ICX-RHY is a skin repair and rejuvenation product. It has been designed to improve the structure, function and appearance of skin damaged by medical conditions such as EB, scarring and associated scar contractures or the aging process. It is being developed primarily for medical applications but has also demonstrated utility in aesthetic applications
ICX-RHY is a suspension of human dermal fibroblasts (HDFs) in cell storage medium, for injection into the skin. When injected into the skin, the HDFs are believed to remodel and lay down collagen and other extracellular matrix within the dermis. An improvement should be apparent once the HDFs have begun to produce collagen.
ICX-RHY clinical and commercial development
1) A Phase I trial, conducted in collaboration with Professor Nicholas Lowe MD, FRCP at the Cranley Clinic, London, consisting of a placebo-controlled safety and tolerability study in ten healthy volunteers, has been completed. Each volunteer received a course of three injections given into the skin of the upper arm. ICX-RHY was shown to be very well tolerated; no serious adverse events were reported and all adverse events were transient and resolved without treatment.
2) A Phase II dose-escalation trial of ICX-RHY in nasolabial folds, also conducted at the Cranley Clinic, London has been completed. In this trial, six subjects received a low dose of ICX-RHY and a second group of ten subjects was treated with a higher dose. All subjects have been being followed out to six months post-treatment. The average satisfaction scores for both groups, as assessed separately by both patients and the investigator on a scale of one to ten (ten being the highest), were 7.8 and 7.6 eight respectively. In addition, the investigator measured an improvement in wrinkle severity in 12 subjects (75%) .
3) A second Phase II trial, for the use of ICX-RHY in acne scarring, conducted by Dr David Eccleston MB, ChB at the MediZen clinic in Birmingham, has been completed. Subjects were followed out to six months post-treatment. The average satisfaction scores for the treatment, as assessed separately by both subjects and the investigator on a scale of one to ten (ten being the highest), were 6.8 and 6.3 respectively.
4) A Phase IIa clinical trial for the use of ICX-RHY for the treatment of Dystrophic Epidermolysis Bullosa was carried out under Prof John McGrath and published in British Journal of Dermatology
Fibroblast cell therapy enhances initial healing in recessive dystrophic epidermolysis bullosa wounds: results of a randomized, vehicle-controlled trial.
5) Phase I/IIa clinical trial was carried out under Dr Peter Rubin at University of Pittsburgh to examine the use of IC-RHY to treat restrictive scar contractures and the results of this are in-press
No serious adverse events have been observed and the product has been well tolerated in all Phase II trials.
To date, over 100 patients have been treated for a variety of skin damage including acne scarring and wrinkles.