There's a promising news release on Organ Technologies website:
http://www.organ-technol.co.jp/news
According to that, they've decided to start a non-clinical trial for "treatment of alopecia by regeneration of follicular capsule organ". From the description, it sounds like a safety trial to ensure that there are no tumors or other nasty side effects. The trial will start in July 2018 and should be finished by the end of the year.
It does mention that they were successful in cultivating epithelial stem cells for both mice and humans.
Here's a Google translated version of the PDF they posted on their website:
On non-clinical trial start for hair follicle organ regeneration medicine
Organ Technologies, Inc. (Representative Director: Yasuhiro Sugimura, Organ Technologies, Inc.),
And National Institute of Physical and Chemical Research (RIKEN (President: Hiroshi Matsumoto, hereinafter RIKEN) are in the field of regenerative medicine
A non-clinical trial, which is a preliminary stage of clinical research for "treatment of alopecia by regeneration of follicular capsule organ"
We decided to start it.
Alopecia and its treatment, challenges
Alopecia is a condition that includes male pattern baldness (Androgenetic Alopecia), congenital hair loss, scarring (heat)
Scarring hair loss, women's telogen hair loss, etc. are known, among which Androgenetic Alopecia is 18 million nationwide
It is said that there are more patients than [1]. Hair affects the appearance impression, the society
It is also positioned as a symbol, alopecia is a big shadow to people's quality of life (QOL)
It is thought to give sound. Therefore, social concerns about alopecia and thinning hair
The market is large and various treatment methods exist. On the other hand, treatment of alopecia
Scientific evidence and effects were identified as problems, and the Japanese Association for Dermatological Association presented "Androgenetic Alopecia and female mold release
Guidelines for treatment of hair disease "is indicated [2].
Hair restorative coatings are generally used for hair loss and thin hair treatments. Treatment of Androgenetic Alopecia
As external preparations or internal medications are used, in any case, the effect will be
Sustained administration is necessary to eliminate. In cases where these therapeutic effects are not sufficient,
Autologous single hair follicle implantation that transplants the patient's own occipital hair follicle to the area of alopecia performed in free medical treatment
It is. Because of reimplantation of autologous hair follicles, the limit of the number of hair follicles to be collected and the total number of hair increase
There is a problem in the degree of patient satisfaction from the number of transplantation to the depilation site because it is not possible. These departments
From the subject, expectations are being gained from the development of science-based evidence of hair follicle organ regeneration medicine.
2. Academic background and social significance
Regenerative medicine is expected as 21st century type medical care. The first generation stem cell transfer
Entry therapy (bone marrow transplant etc.), 2nd generation tissue regeneration medicine (epidermal cell sheet etc)
The treatment is being developed for various diseases. Further third generation re
As raw medical care, basic research on "Organ regeneration medicine" has advanced significantly in the past 10 years,
Great expectations are rising for that realization.
RIKEN Bioengineering Science Research Center Senior Organ Derivation Research Institute (ȁ ormory Ȁ ー: Tsuji Tsuji)
In 2007, we developed a cell manipulation technique to regenerate organ bases which are the source of organs [3]. This
, The transplantation of the original organ of the regeneration tooth [3], hair follicle [4], salivary gland [5], lacrimal gland
It pioneered and demonstrated in the world that functional regeneration of [6] is possible. Hair follicles, adult
Since it is the only repeat organ regeneration as hair replacement (hair cycle) within the organization,
It is thought that there are stem cells that have organ-inducing ability. Hair which was announced in 2012
In the package regeneration [4], we considered that the possibility of application to humans from this background is high and carried out research.
From the hair follicle organ of the adult mouse, it exists in the bulge area
Epithelial stem cells and dermal papilla cells which are mesenchymal stem cells
, Regenerate hair follicle primordia by "organogenic base method"
When transplanted into nude mice, it occurs in regenerated hair follicles,
Regenerate the hair shaft (hair) according to the implantation density of the regenerating hair follicle base group
I proved that I can do it. The regenerated hair follicle is surrounded by surrounding tissue
In addition to connecting with nerve nerve muscles and nerves, persistent hair
Maintaining the cycle, functional organ regeneration was demonstrated. From these facts, treatment of alopecia
It was shown the applicability to.
From this result, hair follicle regeneration medicine has new scientific evidence for alopecia treatment
It was shown that it could be a treatment. Furthermore, the hair follicle is an organ (organ), the third generation
As Japan's original original regenerative medicine industry as the world's first regenerative medicine, Japan's revival battle.
3. Clinical application to humans and overcoming them
Application of mice to humans had two major challenges.
1) Development of in vitro amplification method of bulge-derived epithelial stem cells and hair papilla cells
Epithelial stem cells have not been identified in previous studies, and cultured in vitro
It is known that the ability to regenerate hair follicles disappears. So for seven years
Over the years, I overcome this problem with mouse and human cells.
