Regience

[lacazette]

"It was believed that bio-venture companies, especially who aim drug development, was typically high risk and high return for the investment.
However, now the situation will be changed in Japan, especially in the field of regeneration medicine. “Bills on Safety Assurance of Regenerative Medicine” and “Law for Partial Revision of the Pharmaceutical Affairs Law” will become effective at 25th November this year and they are to become strong driving forces to boost up the field of regenerative medicine. In this circumstance, the risk of the development of regeneration medical products will become drastically mitigated by obtaining seeds, whose clinical data are already filed in clinical researches performed in i.e., universities. Moreover, the regeneration medical products could be launched much earlier by utilizing the temporal approval system, compared with other conventional drugs. In this system, MHLW (Ministry of Health, Labour and Welfare) is able to temporally approve the regeneration medicine products whose clinical data represent safety and suggestive efficacy. After launching the products, further clinical trials will be continued to accumulate the efficacy and safety data for the authorization of the definitive approval. Furthermore, manufacturing of the regeneration medical products derived from human cells are definitively categorized in this new law and allowed to be outsourced as medical service. All together, bio-venture companies could minimize the risk of the development of the regeneration medical product and maximize the return by implementing several pipelines in low costs. Regience seeks to be the leading company in this field of regeneration medicine.

[Renee]

These guys have partnered with leading scientist in the field of hair regeneration who have researched androgenetic alopecia for at least 10-15 years. In a sense they are commercializing treatments/cure by these researchers. They are not starting research from scratch. If anything this puts pressure on other researchers to speed things up.

[lacazette]

"Regience K.K. (hereinafter, Regience) has reached an agreement of co-development with ANRITSU CORPORATION (hereinafter, ANRITSU) to begin the total management system development for regenerative medicine. In this agreement, we will develop a totally integrated management system for regenerative medicine with cell-based regenerative medical products and Personal Data Store (PDS) of the patient."


"Advance into Clinical stage
Novel manufacturing facility for clinical application is settled in Kobe Port Island
Regience K.K. (hereafter, Regience) settles the manufacturing facility in Kobe Port Island
(Kobe Biomedical Innovation Cluster), which enable us to manufacture the regenerative medical products in accordance with GMP régulations"

We are Lucky that japan take the turn a few years ago to become the leading regenerative medecine country. here the 5-10 years timeline for the available REAL CURE sounds to finally become a reality. Without them we would talk more about 15-30 lol ( except China who is the other leader with many clinical trials)

the temporally approval is a benediction, if Regience finalize a protocol during the next 2 years, we could in 2019/2020 see again in the mirror our lovely definitive framing faces haha that day will be unreal

We will have hair ! let's just hope we won't have to go then on the cancer forum section..lol

[nameless]

"Regience K.K. (hereinafter, Regience) has reached an agreement of co-development with ANRITSU CORPORATION (hereinafter, ANRITSU) to begin the total management system development for regenerative medicine. In this agreement, we will develop a totally integrated management system for regenerative medicine with cell-based regenerative medical products and Personal Data Store (PDS) of the patient."


"Advance into Clinical stage
Novel manufacturing facility for clinical application is settled in Kobe Port Island
Regience K.K. (hereafter, Regience) settles the manufacturing facility in Kobe Port Island
(Kobe Biomedical Innovation Cluster), which enable us to manufacture the regenerative medical products in accordance with GMP régulations"

We are Lucky that japan take the turn a few years ago to become the leading regenerative medecine country. here the 5-10 years timeline for the available REAL CURE sounds to finally become a reality. Without them we would talk more about 15-30 lol ( except China who is the other leader with many clinical trials)

the temporally approval is a benediction, if Regience finalize a protocol during the next 2 years, we could in 2019/2020 see again in the mirror our lovely definitive framing faces haha that day will be unreal

We will have hair ! let's just hope we won't have to go then on the cancer forum section..lol

The company that we want pressure put on is Samumed. And Shisheido is putting pressure on Samumed because Shisheido announced an iPS cell hair-loss treatment by 2018. This puts pressure on Samumed to market their SM04554 as fast as possible. I predict that SM04554 will enter the marketplace sometime between fall 2016 and late spring 2017.

[hellouser]

Fantastic news for my mouse!

LOL!!! So true. Anyone else sick of hearing about new mouse research?

