Culture technology with the necessary specifications for clinical practice

Pioneer of regenerative medicine in Japan


Before the enforcement of the Act on the Safety of Regenerative Medicine, we started a regenerative medicine support business for patients suffering from intractable diseases or severe disorders by providing technical support to medical institutions that provided regenerative medicine.

Although mesenchymal stem cells were already known to be effective in the treatment of intractable diseases at that time, it remained difficult for such cells to become widespread as medicine because of issues in the development of regulations for approval or issues in the level of technology to provide safe cells.

To provide safe regenerative medicine, the safety of manufacturing-related raw materials, such as media used for cell cultures, is essential and is the responsibility of the providers. We possess a culture system to prepare cells without using any serum, extracts of biological origin, or substances purified from them and have provided culture techniques to medical institutions that provide regenerative medicine for patients.

Features of our medium


Our medium has seven features:

Feature1

Development policy of free from animal- and human-derived components

Animal Origin-Free (AOF) medium, which is free from animal- and human-derived components, facilitates the verification of compliance with the Standard for Biological Ingredients during the development stage and is directly linked to safety during the clinical stage. This product policy is well established in our development strategy.

Development policy of free from animal- and human-derived components

Feature2

Designed MSC "Nao Cell®"

Because of its AOF nature, which is free from serum that has a significant effect on cell characteristics, our medium allows for sharp cell modification not shared by serum media when supplemented with specific components that stimulate MSCs.

Feature3

Excellent growth performance

Cells prepared in our medium exhibit excellent growth characteristics. This feature helps to reduce the manufacturing cost by shortening the time required for cell preparation and to avoid deviations of manufacturing defects.

(Shown below: Study on the growth of adipose-derived MSCs)

Excellent growth performance

Feature4

Primary pharmacodynamic studies in various disease animal models

Previous studies in various disease animal models have demonstrated that our mesenchymal stem cells or culture conditioned medium improve disease symptoms. Some of the outcomes have been reported in the form of conference presentations or published papers.

「Neuropathic pain model」

A single dose of adipose-derived MSCs (AD-MSCs) through the tail vein in the rat sciatic nerve ligation model produced a significant long-term improvement of a decreased pain threshold to mechanical stimuli in the affected hind limb. In addition, the number of macrophages that accumulated in the dorsal root ganglion (DRG) in response to neuropathy was markedly reduced.
Treatment with MSCs is promising in pain associated with neurological disorders or intractable neuropathic pain, such as herpes zoster-associated pain.

「Neuropathic pain model

Results of joint research with the Division of Cancer Pathophysiology, National Cancer Center Research Institute

「Impaired intestinal mucosal immunity model」

In a study in the mouse model of impaired intestinal mucosal immunity due to aging, we reported that a single dose of adipose-derived MSCs (AD-MSCs) from the human or mouse through the tail vein produced recovery from impaired intestinal mucosal immunity due to aging. In mice immunized with ovalbumin (OVA), the titer of secretory IgA antibody to OVA was markedly improved in the feces. These findings indicated the potential for use in the prevention of infections in old age.

Impaired intestinal mucosal immunity model

Results of joint research with the Immunology Vaccine Center, University of Alabama at Birmingham, USA

「Inflammatory bowel disease model」

A single dose of adipose- or umbilical cord-derived MSCs (AD-MSCs or UC-MSCs) via the tail vein improved DAI scores, down-regulated inflammatory factors in the intestinal tissue, and significantly improved intestinal pathological scores in the mouse model of DSS-induced inflammatory bowel disease.

Inflammatory bowel disease model

Results of joint research with the Department of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences of Niigata University

Feature5

Safety studies

Safety studies of cells prepared in our medium are conducted by third party organizations to confirm safety.

「Tumorigenicity studies」

It was confirmed that cells possessed no tumorigenic potential following subcutaneous transplantation in NOG mice.

Tumorigenicity studies

「G-band method」

It was confirmed that cells cultured in our medium had normal chromosomes.

Feature6

Experience in manufacturing of media used in clinical practice

Since 2012, the cumulative quantity of media manufactured by us for mesenchymal stem cells has reached to approximately 2,400 liters (as of July 2019). The quantity has continued to grow after the enforcement of the Act on the Safety of Regenerative Medicine, and experience has been accumulated to prepare cells used for treatment. We will work to ensure a stable supply in close cooperation with raw material manufacturers and to maintain and improve quality so that our medium can contribute to a secure regenerative medicine.

Feature7

Our technology has been adopted by leading pharmaceutical companies for the manufacture of investigational products

Based on such experience and the assessment of safe quality, we have recently succeeded in introducing our technology into pharmaceutical companies that work to develop cell therapy and gene therapy products, which have been used for the development of cell-based medicinal products. In the near future, cell therapy and gene therapy products to treat intractable diseases will be manufactured based on our medium technology.

Contact

For consultations with and inquiries regarding BioMimetics Sympathies Inc, please feel free to contact us from the designated page.