The Autologous Dermal Filler:
Khorionyx keeps the insoluble character of globin at neutral pH, with the following process. A 10ml blood sample is drawn from the patient, the red cells are purified by centrifugation and the red color of the heme is removed. 8ml of an 8% globin precipitate are prepared by suspension of the purified globin in a physiological phosphate buffered saline (PBS). The whitish paste thus formed is directly sterile and can be injected through the finest hypodermic needle (30g), without any other chemical additive.
The Autologous Dermal Filler
A more concentrated paste (10 to 15%) can be prepared for specific applications. The high purity of globin was demonstrated by SDS PAGE electrophoresis and Western Blot analysis.
The originality and the advantages of this natural protein are numerous :
- It gives an insoluble paste which can easily be prepared in 1 hour from any patient;
- It has undergone no alteration or chemical modification;
- It is completely biocompatible with the surrounding tissues into which it is injected;
- The insoluble nature of globin in a physiological environment explains its persistence after tissue implantation and its resistance to enzymatic degradation, especially if the amount injected is important;
- A protein paste of human globin could be used in humans for filling skin cavities, wrinkles or scars, or augmenting the volume of other tissues (urinary or digestive sphincters, vocal chords, etc.).
The filling applications permitted by the globin paste are therefore numerous and the augmentation of wrinkles is just the first application we want to test before developing other medical applications, like healing of chronic wounds, bone or cartilage defects.
Khorionyx has access to ISO or FDA certified subcontractors for manufacturing its prototypes and new products. All the technical documentation is ready for submission to different National Health Authorities, in order to get the approval to start pilot and pivotal clinical studies.