RepliCel Life Sciences (OTCQB:REPCF; TSXV:RP; FRA:P6P2) has successfully completed its first-in-human clinical study of the company's autologous cell therapy for the treatment of androgenetic alopecia (pattern baldness).
The Phase 1 trial met its endpoints and sets the stage for next steps in ongoing research and development of its product, RCH-01, for the treatment of male and female androgenetic alopecia.
"As we march toward commercialization of this product based on this first-in-human data, our aim is to revolutionize the way we prevent, treat, and even reverse hair loss," president and CEO, Lee Buckler, said in a statement.
The five-year trial data set has confirmed the complete safety profile of a high-dose of dermal sheath cup cells (DSCC) for patients with pattern baldness due to androgenetic alopecia. No serious adverse events were reported over the entire 60.5-month follow-up period of the trial.
In addition, histopathological evaluation of injection site biopsies taken six, 12, and 24 months after injection did not reveal any pathology that was suggestive of tumour, granuloma or foreign body formation.
The seven top-tier responders in the trial saw a greater than 10% increase in hair density at six months post-injection. At 24 months, the average hair density increase for these same seven participants was 8.3% over baseline, and three of these seven trial participants maintained a greater than 10% increase in density over baseline. The largest increase in hair density over baseline observed in this group was a 21% increase at 24 months.
While there was a high degree of variability in hair density between individual participants at 24 months post-injection compared to baseline, an overall stabilization of hair loss was observed among all the patients treated per protocol.
"In summary, we are very pleased with the results of this first-in-human study and are excited to move this product forward into the next phases of development," Mr. Buckler said.