HairClone Follicle Preservation with Sara Wasserbauer MD and California Hair Surgeon

Frequently Asked Questions:

We are the first tissue banking site outside of the UK to be able to offer these services, so obviously there will be many questions!  If you do not find your answer here, or just want more information, please call us at 925-939-4763.

WHAT DOES THE PROCESS OF CRYOPRESERVATION MEAN?

The hair follicles become frozen in time. For example, if the patient is 20 years old when he/she preserves their follicles, when a cloning treatment is available, the hair follicles will act as a 20 year old hair instead of a 50 year old hair.  This is important because the research to date has determined that at about age 45, hair starts to act “old” in the sense that it does not divide or grow as well and thus does not respond to the steps in the cloning process as robustly.  Cryopreserving hair NOW avoids this issue – like an “insurance plan” for your hair.

IS THIS A CLONING TREATMENT?

Unfortunately, no.  There are no cloning treatments currently available, but the details for removing and cryopreserving follicular units have already been developed so patients can use that part of the technology NOW.  There is over 40 years of basic research already to support this concept and the HairClone team have extensive experience in this area.  Although more scientific and clinical research is still needed before this concept can be fully developed, we believe that this could be a reality in 2-3 years.

HOW WILL THIS CONCEPT WORK?

Hair follicular units would be taken by an authorized and trained hair transplant surgeon under local anesthetic.  This would require the surgeon taking out the follicular units using a tiny punch extractor. The patient’s own hair should comfortably hide the harvest sites (tiny pinpoint scars) and he/she can go back to normal life almost immediately. Initially these follicular units would be cryopreserved and banked until needed.

When required, some of the follicular units would be taken from the bank and processed to isolate the specific cells involved in the production of the hair shaft itself.   These cells would be grown in culture in licensed laboratories and they would divide and multiply rapidly over 2-4 weeks.  These expanded cells would then be transported back to the clinic and micro-injected into the scalp where needed where they would be expected to migrate to miniaturizing follicles and rebuild the thinning vellus hairs causing them to produce thicker terminal hair shafts and regain a more youthful appearance.  In a later version of the product it is hoped that injected cells would be able to create brand new hair follicles by a process called follicle neogenesis for later transplantation.

WHAT DOES THE PROCEDURE ENTAIL?

Local anesthesia/numbing is used on the back of the scalp, but other than that no medications are required.  We do numb the back of the head so you may feel tiny pricks for a total of about 5 minutes of discomfort. No hair cuts or shaving are needed, we will trim the hairs that are taken. The grafts that are taken will be spread out so that the donor area still appears natural with tiny dot scars. The follicles will be sent and tested for viability once they reach the tissue bank. If a shipment is compromised Sara Wasserbauer MD will perform the harvesting and preservation procedure again at no cost to the patient.

WHAT BASIC RESEARCH HAS BEEN PERFORMED IN THE SCIENCE OF HAIR CLONING SO FAR?

Over 40 years of research have already been done and this research has enabled scientists to:

  • Remove the follicular units
  • Cryopreserve hair follicles
  • Cryobank cells for many years
  • Micro-dissect out the required cells from the hair follicle
  • Micro-inject follicle cells back into the scalp
  • Use specific monitoring systems to measure hair shaft thickness and hair density

By cryobanking your follicles, you will actually be supporting basic research to figure out the next main steps which include determining:

  • The best markers to use to measure hair follicle inductivity
  • The optimum system to expand cells in culture in order to maintain inductivity
  • The mechanisms by which re-implanted cells rejuvenate and regenerate hair follicles

I AM A YOUNG GUY, BUT HAIR LOSS RUNS IN MY FAMILY - SHOULD I BANK MY FOLLICLES NOW?

Banking now has several advantages:

  1. Banking at the earliest opportunity “stops the clock” on the banked follicles aging so the cells will be the most active when the treatment system is available, and you need treatment
  2. Banking allows multiple treatments from the one simple surgery
  3. Banking follicles is the first step and those patients with banked follicles will therefore be first in line for the treatment once it is available
  4. All profits from the banking will go to accelerating the development of the R&D to bring the treatment to the clinic
  5. Follicles remain the property of the patient and could be used for other treatments if the patient decides to transfer them

IS THIS THE SAME AS A “STEM CELL”TREATMENT?

Unfortunately, this is NOT a treatment – it is the first step in what will later be a process for treatment – but there are NO guarantees that a treatment will be developed, or that if one is developed it will work for every patient.  Hair is a naturally regenerating mini-organ. It goes through periods of growth, then resting, shedding and regeneration.  This process is controlled by a very specific group of stem-like cells at the base of the hair follicle called Dermal Papilla (DP) cells.  The number of these cells determines the thickness of the hair shaft that is produced by the sheath cells. A full thickness hair on the scalp is called a terminal hair. With some hairs, at each hair cycle the number of DP cells is reduced and the subsequent hair is thinner. Eventually, it is too thin to have a full cosmetic effect and is termed a vellus hair.

At the moment, there are no approved stem cell treatments for hair loss.  Research is ongoing, but nothing has been proven or approved yet.  Cloning as a concept for hair loss treatment would be better termed “Hair Regeneration” or “Hair Multiplication”.  The aim is to provide alternatives to supplement or replace hair transplantation.  HairClone believes that this can be achieved in one of two different ways, both of which firstly requires making new copies (cloning) a patients hair follicle cells and then either using them to rejuvenate and rebuild existing miniaturizing follicles or allowing them to form organ structures before implanting with the aim of regenerating brand new follicles.

HOW LONG DO THE FOLLICLES LAST IN THE TISSUE BANK?