[lacazette]

that co development with ANRITSU is damn good, commercialisation tools is becoming reality

29 june 2015
Regience K.K. (hereinafter, Regience) has reached an agreement of co-development with ANRITSU CORPORATION (hereinafter, ANRITSU) to begin the total management system development for regenerative medicine. In this agreement, we will develop a totally integrated management system for regenerative medicine with cell-based regenerative medical products and Personal Data Store (PDS) of the patient.
This co-development aims to contribute greatly to regenerative medicine on-site by providing the solution with the new total management system with collaborating the data system of ANRITSU and regenerative medicine R&D technology, knowledge, and know-how of Regience.
Ministry of Health, Labor and Welfare requires entities which provide regenerative medicine products and/or service to establish its quality management system and each cell processing process management system for clinical care. The authority also requires them long-term monitoring and recording of its effectiveness and safety after its launch based on qualified and temporary regenerative medicine approval system (see the below reference document 1). Establishment of monitoring system that relates vast amounts of data between each regenerative medical product and prognosis of the patient is very important and necessary conditions for regenerative medicine industry growth.
On the other hand, medical institutions and related clinical product and/or service providers take tight safety measures for medical records, medication records, and clinical records of each patient and they are centralized control.

This total integrated monitoring system for regenerative medicine will provide patients and also many medical institutes and related product and/or service providers the below benefits.
 Regenerative medicine products and/or service providers could get feedback of each product linked with the patient prognosis information as all data of each patient like selection of organ or accumulated cells, transportation, cell culturing, and transplantation will be recorded. Medical institutes could make a predictive diagnosis utilizing linked and accumulated personal data of each patient.
 If a trouble happen, they could check immediately past all monitoring data and specify the process and cause.

Masanori Murayama, CEO of Regience, comments as the below;
“We have very rich pipeline of cell origin product candidates that can contribute greatly to regenerative medicine growth and will develop these products and energetically conduct clinical trials. Under this situation, to establish strict product production management system, strict product quality assurance system, relationship with intended patients for clinical care, long-term each patient prognosis monitoring after his/her operation and vast amounts of data come from his/her operation have been the most important issues. With this agreement we expect to get a very significant item for regenerative medicine after we successfully develop the system to solve the above important issues. As a result we expect much more regenerative medicine expansion in Japan. ”

Eiji Matumura, General Manager of Business Originating Center, ANRITSU, comments as the below;
“We have accumulated technical knowledge and know-how in continuously evolving information technology industry for 120 years and more. In our current core test and measurement business, we assure the quality of a broad range information system for mobile broad band service and IoT and also of service and application by providing cutting-edge measuring system and monitoring system of vast amounts of data. We will develop new business area and contribute to develop more safety, secure, and comfortable society with applying our own accumulated know-how and strong points in regenerative medicine.”

[Renee]

Another Japanese researcher dedicated to finding a solution to hair loss: follow the link.

http://www.med.keio.ac.jp/rdb/gcoe-stemcell_en/view.php?i=40

[Renee]

Characterization of human hair follicles
We identified the cell surface markers of stem cell-enriched human bulge cells and, using this marker, successfully isolated and cultured living human bulge cells. We also established the culture conditions for the sustained expression of genes related to trichogenic activity in human dermal papilla cells (patent filed). In vivo assays and 3D cultures for hair follicle reconstitution have been developed. These cultivated cell components and assays will facilitate experiments for the regeneration of hair follicles.

[Renee]

A lot of things coming out of japan. I won't be surprised if they have already solved pattern baldness.

[lacazette]

Yes renee this program from keio university with this researcher sounds good

"The goal of the present project is to bioengineer human hair follicles with the maintenance of their full function and structure, for potential use in the treatment of permanent hair loss. We shall attempt to regenerate human hair follicles using a cell mixture of hair follicle bulge stem cells and dermal papilla cells with optimized hair-inductive capacity. The hair reorganization potency of the cell mixture will be assessed by hair reconstitution assays in vivo or using a 3-D culture system."

Fig 2. Regeneration of human hair follicle using cultured human dermal papilla cells in mice.

I Wonder if he and his university collaborate with a private company to find a protocol based on those in vivo results, like tokyo and osaka univ/researchers are currently doing with Regience. It would mean great competition, and it's what we need

[lacazette]

Another researcher from keio university who work on the project:

Manabu Oyama: Hair follicle stem cell biology and the establishment of regenerative medicine approaches for intractable hair loss disorders