Hair Restoration Blog

Q:

Comment or Question: is hair cloneing/multiplication currently available at your practice? please leave a voice mail

A:

Hair multiplication is not available at our hair transplant centers or any other hair restoration clinic for that matter because present-day technology has not yet been able to successfully multiply hair for the purpose of hair restoration.

But there have been numerous studies and publications on hair multiplication, also known as hair cloning. And there is one company, Intercytex, , which has been considered by many experts to be at the forefront of hair multiplication research.

Intercytex announced that their staff finished phase II of the study and started phase III (the stage in which scientists try their particular product and method on a large number of people and follow them for eight to 10 years and wait and see if there are significant long-term side effects and complications to take into account).

However, at the last annual meeting of the International Society of Hair Restoration Surgery (ISHRS), it was announced that Intercytex hadn’t even successfully completed phase II of the study, which means phase III hasn’t been started. We don’t know which specific obstacles impeded the progress of this work, but we are aware that it generally takes about eight years for phase III of most studies to be completed.

So, the research might get started in about eight years, maybe longer, after which we may find hair multiplication proven to be safe and effective.

People ask about hair multiplication, hair loss, stem cell hair regrowth, and hair cloning transplant all the time.  The last annual meeting of the International Society of Hair Restoration Surgery (ISHRS), where all authorities in medical hair restoration get together, did not have any good news for the people who are eagerly following the progress of hair multiplication research.  In fact, the newly disclosed information from Intercytex who is considered the leading group working on hair multiplication revealed that they never successfully finished phase II of their study on hair follicle multiplication.

This is contradicting with what they released previously regarding completion of phase II and the commencement of phase III.  This is considered a step back in the field of hair restoration and it means a longer waiting time for people who are impatiently waiting for hair multiplication to become a reality.

When any new treatment modality is being researched, scientists need to go through several phases to establish its effectiveness and safety.  Phase III of a study is when a few subjects (human) are being treated with the new modality on a longer period of time to assure the long term effect and safety of the new treatment.

The reason for the delay in completion of phase II of hair multiplication research was not fully disclosed.  However, knowing this fact leads us to believe that using multiplied hair won’t be possible at least in the next 8 years.  We at US Hair Restoration are collaborating with the academic center in some different stem cell hair research.  Our research is still in its early stages, but we will release our findings of this hair stem cell research as soon as they are available.

Yes, I am  back from Amsterdam.  I spent one week there and I was mostly involved with the meetings of the International Society of Hair Restoration Surgery.  The city of Amsterdam was beautiful and I still cannot believe in this day and age people still bike to work on a regular basis in a capital city in Europe.

As always of every year, we had a large number of hair transplant surgeons come from all over the world. My lecture this year was on a new application for the Laxometer and the title was Laxometer and Sequential Strip Removal for Increasing the Safety of Strip Removal in Mega-session Hair Transplants.  We will be placing a summary of the lecture in the hair loss library on our website US Hair Restoration soon.

The research results that was presented by the consultant of Intercytex for hair multiplication was disappointing and basically despite the fact that they announced they started Phase III of the study, this year they said they have not even finished the II yet.  They claimed financial problems to be the cause of that.  We will look closely as we were before to see what is going to be out in the horizon for hair multiplication or as it is often called “hair cloning”.

Several new automated techniques were also introduced for FUE harvesting but I was not impressed by any of those.  It seems like no one could come up with an ideal technique for the automated FUE that does not have significant problems.  We will continue with the manual methods for FUE hair transplant graft removal and placement at this time.

There were many nice discussions on new techniques in making sites, closing the donor wound and preparation of the hair transplant grafts.  The aesthetic aspects of hair restoration surgery was also discussed in many sessions and nice new concepts were introduced by several doctors.  Hairline design and temple points were again discussed and it seems that more doctors are realizing the importance of restoration on hair in the temple areas.  We at US Hair Restoration are very big in restoration of the temple points in the patients that need it and temple hairline is a necessary part of our hair restoration and hairline designs.

The comparison of the maintaining solutions is always part of the discussions.  This year there were a few nice comparative researches on densely packed hair and also the comparison of the grouping of the hair grafts in follicular unit form or isolate single hair groups.

