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LSII has been developing novel Muse cell treatments since 2015
in order to respond to unmet medical needs.
Pluripotent stem cells have recently attracted a great deal of attention in regenerative medicine, in which practical use is advancing due to their capacity to differentiate into a variety of cell types in the human body. Muse cells (Multilineage-differentiating stress enduring cells) are the latest addition to this group.
Discovered by Professor Mari Dezawa et al. at Tohoku University in 2010, Muse cells are a novel type of pluripotent stem cell within the human body. Muse cells exist in the blood, bone marrow, and connective tissue of various organs. They have the capacity for triploblastic differentiation; Muse cells can differentiate into various cells within the endoderm (e.g. lungs, liver, pancreas), mesoderm (e.g. heart, kidneys, bones, blood vessels) and ectoderm (e.g. nervous tissue and epidermis). As Muse cells are endogenous to the human body, they have low safety concerns and are characterized by their low tumorigenicity. Due to these characteristics, Muse cells are expected to play an integral role in numerous regenerative therapies for a wide range of diseases.
Regenerative medicine is a field of medicine that focuses on regaining lost or impaired function using cells or tissues. It is expected that diseases untreatable by conventional methods will now become treatable.
Regenerative medical products approved in Japan include the following:
These are novel treatments in which cells derived from either the patient themselves (autologous) or from a donor (allogenic) are cultured and prepared, then subsequently administered to the patient.
In regenerative therapies using Muse cells, Muse cells collected from a donor are administered to the patient directly via intravenous drip. This method does not require gene transfer or differentiation prior to administration, and there is also no need for surgery to deliver cells. Administered Muse cells recognize SOS signals generated by an injured organ, accumulate to the damaged site, spontaneously differentiate into the cells of the injured tissue. They subsequently engraft there and repair the tissues/organ, and finally, restoring once-impaired function.
Thus, regenerative medicine using Muse cells
can be considered to be closer to “Reparative Medicine”.
Regenerative medicine using Muse cells has the following advantages:
As such, this treatment has the potential to become commonplace for patients.
LSII aims to realize Reparative Medicine through research and development of Muse cell-based products.
The key for research and development of "regenerative medical products" is the establishment of manufacturing processes and quality control test methods. Especially when making products of living cells, conventional methods of sterilization such as heating are unsuitable. Therefore, it is necessary to precisely manage each step in the production process, from gathering the raw materials and maintaining cell banks to culturing cells and formulating the final product. This will allow for a manufacturing process that can produce Muse cell-based products of a guaranteed quality and quantity. As a final step, the development of test methods to ensure the quality of Muse cell-based products is also needed.