When I was in the United States, I was working as the director of clinical development at a foreign pharmaceutical company. I was involved in a cell therapy project that was under development by the U.S. head office. Although it was still in its early stages of development, it was a project to utilize mesenchymal stromal cells from usually discarded placentas to treat children with congenital disorders.
At that time, the target was an 11-year-old boy with a congenital genetic disorder, but since his physical health had deteriorated considerably, he was unable to tolerate intensive chemotherapy and undergo bone marrow transplantation, which was said to be the only treatment.
However, when the patient was treated with placenta-derived mesenchymal stromal cells derived, he was able to recover enough to make bone marrow transplantation possible. Subsequently, after meeting the boy in complete remission, I felt that "Cells from the placenta that would have been discarded can lead to new treatment. This has great future potential," and I felt a strong urge to disseminate this cell therapy throughout the rest of my working life.
After returning from the United States, the desire to disseminate cell therapy became more and more intense, so I decided to start a business. At that time, I felt it was necessary to acquire management-related skills, such as finance and accountability that I was lacking in, so I resigned from the company and went to New York. There, I entered an MBA course and developed a business plan while studying.
After obtaining an MBA in one year, and at the same time, my business plan was fairly set, and I returned to Japan. After returning, I was appointed Executive Officer, General Manager of Sales and Marketing Division at a bio startup company. In addition to global business experience, I was able to experience all three elements necessary for Biotech: R&D, marketing, and management.
My first encounter with cell therapy was of placental origin, but I had been involved in a study on hematopoietic stem cells derived from umbilical cord blood since 20 years ago at the Institute of Medical Science, the University of Tokyo (IMSUT), which I call my second alma mater.
By chance, Dr. Tokiko Nagamura of IMSUT, who was a collaborator in that study, had arrived to the stage just prior to clinical studies for umbilical cord-derived mesenchymal stromal cells, so the potential of the umbilical cord was well understood.
In April 2017, Human Life CORD Japan Inc. was established in collaboration with IMSUT, the Institute’s desire to pass on the technical expertise and human resources related to manufacturing, my plan of building infrastructure that was developed in New York and timing for introducing a stable supply of mesenchymal stromal cells were all aligned.
During the first two years, we encountered large barriers. In Japan, discarding of umbilical cords delivered at birth must be in accordance with regulations established by each municipality, and the umbilical cords must be commissioned to specialists designated by the municipality and discarded. It cannot be used except for research purposes, and it cannot be sold as a product. This was the biggest barrier to us.
Still, with the belief that umbilical cords were essential for cell medicine in the future, and that we would definitely become a game changer, in 2019, two years after starting the company, the Tokyo Metropolitan Bureau of Health and Welfare was the first in Japan to relax this rule, and the umbilical cord became available as a raw material for cell products.
This was a big moment when things started to open up for us, since we aimed to commercialize umbilical cord-derived mesenchymal stromal cells. The use of discarded materials is also a major advantage to donors, since it is not invasive, and as well as a stable supply through domestic raw materials.
A major turning point was in 2019. Around this time, when the regulations were relaxed and the supply chain was fairly established, the company entered into the Tokyo Venture Championship 2019, which was based on the concept of sending out unicorn companies from Tokyo. We gratefully received the grand prize (Tokyo Governor Prize). As a result, we were able to gain name recognition and trust, which provided a major impetus for our business development.
Our mission is to realize practical applications for mesenchymal stromal cells derived from the umbilical cord as early as possible. It is by no means a dream that the world's expertise in manufacturing and quality control, born in Japan, can become the world standard, and lead to global realization by effectively utilizing something that has been discarded. We will steadily build solid evidence for the world's first commercialization of umbilical cord-derived mesenchymal stromal cells and transform the society into one that can utilize stockpiled umbilical cords.
Our challenge continues to be to use umbilical cord cells to realize a world where growing older is more enjoyable.