FAQs

 

 

Q?

What is hair multiplication?

A.

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 miniaturising 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.

Q?

What is cryopreservation?

A.

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.

Q?

What are dermal papilla cells?

A.

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/

Q?

What is the hair follicle dermal papilla?

A.

The dermal papilla of the hair follicle follicle is a small “stud” of the dermis around which the mainly tubular indentation of the epidermis fits.  It is this tubular indentation that forms the hair follicle.

Q?

What is scientific innovation?

A.

Scientific innovation develops potential new therapies, often in isolation in the laboratory. The first time clinicians and patients are involved in any significant way is at the later stages of development during the clinical trial phase and by then the potential product is “fixed” and the link with the scientists is broken.  This means that clinical trials often fail, not because the product doesn’t work, but because the trial design was incorrect. The wrong patient group was tested or the wrong procedure was used to provide the product to the patient.  This is much more critical with products that use surgery of some form or another as it is the correct  combination of product and surgery that is needed.  Unfortunately, when this is the case, the investment funds are not available to learn from the trial and start again.  This has been the case with hair multiplication and it has resulted in several companies trying to develop hair cloning and then moving out of the field entirely.

Q?

What is medical innovation?

A.

Medical innovation involves clinicians and surgeons using their skill and best judgement to develop a therapy.  With this process, different procedures are tried and communicated to colleagues and there is the steady evolution of best practice.  This is indeed exactly how hair transplantation developed from plug grafts, to strip grafts to follicular unit extractions.

Q?

When will Hair Treatments be available?

A.

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

We are 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. Our first treatment will be aimed at repairing and rebuilding a patient’s miniaturising 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 so that patients can now bank follicles at our authorised procurement centres

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 and 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 hope that we can begin clinical trials proper as soon as clinicians determine a suitable treatment system.  It will take time to complete these trials and then apply for and obtain marketing licences 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.  Please keep checking the website and follow us on Facebook (#HairClone) and Twitter (@HairClone) to keep updated on our progress.

Q?

What is Hair Rejuvenation?

A.

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 miniaturise.  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 miniaturising 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 miniaturising hairs as the wave of hair miniaturisation progresses that it is possible that the appearance of the patient would be maintained.

Q?

What is Hair Regeneration?

A.

Although HairClone believes that early intervention can rejuvenate and rebuild miniaturising hairs (See Hair Rejuvenation), there comes a point where the hair follicle has miniaturised 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

Q?

What is cloning?

A.

Cloning is defined as “making a new copy of”.  It was originally intended to describe the process now being called “Hair Regeneration” or “Hair Multiplication”.

The aim, then as now, 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 miniaturising follicles or firstly allowing them to form organ rudiment structures before implanting with the aim of regenerating brand new follicles

 

Q?

How much will It cost?

A.

Together with “When will it be available” this is obviously the most asked question.
There are four elements to the costing

1) The surgical cost to extract the 100 follicles that will be used as a source of cells for producing both the rejuvenation and later the regeneration treatments

2) The cost to transport the follicles to the HairClone facility, test, cryopreserve and bank the follicles so that one surgical extraction can provide the starting material for several treatments when step 3) is developed

3) The cost to isolate and culture (clone) the cells and formulate the treatment

4) The surgical cost to inject or implant the cultured cells for rejuvenation or later the follicle rudiments or organoids for hair regeneration

The cost for step 1) depends on the particular HairClone partner clinic and whether this is done just to bank follicles or whether it is as part of a hair transplant procedure.

The current cost for step 2) the Follicle Banking is USD 2,000 or £1,700 which includes VAT, transportation, testing, cryopreservation and the first year’s banking.
After that, the cost will be USD150 or £120 per year to store the follicles.

We are working to develop the GMP cell culture system used in step 3) but it is too early to fix a price to that stage of the process and the cost of step 4) will depend on the particular HairClone partner clinic