ICX-TRC
Text from Intercytex' site:
- ICX-TRC is an autologous hair regeneration therapy intended for the treatment of male pattern baldness and female diffuse alopecia.
- A small sample of hair follicles is taken from the patient during a simple 30 minute operation carried out under local anaesthetic at a hair or skin clinic. The clinic will send the biopsy to Intercytex’ manufacturing facility where the hair-inductive dermal papilla cells are dissociated from the rest of the follicle. These cells are cultured and expanded in proprietary media over three weeks and subsequently returned to the clinic in a sterile suspension. Using a specialised delivery system, the hair-inductive dermal papilla cells are microinjected intradermally into the patient’s scalp. The treatment is performed under local anaesthetic and comprises a single procedure of superficial injections, each injection delivering a minute volume of media containing dermal papilla cells capable of inducing new hair growth. Following the procedure, new hair growth should become evident after approximately three months.
- Intercytex is developing a robotic system with The Automation Partnership for the commercial-scale production of patients’ autologous dermal papilla (DP) cells. The robotic system has an established track record in processing many different cell samples simultaneously. It is vital that at this scale, in which a large numbers of different patients’ cells are handled, that all samples remain isolated throughout the multiplication process.
- It is intended that ICX-TRC will be used by specialists in hair transplant centres, dermatologists and plastic surgeons to treat patients with hair thinning or hair loss.
- Intercytex will initially develop ICX-TRC to treat male pattern baldness and expand the indication to include treatment of female diffuse alopecia.
- Phase I clinical trials (safety) have been completed in seven volunteers at a single UK transplant centre. No safety issues have arisen and five out of the seven patients have shown increased hair numbers. Recruitment for Phase II clinical efficacy trial on patients with male pattern baldness has commenced in the UK with an initial cohort of up to 20 subjects which will be followed by variations in delivery technique in further similar sized cohorts. The trial is designed to demonstrate efficacy of ICX-TRC, the dosage regime and the delivery device. Preliminary data from this trial are expected during the first half of 2007.
[edit] ICX-TRC vs Traditional Hair Transplant
| Conventional transplant | ICX-TRC procedure |
|---|---|
| Extensive donor tissue removal (2,000 – 5,000 follicles) | Minimal donor tissue removal (approximately 120 follicles) |
| Donor site is large – an ellipse or slice of scalp is removed and scarring results | Donor site is small – a single biopsy with a minimal scar site |
| Two operations of eight hours each, to remove scalp, dissect hair follicles and re-implant into surgically created cavities | 30minute operation to takebiopsy and approximately two hours intradermal microinjection of dermal papilla cells |
| Lengthy recovery time, pain, bleeding and swelling during and after implantation | Negligible recovery time;minimal pain, bleeding and swelling during and after microinjection |
| Final outcome is limited to amount of donor hair available – there may be insufficient transplantable hair follicles | Repeat procedures possible from a single biopsy |
| Currently unregulated | Regulated |