2) Development of stable mass production technology by organogenesis base method
- 3 -
PRESS RELEASE
According to the conventional technique, one millionth of a cellular suspension
The turbid solution is divided into two types of stem cells in a collagen gel at high density, regenerating hair follicles
I was manufacturing organ bases. For clinical application to humans, a certain standard
Technical development to regenerate the regenerated hair follicle organ primordium stably and massively was a challenge. 2016
In the year, "In vitro amplification technology of stem cells constituting the hair follicle base group and stable base production
Kyocera Corporation has entered the development of technology "(press release), and its development
Succeeded.
As a result of these developments, RIKEN, Science hub
Oriental Headquarters "Drug Discovery / Medical Technology Foundation Program: Follicle Regeneration Medicine by Organogenic Base Method, P.S
Tagged (nonclinical research) "has shifted to. In this program, RIKEN is developing human cells
Development and academic validation of amplification / cultivation technology using, Organ Technologies, Inc. is a nonclinical
We are establishing manufacturing / quality control method for testing and developing system. Kyocera shares
In this nonclinical study, the company provides a method for manufacturing new regenerated hair follicle organs and advances support
4. Nonclinical trial for human clinical study
Human regenerative hair follicle organ transplantation
Human follicle regeneration clinical research by
In order to apply it, "
Law concerning securing safety etc. (again
In accordance with the Law Concerning the Securement of Living Medical Safety etc.)
To a person's life and health
According to procedures classified by degree
It is necessary to proceed.
Hair follicle regenerative medicine is used for the patient's own hair follicle
For somatic stem cells removed from
Therefore, "Type 2 regenerative medicine etc."
Applicable to the specified regeneration regenerative medicine committee, the provision plan, after receiving approval, welfare work
I will submit it to the Minister of Labor for implementation. Application for this Specified Accredited Regenerative Medical Committee
Prior to the request, it is necessary to conduct nonclinical studies to test the safety using animals.
To ensure safety in humans
, "Stability of manufacturing method and quality",
In other words, it is used for nonclinical studies in animals
Regenerated hair follicle organ base and human clinical
Regenerated follicular organ primordium used for floor studies
Manufactured by the same manufacturing method, process control
It is equal in quality, has no tumorigenicity
I will be asked. Concretely
Quality control at the time of acceptance of human organizations
Optimization of human stem cell amplification method (addition
Type of factors and number of days of cultivation, etc.), amplifies
Development of quality control method for cells, clinical response of manufacturing raw materials
Change to raw material · material), maintenance of work procedure manual, development of new regenerated follicular organ base production method
It is necessary to establish stabilization of production method, packing / transportation method, use method of sterile manufacturing equipment.
We have been promoting R & D on these.
5. Nonclinical study aimed at clinical research of hair follicle regenerative medicine
In hair follicle regeneration medicine, Androgenetic Alopecia disease
Started with treatment targeting people
It is supposed to do.
After that, female pattern alopecia and scarring
Patients with sexual alopecia or congenital alopecia
Advance development for people
I am on schedule. Androgenetic Alopecia patients
From its normal back occipital scalp
From the collected hair follicles, standard work
According to the method prescribed in the protocol (SOP), epithelial stem cells and hair papilla cells, pigmented stem
Acquire each cell and cultivate. After culturing in vitro and amplification, each cell was cultured
We will manufacture regenerated hair follicle organ base using newly regenerated follicle organ base manufacturing method. this
Nylon suture for pore production is inserted in the regenerated hair follicle organ base, and hair growth is allowed
I am doing it.
As quality control, as a quality control test within the process in the course of culturing, there is a problem during the culturing process
Expression of proteins by flow cytometry and gene expression by PCR
I will inspect the present etc. In the shipping specification test, the final product can be manufactured according to the standard
Whether or not there is morphological observation, cell viability, sterility test, mycoplasma negative test etc.
Contamination inspection will be carried out.
Safety tests carried out on manufactured samples for nonclinical studies showed general toxicity and tumorigenesis
As a sexual test, a plurality of human regenerated hair follicle organ base groups were implanted subcutaneously in the back of the mouse, and the whole body condition
And the state of the transplantation site for a certain period of time.
At the end of the study, histopathological examination and immunohistological examination of whole body tissues, and human regeneration
We will examine the absence of toxicity or malignant tumor formation derived from hair follicle organ base.
In addition, regarding these manufacturing methods, quality control methods, and non-clinical safety tests,
Talking with the Pharmaceuticals and Medical Devices Agency (PMDA) for the implementation of future clinical trials.
6. Future prospects
As a plan, we started production for nonclinical trials from July 2018,
We will conduct a floor safety test. We plan to complete the safety test in 2018. Nonclinical
Based on the results of safety tests, the Committee for Specified Accreditation and Regeneration Medicine and the Certified Clinical Research Committee
After approval of the committee, after submitting deliberations at the committee, submit a plan for provision to the Minister of Health, Labor and Welfare
I will shift to the implementation of clinical research. For the start of clinical research and its details
In addition, it will be announced again before clinical research is carried out.