We do not yet know an end date for cryopreserved tissue, but we DO know that tissue stays viable for at least 20-30 years – and it may be even longer than that.  Recall that this is new technology!  This has never been done before so time will tell…

WHAT IF I DO NOT WANT TO STORE MY FOLLICLES ANYMORE AFTER THEY HAVE BEEN CRYOPRESERVED?

You can stop having the follicles stored at any time. The follicles will be incinerated at that point.

HOW LONG DOES THE PROCEDURE TAKE FOR HAIRCLONE?

The procedure takes 60-90 minutes total.

HOW MANY FOLLICULAR UNITS/GRAFTS ARE TAKEN?

Approximately 50 follicular units/grafts.

IF SOMEONE BESIDES HAIRCLONE COMES UP WITH A TREATMENT BEFORE HAIRCLONE, CAN I USE THE FOLLICLES THAT WERE CRYOPRESERVED?

The patient can always use their tissue with the new company instead.

WHAT IS HAIR MULTIPLICATION?

Hair multiplication is another term for Hair Regeneration.  It has been proposed for many years as the ultimate treatment for hair loss. Hair transplantation successfully moves hairs from one region of the scalp to balding regions but is not able to increase the total number of hairs available. Hair multiplication would in effect, disassemble a few hair follicles, multiply these cells in the laboratory and then reintroduce them into the scalp to both rejuvenate miniaturizing hair follicles and induce brand new hairs. Other groups have tried this but it has been found that when human follicle cells are cultured, they rapidly lose their functionality and it is now generally accepted that hair multiplication/hair regeneration will require the formation of hair “rudiments” before implantation.  Several groups including HairClone are working actively in this area.

WHAT IS CRYOPRESERVATION?

Cryopreservation is a process where biological constructs are preserved by cooling to very low temperatures (typically -80 °C or -196 °C using). Cryopreservation methods seek to reach low temperatures without causing additional damage caused by the formation of ice during freezing. At low enough temperatures, any chemical activity in the cells is effectively stopped and at these low temperatures, cells can be stored for many years and if thawed correctly are then able to function normally.

WHAT ARE DERMAL PAPILLA CELLS?

Dermal papilla (DP) cells are mesenchymal cells that reside in the dermal papillae of the hair follicle. They are the focus of intense interest because the DP not only regulates hair follicle development and growth, but is also thought to be a reservoir of multi-potent stem cells.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3115771/

WHEN WILL HAIR TREATMENTS BE AVAILABLE?

This is the question that we are asked most frequently and it is very difficult to answer and we need to define what is meant by “treatment” and “available”.

HairClone is working on two different treatments that both use a patient’s own hair follicles to extract specific cells, expand (clone) them in a manufacturing system, and then subsequently return them to the patient’s scalp. The first treatment will be aimed at repairing and rebuilding a patient’s miniaturizing follicles (Hair Rejuvenation), returning them to their original dimensions and the second treatment will require the formation of hair rudiments before returning them to the patient and will be aimed at rebuilding brand new follicles (Hair Regeneration). This second treatment is much more challenging than merely rebuilding existing follicles and will take a lot longer to bring to the clinic.

In both cases, the first stage of developing the treatments will begin by extracting some follicles from a patient and cryopreserving the follicles so that the cells can be used when needed. HairClone are very proud to have launched the World’s first follicle banking service, and Sara Wasserbauer MD is very proud to be the FIRST outside HairClone’s own offices in the UK so that patients can now bank follicles at our authorized procurement center.

The next stage will involve developing a cloning system for follicle cells that could be used for Hair Rejuvenation and HairClone in partnership with the University of Newcastle has been awarded a grant to develop this system. We hope that around the end of 2020 HairClone will be able to offer a “Cell Expansion Service” to clinical partners for use in the UK.

We also hope to begin clinical trials as soon as clinicians determine a suitable treatment system.  It will take time to complete these trials and then apply for and obtain marketing licenses from the regulatory bodies before this becomes a routine clinical treatment around the world.  The management of HairClone, when in previous positions, have carried out over 19 different clinical trials around the world and have developed a variety of cell therapies that have treated around a million people so we have a huge amount of experience in this area.  We will do our utmost with the financial resources that we have to develop this therapy as quickly and efficiently as possible, but we will carry out each step ethically, with patient safety our top priority.

WHAT IS HAIR REJUVENATION?

During the process of hair loss due to androgenetic alopecia, cells are lost from the dermal papilla between two hair cycles, this results in the new follicle being smaller than the previous one which in turn leads to a thinner hair shaft and a shorter hair cycle. The hairs miniaturize.  This is a gradual process but eventually the long thick terminal hair becomes a small fine vellus hair and there is the appearance of hair loss.  HairClone believes that if the intervention occurs early enough then it is possible to add dermal papilla cells to these miniaturizing follicles and rebuild them, returning them to their original dimensions.  This is what HairClone is calling Hair Rejuvenation. 

There is pre-clinical and clinical data to support this concept and HairClone believes that by rebuilding miniaturizing hairs as the wave of hair miniaturization progresses that it is possible that the appearance of the patient would be maintained.

WHAT IS HAIR REGENERATION?

Although HairClone believes that early intervention can rejuvenate and rebuild miniaturizing hairs (See Hair Rejuvenation), there comes a point where the hair follicle has miniaturized so much that it cannot be rejuvenated.  These areas could be restored by hair transplantation but when insufficient hairs are available then treatment would require the regeneration of brand new hair follicles.  This is considerably more technically challenging than hair rejuvenation as an entirely new mini-organ needs to be produced.  HairClone is carrying out research in the development of hair rudiments that could possibly be implanted to create new hair follicles but this will take considerable development work before it is available.  Other groups are also working in this area and may have treatments available before HairClone.  Patients who had banked hair follicles with HairClone would be able to transfer these follicles to other groups for manufacture of treatments