Japanese clinical trial of cell therapy for pattern baldness launched.
VANCOUVER, B.C., July 21, 2016 - RepliCel Life Sciences Inc. (OTCQB:REPCF) said that its RCH-01 autologous cell therapy for the treatment of androgenetic alopecia was approved by the Japanese regulatory authorities for use in a clinical research study launching now.
The study, designed for 60 men and women with thinning hair caused by androgenetic alopecia, will be conducted at Tokyo Medical University Hospital and Toho University Ohasi Medical Center.
Clinical endpoints will include measures of safety and efficacy based on hair fiber thickness and density.
The study is being financed by Shiseido Company and each product being injected will be manufactured by Shiseido at their SPEC (Cell-Processing and Expansion Center) facility in Kobe, Japan.
RepliCel helped Shiseido design, validate, and prepare the SPEC facility for certification by Japan's PMDA (Pharmaceuticals and Medical Device Agency). Shiseido's SPEC team was also trained by RepliCel and Innovacell in the GMP (Good Manufacturing Practice) compliant production protocols for RCH-01.
Shiseido has an exclusive marketing license to the product for certain Asian countries under a license and co-development agreement with product developer RepliCel signed in 2013.
As part of the agreement, RepliCel trained the clinical investigatory team on critical elements of both the patient biopsy procedure and injection of the cellular product into the patient's scalp.
Furthermore, the injector being used in this study mimics RepliCel's patented, first-generation injection technology.
Shiseido will share the clinical data from this study with RepliCel, thus further strengthening the collective data package being created on RCH-01.
The data may be sufficient for Shiseido to bring RCH-01 to market in Japan.
But it will also be valuable to RepliCel to inform further product development and clinical testing decisions, for use in submissions to other regulatory agencies, and/or to support license negotiations for this product to parties for market rights outside of Shiseido's exclusive territory.
RepliCel has been working closely with Shiseido on the technology transfer and optimization of several features of the product's manufacturing.
RCH-01 is an autologous cell therapy uses dermal sheath cup (DSC) cells isolated from the hair follicle to treat androgenetic alopecia.
To manufacture RCH-01, dermal sheath cup cells are isolated from a small punch biopsy taken from the back of a subject's scalp. These cells are replicated in a GMP compliant cell production facility and the cells are then injected into balding areas on the same subject's scalp.
In clinical trials, after injections are performed, subjects return to the clinic at regular intervals for assessment of total, terminal and vellus hair density and cumulative hair thickness, as well as for safety and data collection.
About $3.5 billion was spent on hair loss treatments in 2015 according to The Washington Post. About $2.5 billion of this spent on surgical procedures, according to the International Society of Hair Restoration Surgery.
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|Title Annotation:||In The Clinic ...|
|Publication:||Stem Cell Business News|
|Date:||Jul 25, 2016|
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