The first in-human study of RepliCel Life Sciences Inc’s investigational baldness cure, RCH-01, confirms the therapy’s safety and demonstrates strong efficacy signals, the company reports.
The autologous cell therapy involves culturing a person’s own dermal sheath cup cells (DSCC) and then re-injecting them back into their scalp.
Next up are phase II trials as the new treatment continues its march toward potential commercialization.
The five-year trial data set has confirmed the complete safety profile of a high-dose of DSCC for patients with pattern baldness due to androgenetic alopecia. The long-term safety of DSCC injections was demonstrated through multiple physician, patient and independent measures of local and systemic tolerance including evaluation of adverse events with respect to causality, incidence, severity and seriousness. No serious adverse events were reported over the entire 60.5-month follow-up period of the trial.
Local injection tolerance was confirmed with only a few minor scalp irritations reported around injection sites that resolved quickly soon after injection. Furthermore, 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 study showed. An analysis of injection site biopsies taken 60.5 months after injection is currently ongoing with results expected in the next few weeks. Long-term systemic safety of RCH-01 was also confirmed as none of the systemic adverse events reported during the extended safety evaluation were related to treatment.
The trial was designed to gather data related to the product's potential efficacy through 24 months post-injection, but was not designed for statistical significance related to any efficacy endpoints. The efficacy data collected from all 19 patients, while not statistically significant, provides useful and potentially exciting insights into the product's potential for the treatment of those with androgenetic alopecia.
The seven top-tier responders in the trial saw >10 percent 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 percent over baseline, and three of these seven trial participants maintained a >10 percent increase in density over baseline. The largest increase in hair density over baseline observed in this group was a 21 percent increase at 24 months.
The top 10 participants reported at least a 5 percent or greater increase in hair density at six months post-injection with an average increase of 11.8 percent. This group demonstrated a sustained response at 24 months which averaged a 4.2 percent increase over baseline hair density. 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, the study showed.