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 material is preserved by cooling to very low temperatures (typically -80 °C or -196 °C). Cryopreservation methods seek to reach low temperatures without the formation of damaging ice crystals during freezing. At low enough temperatures, any chemical activity in the cells is effectively stopped and cells enter a state of ‘suspended animation’. At these low temperatures, cells can be stored for many years and if thawed correctly are then able to resume normal function.

Q?

What are dermal papilla cells?

A.

Dermal papilla (DP) cells are mesenchymal cells that reside in the dermal papillae of the hair follicle (See What is the dermal papilla). 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 that can rebuild follicles.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3115771/

Q?

What is the hair follicle dermal papilla?

A.

The dermal papilla (DP) is a small pouch of cells found at the base of the hair follicle. It 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.

The number of dermal papilla cells is directly proportional to the hair diameter. The loss of DP cells over time is the cause of hair miniaturisation during the progression of androgenetic alopecia. The basis of HairClone’s rejuvenation treatment is to multiply DP cells and inject them back into the scalp to restore DP cell number and rebuild follicles.

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. HairClone aim to use this approach to optimise the clinical application of our treatment before embarking on clinical trials. This is made possible by special UK legislation set out by the Medicines and Healthcare products Regulatory Agency (MHRA).

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”.

Our primary rejuvenation treatment requires the extraction of follicles, multiplication (cloning) of cells and injection back into the scalp. The initial step of extracting and storing follicles is already live, following HairClone’s launch of the World’s first follicle banking service. Patients can now bank follicles through one of our procurement centres. This allows immediate access to follicles when required.

The second stage involves multiplying dermal papilla cells. HairClone has developed a partnership with a GMP manufacturing facility at the University of Newcastle, where HairClone’s cell culturing technology has been transferred. This will allow HairClone to offer a “Cell Expansion Service” to clinical partners for use in the UK, hopefully within 2022.

In order to market our treatment, we must carry out clinical trials as soon as clinicians determine the most effective 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; however, our “Cell Expansion Service” will remain active in the UK.

Our second, regenerative 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 many years longer to bring to the clinic.

HairClone’s management, 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 over 2 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.

Hair rejuvenation refers to rebuilding miniaturising follicles and returning them to their original dimensions.

Androgenetic alopecia causes cells to be lost from the dermal papilla between 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. Hairs become miniaturised over consecutive hair cycles, giving the appearance of hair loss.

Eventually, the long thick terminal hair becomes a small fine vellus hair.  HairClone believes that if our cell therapy intervention occurs early enough, 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 hairs as the wave of hair miniaturisation progresses that it is possible for the appearance of the patient to be maintained.

Q?

What is Hair Regeneration?

A.

Hair regeneration refers to generating brand new hair follicles and can be referred to as follicle neogenesis.

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.

Regeneration 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.  Those who have 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.

Cells are then either used to rejuvenate and rebuild existing miniaturising follicles or used 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 follicles that will be used as a source of cells for 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 once step 3) is launched

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

To find out the cost of banking follicles, please contact your nearest HairClone partner clinic. Costs will vary depending on location and whether follicles are taken as part of a hair transplant procedure or as a stand alone procedure.

The cost to bank includes tax, transportation, testing, cryopreservation and the first year’s banking fee.  The surgical cost to extract the follicles is in addition to this and will vary from clinic to clinic.

There will be a subsequent annual fee for us to store the follicles, which will be explained during a consultation with a clinical partner.

We have established a 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.

Q?

What is meant by reprogramming hair follicles?

A.

HairClone’s rejuvenation therapy aims to reprogram hairs that are miniaturising into hairs that are resistant to miniaturisation by replacing lost DP cells within follicles. As hairs miniaturise, DP cells are lost. HairClone’s cell therapy then aims to replace those cells with DP cells that are resistant to further loss. This would lead to long-term results. Treatment would need to be repeated as more of the original DP cells are lost from follicles and require replacement.