Hair Restoration is one of the young fields of cosmetic surgery.  It has been revolutionized in the last 10 years with development of the idea of follicular unit transplantation and stereotactic microscopy that gave us the capability of producing such great results that are undetectable from the natural hair.  Presence of hair transplant doctors in scientific meetings of this kind help the hair transplant surgeon to be able to deliver the highest standard of hair transplant to his patient that can eventually guarantee both the doctor and the patient satisfaction.  I recommend the meeting of ISHRS to every doctor who performs hair transplant surgery as a big part of his practice.  In fact I do not understand how some doctors can afford not to be there while new findings are changing the face of hair restoration medicine on a regular basis.

Q:

I would like to ask Dr. Mohebi about hair stem cell research. If you can explain what it is, how long has it been in research, and in what phase it is at this moment? I’m 31and notice that I had AU, around the age of 29-30. At the time I was going through a lot of stress that made me feel like I’ve brought this on myself. I was taking treatment injections for my eyebrows to see if I can at least save my eye brows. Well, I got tired of the injections, and just left it in the hands of the Creator. Are there eyebrow and eyelash replacement that can be obtain and if so where? I just had a little girl and I really want to take some decent pictures with her and it bothers me at times that I can’t even do that, so I can relate to all who are going through the up’s an down’s and the fight within and without to BEAT-AU, and others. I guess only time will tell.

A:

Hair stem cell research is becoming very promising for treatment of many types of hair loss. Phase 3 of the study on hair multiplication was started about 3 years ago and it is still ongoing. The purpose of phase three study of any new treatment modality is to prove that there are no long term side effects on the volunteer patients who undergo any new treatment. Hair stem cell technology seems to be a real therapeutic option for many types of hair loss conditions for the next 5 to 10 years.

Having said that, some details about the process of hair multiplication is not quite clear yet. There is not much information released on the quality of multiplied hair and we are not quite aware about the final cost of the procedure. When it comes to AU (Alopecia Universalis) we cannot know for a fact that hair multiplication is the answer to this condition considering the mechanism of AU and the fact that the patient’s own immune system tends to destroy hair follicles.

It is likely that multiplied hair follicles have the same antigenic properties so they could be recognized by the immune system and destroyed the same way that the native hair was initially. A combination of some sort of anti-immune treatment and transplanting multiplied hair might be the answer, but we cannot know for sure before they are investigated thoroughly in the future.

“Formation of Hair Structures Suitable for Implantation” is the title of a newly published article from Intercytex. Hair multiplication, also known as hair cloning, has been discussed in our Hair Restoration Blog in many of our past posts and has been the subject of many studies in the past. Intercytex is one of the companies that have been reporting some progress in different levels of the study and have reported that they have finished phase II and are starting phase III of this study.

Their studies have shown that hair multiplication by hair culturing has been successful in animals and it is now being studied on humans. The following article tries to elucidate the process of hair multiplication on laboratory animals that have already been released.

The aim of the study was “to develop a construct through which implanted follicular cells will efficiently cause hair regeneration for the treatment of androgenetic alopecia.” They used follicular dermal and epidermal cells isolated from embryonic mouse skin which were formed into aggregates.

The aggregates were incubated in lab in culture for five to seven days and then implanted inside the skin into athymic mice, which does not have the capability of rejecting foreign tissue. They observed that during culturing, mixed cell aggregates developed into hair-like structures, termed “proto-hairs.” Proto-hairs contained structures that resembled normal hair components, such as dermal papillae, hair matrix and rudimentary hair shafts.

When implanted into mouse skin, they developed further into mature hair follicles capable of prolonged growth. The authors concluded that mixed aggregates of murine follicular cells have the ability to develop while in culture into proto-hairs that retain the ability to fully develop into hair follicles after implantation.

Proto-hairs from human hair stem cells could provide a convenient and practical means by which follicular cells could be implanted for efficient hair regeneration to treat hair loss. Although the study does not add to what we knew before, it elucidates the process of work for the other scientists who follow on the progress of hair multiplication (cloning) research.

We at US Hair Restoration California offices follow the progress of hair multiplication studies closely.  We are also involved in some hair multiplication studies and the results will be released when completed.

Q:

I have had alopecia areata since I was 3 years of age and now I’m 33. I have done as much research as I can to find the causes of this hair loss and there has not been any accurate information of the cause. But my question would be if you are cloning the hair and a patient has alopecia how successful will the procedure be if the hair growth from the patient is unhealthy in the first place?

