Regenerative Medicine is the process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal functions. In general, regenerative medicine is conducted by three different kinds of cells including embryonic stem cells (ES cells), induced pluripotent stem cells (iPS cells) and somatic stem cells. Our company’s domain area is somatic stem cells and these cells have functions of cell differentiation. Notably, it is generally considered that somatic stem cells which are isolated from a client’s body and cultivated in vitro are less likely to be rejected after returning to the client’s body.
Therefore, we are committed to dealing with somatic stem cells medicine consultation for clinics.
In the case of opening a new clinic specialized in regenerative medicine, it is mandatory to receive permissions from the Certified Special Committee for Regenerative Medicine as well as from a health center, and then submit a provision plan to the Minister of Health, Labour and Welfare (MHLW). In order to establish a Cell Processing Center (CPC) within a clinic, it is also mandatory that a given clinic be investigated by Pharmaceuticals and Medical Devices Agency (PMDA). In addition, after CPC is in place, a regular report of its quality assurance to PMDA is mandatory. We offer a one-stop consultation solution in helping to open regenerative medicine clinics as follows:
- We introduce appropriate experts such as regenerative medicine specialists.
- We offer renovation consultation including the selection of a location, the expansion of an existing facility and other renovation matters.
- We provide appropriate assistance for obtaining permissions as well as submitting legal documents.
- We provide assistance for establishing medical facilities including CPC.
- We provide necessary employment support and human resources education.
- We provide management support after clinics are opened.