes around one-fifth the time of conventional methods with an consistent separation efficiency regardless of technician skill, Kaneka hopes that it will become the standard device for separating MSC. Sales of CellEffic BM commenced in Europe in April this year by Kaneka’s European subsidiary, Kaneka Pharma Europe.

CellEffic BM was developed jointly with Professor Junya Toguchida of Kyoto University utilizing the proprietary technology and expertise Kaneka cultivated through R&D of blood purification systems sold as medical devices in Japan, Europe and the United States. CellEffic BM was developed by making modifications and improvements to the closed system of a research purpose device that has been sold in Japan since October 2009, and obtained approval as a medical device. Another distinctive characteristic is that it is capable of recovering two and a half to four times more MSC than the conventional method.*2 Kaneka hopes to contribute to safer and more efficient cell preparation by widely supplying CellEffic BM.

*1 An unspecialized cell found in bone marrow and adipose tissue that is a type of somatic stem cell. Possessing the ability to differentiate into various mesenchymal cells, including muscle, bone, soft tissue and fat, these cells are also capable of self-renewal. The advantage is that by using the individual’s own cells, there is no need to worry about immune rejection. As such, these cells are expected to be used in regenerative medicine together with iPS cells and embryonic stem cells (ES cells).

*2 Research results have been published in the scientific journal Tissue Engineering, while the results of research conducted at another facility (in the United States) were published in the February edition of Cytotherapy.

Health-related fields are positioned as an area of focus within the Declaration of Kaneka United adopted in 2009. We will continue to create materials and products like CellEffic BM that contribute to the health of people and medical treatment.

Overview of device to be sold
○ Product form: Closed system device
○ Features:
1. This device uses a non-woven fabric filter developed by Kaneka and takes advantage of the MSC property of sticking to fiber to allow efficient harvesting of MSC with a single process. Operation time is approximately 20 minutes, which is about one-fifth of that required for conventional density-gradient centrifugation.

2. The number of MSC that can be separated from human bone marrow and harvested with this device is two and a half to four times more than the conventional method, making the cell extraction efficiency substantially better. Therefore, it reduces the amount of the patient’s bone marrow required to harvest a given number of cells.

3. Processing in a closed system is possible, reducing the risk of the patient’s cells mixing with other patients’ cells and also improving the safety of technicians processing patient bone marrow that is infected with viruses or other pathogens.