This procedure is a billion to trillion dollar industry but the research has to be done extensively due to unknown side effects. Please keep posting more information as you go forward. There are many people waiting impatiently.

A:

Alopecia areata is one of those conditions that hair transplant, either from regular methods or through cloning, cannot help much. We have discussed the treatment options for alopecia areata on our website.  Alopecia areata is an autoimmune condition in which the immune system reacts against the hair follicles and destroys them.

If we were to transplant hair to an area with active hair loss due to alopecia areata, the chance of you losing the transplanted hair is very high due to the same mechanism in which native hair has been lost. We do not have much information on cloned hair, but the same phenomenon is likely to happen after transplanting cloned or multiplied hair.

Intercytex has recently released some information on its hair multiplication experiments in a new article in the Journal of experimental dermatology. The title is “A graft model for hair development” and the article discusses what is done so far for hair multiplication experimentally. Intercytex has been involved with hair stem cell, hair culturing and hair multiplication, which is also known as hair cloning.

In this article follicular cell implantation (FCI) is discussed as an experimental cell therapy for the treatment of hair loss that uses cultured hair follicle cells to induce new hair formation. The process of culturing hair cells is based on the demonstration that adult dermal papilla cells (DPC) retain the hair inductive potential that they acquired during hair morphogenesis before birth. To obtain FCI, the investigators isolated hair inductive cells from scalp biopsies and then propagated them in culture media in order to provide adequate cells to generate several new follicles from a few hair follicles.

Following expansion of cells in culture, they implanted those cells into the scalp where they induce the formation of new follicles below the level of skin. They describe a consistent, reliable method in which they can test hair induction. Since the process relies on the ability to retain the potential for hair induction during the expansion of DPC in culture.

They go over a simple graft model that supports hair morphogenesis. In this experiment, they combine dermal cells with embryonic mouse epidermis that provides the keratinocyte (one of the skin cells) component of induced follicles. The grafts are placed under a protective skin flap in the host athymic mouse (a special mouse without capability to reject the transplanted grafts from human) where the cells will form a skin graft with hair if the dermal cells are hair inductive DPC.

Using the assay freshly isolated and cultured mouse embryo dermal cells as well as cultured dermal papilla cells from other species all induced hair formation. They also showed that induced hairs were aesthetically indistinguishable from those of the epidermal donor in length, thickness, and pigmentation. The investigators stated that the newly formed hairs were histologically normal and could resemble a complete natural hair.

We at Los Angeles hair transplant surgery centers of US Hair Restoration will closely follow up with the progress of hair multiplication and cloning techniques. Although the result of the cultured hair on animals has been released before, the current released article is interesting and elucidates more on the characteristics of cultured hair during the process of hair multiplication so called hair cloning. It seems like we still have a long way to go till we can practically use hair multiplication techniques in restoring human hair.

Recently published in the Journal of Medical Hypotheses was an interesting article on the treatment of alopecia by transplantation of hair follicle stem cells and dermal papilla cells (the cells of the bottom of hair follicles) in alginate gels (media used for cell transplantation).

A group of scientists at regeneration lab of tissue engineering, Department of Bioscience of life science in Northwest University of China authored this article. They proposed a system to use the two important hair stem cells to form mature hair in people with hair loss. They explain that the discovery of hair follicle stem cells (FSC) brings gospel to the affected individual of hair loss because of its capacity of generating new hair when they interact with mesenchymal dermal papilla cells (DPC).

The above two cells are known as the necessary cells for formation of new hair. Since both FSC and DPC have strong proliferative capacity and the patient’s own cells could be expanded considerably in vitro, they hypothesize that the microencapsulation of the two kinds of cells in alginate gels could be implanted into the bald scalp of the patient since alginate gels is effective in cell transplantation. They concluded that the strategy may provide a more convenient and valid alternative to hair loss if the hypothesis proved to be practical.

Here at Los Angeles hair transplant office of US Hair Restoration, we follow the most recent findings on the field hair hair stem cell research or hair multiplication also known as hair cloning. The above theory sounds logical and seems to be simple. However, until it is experimented in the lab and then on life creatures we cannot know how practical it may be. It seems like the race to use hair stem cell for the treatment of men hair loss is started.

Q:

Thanks for the serious information.

