Intercytex has received many enquiries about
ICX-TRC and sincerely regrets that it is unable to
provide answers on an individual basis. In response,
however, this new web-page has been created to provide some
answers.
Please note: ICX-TRC is at an early stage of its development and
there are still many unknowns which will become clearer as the
clinical programme develops and the regulatory environment matures.
The answers given below are provided by Intercytex in good faith
based on current knowledge, but they are subject to change due to
clinical trial results, scientific research or other factors which
influence the development of new healthcare products. Therefore,
anyone reading the information below is asked to do so in the same
spirit and should not alter any current or future medication or
hair treatment plan as a result.
When this page is amended, an alert will be sent to
everyone who has registered via the
alert service, which can be
found on the upper navigation bar on the Home page of this
website.
1. When will ICX-TRC be on the market?
ICX-TRC is classified as a medicine by the regulatory authorities
and hence has to undergo a series of clinical trials before it can
be offered on the market, which will take a number of years to
complete.
2. How can I stay in touch with ICX-TRC’s progress?
Please watch our website for news and announcements about ICX-TRC
and sign up via the news alert
so you can stay up-to-date with our progress.
3. What are the results of the trials so far?
Results of the Phase I and II trials can be found
here and further information will be
published later in the year.
4. Will there be a Phase II or III trial in the US?
Phase III trials may be conducted in both the US and the UK but
plans to do so have not been finalised.
5. How can I take part in a clinical trial?
We do not currently have any trials underway, however we will
update the website with appropriate details when trial volunteers
are being sought.
6. How much will ICX-TRC cost?
It is too early to be able to determine the likely price.
7. Will ICX-TRC be available on the NHS or covered by insurance?
We don’t know if ICX-TRC will be available on the NHS,
however most procedures regarded as “cosmetic” are not
covered by NHS or medical insurance.
8. Will it be possible to grow a full head of hair using ICX-TRC?
Theoretically yes. If a person has enough hair at the back of the
head from which to take a small sample of cells, we believe that
ultimately it may be possible for their entire head to be
re-populated with hair using the procedure.
9. If I have had a transplant will it prevent me from using ICX-TRC
at a later date?
No, not at all. It may well be that ICX-TRC will work very well
with a transplant and could be used to “top-up” a
transplant if there is insufficient hair for a whole transplant to
be carried out.
10. Would I need several treatments with ICX-TRC?
ICX-TRC will not stop the natural process of hair loss so what you
might need is a series of “top-up” treatments over time
so that a full head of hair could always be maintained as you
continued to lose your own hair. We anticipate that only one small
biopsy would be required at the start though as the cells would be
cryopreserved and thawed as needed.
11. Would new hair grow in the same direction as the old?
In the ICX-TRC procedure we are not transplanting hair follicles,
instead we are implanting cells into the skin which induce new hair
growth, so there is no reason for these hairs to grow in a
different direction from before.
12. Could ICX-TRC be used to treat the hair loss found in alopecia
areata and totalis?
We do not know if ICX-TRC could be used to treat these conditions.
These conditions are thought to be caused by an autoimmune
mechanism. Since ICX-TRC is autologous (meaning it uses the
patient’s own cells) it may be that the underlying
autoimmunity might attack and destroy ICX-TRC cells just as it
attacked and destroyed intact hair follicle cells to cause the
initial hair loss.
13. Would new hair be resistant to the hormones that cause hair
loss in the first place?
Male pattern baldness, the most common type of hair loss, is caused
by hormones which generally affect the central and frontal areas of
hair but not the entire head. Hair at the back and sides remains
and it is cells from this part of the head – cells which are
resistant to the hormones, that are used in the ICX-TRC process.
14. Could ICX-TRC be used to treat female diffuse alopecia?
We hope so, and anticipate planning for future trials for female
diffuse alopecia.
15. Would it be possible to use donor hair for the ICX-TRC
procedure if for example, someone had lost all their hair, wanted
different coloured hair or a different textured hair?
In short the answers are maybe, no and no. The use of allogeneic or
donor cells is a long-term goal but it is many years away. The
colour of the hair comes from the epidermis and not the dermal
papilla cells so the cells that are cultured have no influence on
hair colour. Different textured hair would also require allogeneic
cells which is currently not possible.
16. How will ICX-TRC be administered?
ICX-TRC will be administered by a healthcare specialist; a
dermatologist, plastic surgeon or similarly qualified individual
who will need to take a biopsy (a small sample of cells from the
back of the patient’s head) during the first part of the
treatment and to inject cells into the patient’s scalp during
the second part of the procedure.
17. Does the ICX-TRC procedure result in the regeneration of
miniaturised follicles or the growth of new follicles (neogenesis)?
Studies indicate that both of these mechanisms may be active.
“Intrafollicular” implantation would take advantage of
the follicle structure retained by the miniaturised follicles
– these follicles would already be aligned in the appropriate
direction so rejuvenating or reactivating such pre-existing hairs
may be easier than forming new ones in the case of
"interfollicular” implantation. Intercytex is looking at both
neogenesis and regeneration.
Please click on the link below to access the following
publication:
Follicular Cell Implantation: An Emerging Cell Therapy for
Hair Loss by Jeff' Teumer PhD and Jerry Cooley MD, Seminars in
Plastic Surgery/Volume 19, Number 2, 2005
www.thieme-connect.com
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