There is an increasing amount of scientific evidence that would indicate that hair cells and hair transplant quality decreases with age. Therefore, harvesting and banking hair cells at an early age will be expected to preserve high cell potency for future uses.
What is the benefit of banking?
The steps from hair donation to cell cryopreservation are already developed so banking now puts these patients “first in line” for transplantation of their hair cells. Moreover, the HairClone concept will not stop the underlying thinning process so will need to be repeated every 2-3 years in order to maintain hair density as the patient’s own hair thins. The banking activities could start within a year and will create a patient pool and short-term revenue to the company which will help support the clinical and product development and bring it closer to clinical reality. The banking will allow as well development of licensed GMP processes ahead of marketing license for the expanded cell therapy which would be regulated by the European Medicine’s Agency (EMA) as an Advanced Therapy Medicinal Product (ATMP) and By the U.S’s Food and Drug Administration (FDA) as a Biologic.
Exciting and rapid progress in developmental biology will provide the scientific basis for this ground breaking new treatment and we expect that this could be in the clinic within the next few years although it will take several years before it is fully licensed around the world.