I hope they find the hair cloning or something that generates hair follicles in a near future. My question is if this cloned hair would fall or if it is going to be like the donor hair that doesn´´t fall because of it imunnity to dht. I would aprecciatte your answer.

A:

This is a great question and unfortunately we still don’t have a clear answer to it. The problem is most research projects on this topic have been limited in terms of numbers and long term follow up. Intercytex is a biotechnology company that probably has the most promising project on hair multiplication at this point. They have done some studies and finished phase I of a hair multiplication study. Unfortunately the details of their research have not been announced quite clearly. However they announced that they will release some more information in September of 2008. Let’s wait and hope that they clarify some of those issues and answer the questions like yours on the quality and durability of multiplied hair.

Best,

Dr. Mohebi

Autologous Hair Regeneration - ICX-TRC (Intercytex)

ICX-TRC is an autologous hair regeneration system. ICX-TRC project is an ongoing research program that uses a suspension of human dermal papilla cells (one of the stem cells of the hair follicle which is involved in the growth and cycling of hair follicles. The system is claimed to be used for the treatment of male and female patterned baldness. The intention of ICX-TRC is to provide a technique to restore hair in patients who do not have adequate supply of donor hair on scalp for the hair transplant process and maybe for everyone with baldness.

Both types of patterned hair loss have significant genetic influence. It was claimed that with the ICX-TRC procedure, the process of hair restoration would be less problematic than conventional hair transplants. The proposed idea is to remove a few normal hair follicles from the donor area and harvest their active cells called dermal papilla (DP). These active cells are cultured and multiplied by different techniques and eventually the multiplied cells from this culturing process could be used to produce multiple hair follicles. The goal is to grow the hair follicles that are produced with this method while keeping the original characteristics of donor hair.

The cultured cells are supposed to be injected to the bald areas of skin. Interaction between the DP cells and normal epithelial cells in the skin can potentially generate new hair follicles under a certain circumstances. The process of culturing the DP cells and getting the new cells may last around three weeks.

Intra-dermal injections of new DP cells in the scalp could be done under local anesthesia with the current techniques of hair transplantation. It is claimed that some sort of hair growth could be seen after 3 months. However the condition and characteristics of the new hairs have not completely elucidated.

ICX-TRC clinical trial

Every new medication or medical technique needs to be examined closely through a systematic process for evaluating its effectiveness and safety. Intercytex has announced that they have finished their phase I (for safety and tolerability of the system) on volunteer patients and it has been successful. It means that the procedures did not have a serious or lethal side effects, at least in short term.

They also announced that they started phase II in Manchester to optimize the delivery of the DP cells and to refine their techniques, which is completed as well. They have obtained hair and measured the growth by shaving and taking photos of the transplanted area with cultured DP cells. On the phase II of the study they used 19 volunteer. They describe few different techniques that were used including pre-stimulation of the skin before injection of the cultured cells. Unfortunately, there is not much information available on the technique and methodology of the studies.

Here is what is stated in Intercytex web site for the result of the phase 2 of this experiment:

• Eleven subjects have now passed the 24-week time point since treatment and specialized image analysis at this time point showed
• Of the group of six patients without stimulation of the scalp, three had an increased hair count and two had a reduced hair count; one has been lost to follow-up
• Of the five subjects with pre-treatment scalp stimulation, all had increased hair count at 12 weeks and the three who were evaluable at 24 weeks all had an increased hair count at that time point

They are still looking for the 24 week data on all subjects in September 2008. At that time if it is all promising we should expect to see the phase III started on a larger group of patients who try this treatment for a longer period of time (years) to rule out any long term complications.

Intercytex is also claimed that they are working on an automated device that can facilitate the injections of cultured grafts, which could be used for the transplantation of cultured hair cells.

Conclusions:

1. The progress of Intercytex research and the released results are not quite clear yet
2. The safety of this system has not yet evaluated for long term potential side effects of cultured human cells such as increased risk of cancer or other dermatologic or systemic abnormalities
3. If proven safe and effective after completion of the phase III, we should have an estimate of the cost for this procedure. It is unclear whether or not this is going to be affordable and something that could be used for everyone or it should be reserved for patients with special needs.

We will follow the progress of ICX-TRC project along with other similar projects on hair stem cell and hair multiplication studies and keep our readers posted.