more future hope

[giants]

is this similar to WNT proteins

 

 

 

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. How can I receive ICX-TRC?

ICX-TRC is currently in Phase II clinical trials in the UK, so it is not yet widely available.

 

2. 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. We currently estimate that the earliest that ICX-TRC would be available on the market is 2010 although we don't know in which country it will be launched first.

 

3. 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.

 

4. When will the Phase II trial be completed?

It is a rolling trial which will optimise the formulation and delivery as well as studying safety and efficacy. We expect some data will become available during 2007. We anticipate the current trial will complete during 2008.

 

5. Will there be a Phase II or III trial in the US?

At the moment the Phase II trial will be conducted in the UK only. Phase III trials may be conducted in both the US and the UK but plans to do so have not been finalised.

 

6. May I take part in the Phase II clinical trial?

The trials are being conducted at the Farjo Medical Centre in Manchester so all volunteers need to come from that area of the UK, partly for safety reasons but mainly because of their evaluation at the clinic for 48 weeks after the procedure has been undertaken. If you live in the Manchester area and would like to be considered for participation in the trial, please contact clinicaltrials@intercytex.com.

 

7. How much will ICX-TRC cost?

It is too early to be able to determine the likely price.

 

8. 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.

 

9. Do you have before and after photos?

There are no before or after pictures yet. This is because the first clinical trial, the Phase I trial, was to test for safety not efficacy. Although hair growth was observed, it was not the primary purpose of the trial.

 

10. 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.

 

11. 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.

 

12. 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.

 

13. 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.

 

14. 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.

 

15. 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.

 

16. Could ICX-TRC be used to treat female diffuse alopecia?

We hope so. If ICX-TRC is successful in Phase II trials for male pattern baldness, we plan to begin trials for female diffuse alopecia.

 

17. 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.

 

18. 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.

 

19. 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

[giants]

is this similar to WNT proteins

 

 

 

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. How can I receive ICX-TRC?

ICX-TRC is currently in Phase II clinical trials in the UK, so it is not yet widely available.

 

2. 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. We currently estimate that the earliest that ICX-TRC would be available on the market is 2010 although we don't know in which country it will be launched first.

 

3. 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.

 

4. When will the Phase II trial be completed?

It is a rolling trial which will optimise the formulation and delivery as well as studying safety and efficacy. We expect some data will become available during 2007. We anticipate the current trial will complete during 2008.

 

5. Will there be a Phase II or III trial in the US?

At the moment the Phase II trial will be conducted in the UK only. Phase III trials may be conducted in both the US and the UK but plans to do so have not been finalised.

 

6. May I take part in the Phase II clinical trial?

The trials are being conducted at the Farjo Medical Centre in Manchester so all volunteers need to come from that area of the UK, partly for safety reasons but mainly because of their evaluation at the clinic for 48 weeks after the procedure has been undertaken. If you live in the Manchester area and would like to be considered for participation in the trial, please contact clinicaltrials@intercytex.com.

 

7. How much will ICX-TRC cost?

It is too early to be able to determine the likely price.

 

8. 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.

 

9. Do you have before and after photos?

There are no before or after pictures yet. This is because the first clinical trial, the Phase I trial, was to test for safety not efficacy. Although hair growth was observed, it was not the primary purpose of the trial.

 

10. 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.

 

11. 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.

 

12. 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.

 

13. 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.

 

14. 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.

 

15. 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.

 

16. Could ICX-TRC be used to treat female diffuse alopecia?

We hope so. If ICX-TRC is successful in Phase II trials for male pattern baldness, we plan to begin trials for female diffuse alopecia.

 

17. 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.

 

18. 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.

 

19. 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

[Bill - Seemiller]

giants,

 

Excellent post.

 

Hair loss is being researched from two different perspectives as far as I can tell.

 

The first perspective is finding and curing the cause of hair loss by attacking it at the core. WNTs proteins and the signaling pathway is one such possibility in discovering the root "cause" of hair loss in order to find a cure.

 

The second perspective is hair regeneration or hair multiplication. This is a process in which dermal papilla (DP) cells (the cells responsible for the formation of new hair) are extracted from the donor "safe zone", are multiplied and than injected into the balding areas of a hair loss sufferer.

 

ICX-TRC hair regeneration is being developed by a company called Intercytex. It is currently in Phase II clinical trials in the UK. Preliminary results were expected the first half of 2007 - not sure if they are available yet). Interestingly enough - from what I have just read these trials are being conducted at Farjo Medical. Perhaps Mick McHugh (a consultant of the Farjo Clinic and poster in our community) can give us some more detail on this.

 

In a nutshell, this is how ICX-TRC hair regeneration therapy should work if it becomes approved for safety and efficacy...

