Product Detail

RCH-01

FOR Regrowing Hair

RCH-01 is an autologous cell therapy utilizing dermal sheath cup (DSC) cells isolated from the hair follicle to treat androgenetic alopecia.

Though several cell types are involved, dermal sheath cup cells, located at base of the hair follicle, regulate the growth of hair fibres in the follicle. For those people suffering from androgenetic alopecia, the DHT hormone attacks these cells and as they disappear so does the hair fibre. At the back of the head, however, these cells are immune to the condition.

RCH-01 is made up primarily of dermal sheath cup cells which are immune to androgenetic alopecia. These cells are isolated from a small tissue sample taken from the back of the patient’s scalp and used to grow millions more of these cells which are then reintroduced into balding areas on the subject’s scalp.

Product Status

Phase

Clinical Phase II

Indications

Androgenetic Alopecia

Partner

Shiseido Company (Asia)

Highlights
RCH-01 is being co-developed by Shiseido Company and RepliCel in Asia and by RepliCel in the rest of the world. Under Shiseido's management, the product is anticipated to launch first in Japan while it continues to be developed elsewhere.

RepliCel is planning a Phase 2 trial to answer important questions like: what is the best dose (number of cells) to see intended results and how many rounds of treatments are required to achieve intended results. Trial success will be measured by assessing changes in terminal and vellus hair density as well as cumulative hair thickness over a period at least one year.

Clinical Data

RCH-01 Clinical Overview

RCH-01 is under clinical investigation at Tokyo Medical University Hospital and Toho University Ohasi Medical Center, by Drs. Tsuboi and Niiyama. The study is being financed by Shiseido Company and each product 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.

Hair Loss Study