Hair Restoration Blog

“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. Intecytex 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.

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.

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.

Q:

Is Hair cloning or multiplication being done anywhere yet?

A:

Hair cloning or multiplication has been in the news in the last few years. I prefer to use tem “hair multiplication” rather than cloning because cloning refers to production of genetically identical organisms. Dolly the most celebrated sheep was the product of first cloning. When it comes to hair, we do not really clone the cells, but we culture them and try to get a whole organism from cultured cells. Unfortunately the process of culturing hair follicle cells has not been as simple as some other tissues in human body. The complexity of hair physiology is due to participation of many different stem cells in development of each hair follicle. In this process, we do not multiply genetic material or DNA of cells.

Hair cloning news

Hair multiplication if become a reality could bring about a great opportunity for bald people with violated donor scalp who cannot be good candidates for hair transplantation with current techniques. Despite our enthusiasm about hair multiplication, hair cloning news in last few years has not been filled with many success stories.

Hair cloning 2007

Year 2006 intercytex company announced that they are going to start phase 3 of hair multiplication study soon. Hair cloning has been in the news and many people are eagerly following that news to see when and how they can get a full head of hair using hair cloning techniques. Unfortunately, cloning hair has not been going that well and in last few years we only had limited research results on hair multiplication in animal models and in human. Here is the question that people usually ask me:” Is hair cloning being done anywhere yet?” My answer is: Not except on experimental levels. Several investigations are in process on hair multiplication field and hair stem cell research.

Hair cloning 2008

Hair multiplication or as people call it hair cloning is a method that allows us to culture hair follicles and multiply it so we can increase the final number of hairs. So far, we know that it is doable on animals, and there are some reports of its feasibility on human volunteers. Safety has been one of the biggest questions on any research involved with stem cells. Stimulating growth of stem cells has always raised the flag for possible tumor formation. In year 2008, we should witness some results of the phase 3 studies on the procedure. During this year or in next few years, we should have a better understanding of the effectiveness and safety of hair multiplication. I know many of my patients are following hair cloning news carefully. Unfortunately, hair multiplication news has not been very fruitful in last year, but the process is complex and one way or another it will become clear in next few years that we can or cannot use hair multiplication methods in hair restoration surgeries.