 

Hair follicles and dermal papilla cells will be extracted from a patients scalp which will take approximately 30 minutes or so. These cells will then be sent to a lab and separated from the follicle. The lab will disassociate the DP cells from the follicle and will multiply them over a 3 week process.

 

The patient will return to the clinic in which time these cloned DP cells will then be injected into the recipient area and eventually grow on a similar timeline as a traditional hair transplant. Unlike a traditional hair transplant however, there will be no recipient sites made with a cutting instrument.

 

Interesting...

 

Bill

[giants]

so its a little different than what typical hair cloning will be like.

[Bill - Seemiller]

giants,

 

Well there is no such thing as typical hair cloning as it is not available yet. I would say that the above information provided above will become "typical hair cloning" if indeed it ever gets past the trial phases

 

Bill

[giants]

is there more than one company working on hair-cloning or is this the main one?

[Mick from Farjo]

Bill,

It's all hotting up again on this subject, the amount of interest generated is unbelievable. Although I hasten to add that I am not directly involved in this, I do have a closer link via Dr Farjo of course. At the moment phase 2 is continuing and more volunteers have been added to the program. However, I do know there have been some exciting developments. At the recent International Hair Research conference in Vancouver (where Dr Nilofer Farjo was invited speaker), Intercytex demonstrated growing hair follicles in the lab out of the multiplied cells (cloned cells). Dr Farjo says it's exciting because pending further research and trials it could mean the future is about planting hairs produced out of cloned cells rather than simply planting cells. He added that this would potentially make growth and aesthetics far more predictable.

I hope this adds a bit of light.

 

Mick

[Bill - Seemiller]

Mick,

 

Thanks for the update!

 

I think it's interesting that there is talk about having cloned follicles placed rather than the cells themselves.

 

Because I can't fathom how growth would be controlable by injecting cells alone into balding areas, I do arguably agree that growth and direction would be seemingly more controllable and predictable by transplanting clones hair follicles.

 

I'll be interested to hear more about best practices as time goes on.

 

If anyone else has any additional insight or thoughts regarding this topic, I encourage you to get involved and reply.

 

Cheers,

 

Bill

[giants]

its all real interesting stuff. It seems as though every balding person in the U.S.(and around the world) is waiting for cloning or something like it. With this much interest and the rewards that come with cloning I would not be suprosed if it actually happens within the next 5 years.

[EmuSteve]

This is all very interesting. Watch me finally take the HT plunge and then, the next day, Intercytex announces that Hair Multiplication is now available. =)

 

I know, however, that Bill makes a great point. I remember when I was researching this, a lot of people were saying that this type of procedure would be best paired with a traditional HT. This is because you want the hairline to look very natural by controlling the angle and direction of the hairs, and HM would be used more as "filler" behind that.

 

I know Bosley has a split-off called Aderans that is trying to do the same thing, although if I had to buy stock, I would definately put it in ICX.

 

Speaking of which, is ICX available on the stock exchange? Invest $1000 today in ICX, and if they succeed with Hair Multiplication, you know you are going to make enough back to pay for your HM procedure and then some. The demand for this is huge.

[giants]

It also looks as though cloning will not cost as much as espected. Looks to be around 10-20,000

[giants]

Im sorry that cost i posted is false. I got that from an unreliable source

[calvinmd]

The issue of whether ICX's stuff regenerates existing follicles or regrows new ones might be VERY important.

 

If you've had most of your bald head area surgically worked on during previous HT procedures, then you might benefit from this a lot less than others. Your donor wouldn't really have many "dead" follicles to revive, and the MPB'd follicles in your bald areas would probably have suffered a hell of a lot of damage from the past HT procedures.

 

 

 

I can't believe they're this far into the game, and they still don't have a clear-cut answer for such a basic question.

 

 

------------------------------------------------

[Bill - Seemiller]

Calvin,

 

You bring up a good point. It will be interesting to see the future of hair regeneration and where it leads.

 

Bill

[calvinmd]

Thanks Bill.

 

Although even if the ICX method can only regrow existing follicles, I'll bet it would probably still be able to sprout up the equvalent of several thousand new grafts for almost anyone. Existing HTs are gonna do some sizable damage for sure, but it's not like EVERYTHING up on top is gonna be transected. Nature's original no-MPB density is so high that we'd probably all see good visible density gains from reviving even 1/4 of those follicles.

 

Not to mention the thickening of existing hairs that this procedure will probably cause, since MPB often causes minor thinning even in the "permanent" zones. So any hair-thickening results of ICX's treatments will be like gaining some grafts for free.

 

 

 

I don't think the new vs. revived grafts issue itself is occupying my mind half as much as the fact that they don't seem to have an answer to the question.

 

What is it about hair researchers? They're all so committed to the problem, and yet they always seem to leave huge surprising gaps in the knowledge whenever I read about what they're doing. Seems like no matter what I'm reading about hair research, I always come away at least a little bewildered at the way they're going about it.

 

 

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