Following on from gaining FDA-clearance for its 'STYLE Trial
' investigating a possible liposuction-based treatment for male and female pattern hair loss
, Kerastem Technologies LLC has now released further information about this phase II clinical trial.
The San Diego-based company is funding research into exploring cell-enriched adipose (fat tissue) as another future treatment for androgenetic alopecia
in both men and women. Due to commence in December 2015, will be led by principal investigator Ken Washenik, MD of Bosley Medical/NYU.
The trial is taking place in America as, according to the company's website, Kerastem Hair Therapy is already commercially available in Japan and parts of Europe.
Adipose and hair loss
According to Kerastem, there is an 'emerging relationship' between the body's fat tissue, adipose, and hair. According to a 2012 article in Experimental Dermatology, it is thought to play an important part in the hair growth cycle
and, as such, the company is keen to investigate the potential of using adipose to combat hair loss.
As we previously reported, the clinical trial aims to see how adipose fares against genetic hair loss
in 70 volunteers, when taken via liposuction from participants' hip area then stem-cell enriched, before being injected back into the scalp. The primary aim is to ascertain safety and tolerability information, with the secondary aim being to assess any resultant changes in hair growth and density.
Entitled the 'Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue For Follicular Niche Stimulation in Early Stage Alopecia
Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial', more information about the STYLE trial's methods are now available to view on the clinicaltrials.gov
Requirements for participants
Taking place at eight different centres, male and female trial participants will all fit a list of specified criteria. Men must have male pattern hair loss
measuring Grades III, IIIA, III-Vertex, IV or IV-A, whilst women should have female pattern hair loss
consistent with Grades I-3, I-4, II-1, or II-2 on the on the Norwood and Savin scales
All volunteers have to be at least 18 years of age, weigh no more than 40kg/m2 (this is considered moderately obese on the BMI scale) and women must not be or try to become pregnant for the duration of the study. Both men and women taking part must also agree to 'maintain a consistent hair length and natural hair color, without the use of any coloring agents' during the research period.
Extensive exclusion criteria prevents anyone who has used any form of herbal or pharmaceutical hair loss products
in the past six months, or dutasteride or finasteride 1mg
within 12 months of screening. Those who have a history of illnesses
that can cause hair loss, including autoimmune disease, diabetes, thyroid disorders and those who have previously had no response to hair loss treatments
are also ineligble, as are people who have had a hair transplant
or any other form of scalp surgery.
Anyone who meets the other standards and is already considering elective cosmetic liposuction is also able to be considered for the STYLE trial. This is somewhat surprising given temporary hair loss from a condition called Telogen Effluvium
is possible following surgery. Given this type of liposuction is likely to involve a greater area than that required for other participants, the STYLE trial results may prove incomparable.
Once they have been assessed to ensure they meet the necessary criteria and provided their informed consent, all appropriate matches will take part in screening evaluations and pre-operative testing. After these results have been reviewed the final 70 participants will be chosen.
What the study involves
To start, each participant will undergo liposuction fat harvesting using local anaesthetic, either with or without sedation, to remove the necessary adipose.
Lipoaspirate - the material removed during liposuction - will be processed to remove impurities using a fat grafting and filtration system owned by Kerastem's sister company, Puregraft, then using a Celution System to isolate and concentrate the ADRCs.
Following this they will receive subcutaneous scalp injections featuring one of four solutions which will be assigned at random. Of the 70 volunteers, 20 participants will receive fat graft cells enriched with low dose of adipose-derived regenerative cells (ADRCs), whilst an additional 20 will receive a high dose. A non-enriched fat graft that uses a visually-matched blood saline solution, known as the 'fat alone control' will be given to 20 more participants, and the last option - a control, no-fat saline solution - will be given to the remaining 10 test subjects. Each will be administered in a 2:2:2:1 ratio.
Various methods will be employed to appraise each individual's recorded results from the trial. These include hair growth and hair density assessments by trichogram, photographic assessment and something called a 'Hair Investigator Satisfaction Survey'. This is answered by the physician treating each participant and affords them the opportunity to feedback on their personal observations and assessments.
It will be a while before any results become available as the STYLE trial currently has a final completion date slated for June 2017 although initial primary findings are due to be completed by December 2016. Anyone concerned about thinning hair
would be well-advised not to wait for these findings before seeking help as genetic hair loss is a progressive condition. New treatments can take many years to develop
but, in the meantime, there are clinically-proven hair loss treatments already available. Furthermore, these have been shown to provide significant regrowth
results in both men and women.