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 III

Indications

Androgenetic Alopecia

Partner

Highlights
In Asia, RCH-01 is being developed by Shiseido Company. RepliCel continues to own the rights exclusively for the rest of the world.
Currently the product is anticipated to launch while it continues to be developed elsewhere. Recently data was published (see below) from a phase 2 dose-finding study completed in Japan demonstrating best clinical results with the lowest tested dose. Plans are being developed for a next-phase study to answer important questions like: would results improve with an even lower dose than was tested in the phase 2 study and how many rounds of treatments are required to achieve optimal hair regeneration. 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 Clinical Overview

Recently RCH-01 was the subject of a clinical study conducted at Tokyo Medical University Hospital and Toho University Ohasi Medical Center, by Drs. Tsuboi and Niiyama. The study was financed by Shiseido Company and each product was 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. The study data from this randomized, placebo-controlled, double-blinded, dose-ranging clinical study of 65 patients (male and female) with pattern hair loss confirms, with statistical significance, the observations from RepliCel’s phase 1 trial in a larger cohort of patients including females, a wide variety of ages and hair loss, and compared with a placebo-control. In summary, the study produced a statistically significant and clinically meaningful increase in hair density and diameter as measured nine months after treatment. See further details here.

”Autologous Cell-based Therapy for Male and Female Pattern Hair Loss using Dermal Sheath Cup Cells: A Randomized Placebo-Controlled Double-Blinded Dose Finding Clinical Study”. American Academy of Dermatology. https://doi.org/10.1016/j.jaad.2020.02.033


Publications
Presentations
News
Hair Loss Study