Another new clinical trial investigating what may turn out to be the next generation of treatments to combat hair loss
has just been announced.
It is the latest in a run of innovative adipose-related hair loss research
projects whereby body fat, generally for this purpose extracted from the hip area, is modified then injected back into the scalp in order to promote hair growth. It is designed to treat androgenetic alopecia, so both male pattern baldness
and female hair loss
This new trial aims to compare the results of three different types of treatment courses each featuring adipose-based treatments combined with platelet rich plasma therapy (PRP)
- which is also suitable for both sexes - to see which could be most effective in treating genetic hair loss
Comparing adipose-derivatives and PRP formulas
Each participant will have blood drawn, and body fat taken via lipoaspiration (defined as <100 cc); they will then be allocated one of the three treatment options for the duration of the trial. The three different sets of treatments being studied in these Phase 1 and 2 trials are as follows:
1. HD-PRP + Matristem Matrix (ACell)
2. HD-PRP + Emulsified AD-tSVF
3. HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF
PRP is a popular cosmetic treatment though recent research
has shown it to be unsuccessful as a hair loss treatment in its own right. It is generally considered more of a booster when used alongside medically-proven pharmaceutical hair loss treatments
. In all instances 'HD' stands for 'high density'.
Whilst hair loss injections using PRP and Acell
- as per the first set of treatments outlined -
have previously been tested, the interventions outlined in points 2 and 3 are both experimental.
The second treatment will therefore involve high density PRP being blended with AD-tSVF, an emulsified adipose-derived tissue stromal vascular fraction, and applied to the scalp via injection. The third treatment will build on the exact same formula as the second but will add in another component - cell-enriched AD-cSVF, a fluid of enriched adipose stem/stromal cell-enriched concentration of stromal/stem cells, produced using novel Healeon technology - to the biocellular mixture.
According to the research submisssion, 'Successful stem/stromal cell-enrichment of AD-tSVF and HD PRP biocellular mixture has been reported in numerous peer-reviewed and published clinical experiences of injections for structural tissue augmentation in plastic surgery, chronic wound therapies, and ultrasound guided musculoskeletal treatments in orthopedic surgery. A "retrograde" filling technique creating a potential space and subsequently injecting into this space the biocellular material as the needle is withdrawn is advanced in this study.'
The primary aim of this study is to clarify the safety and tolerability of using each set of treatment to address androgenetic alopecia in men and women with mild to moderate hairloss. In addition to this the team will also study changes in hair growth, hair density and patient satisfaction.
Findings due 2018
The study has been registered at clinicaltrials.gov
under its official title: Biocellular Regenerative Therapy in Hair Loss
: Use of High Density Platelet-Rich Plasma Concentrates and Cell-Enriched Emulsified Adipose-Derived Tissue Stromal Vascular Fraction.
Investigators from Regeneris, Northwest Hair Restoration and the Hair Transplant Institute of Miami will run this study from August 2016 in conjunction with Healeon Medical Inc and the Ministry of Health, Honduras, and an estimated completion date of March 2018 has been set.
It is hoped that the primary findings from this study will be released some time after this once the data has been collected and analysed, so we hope to bring you an update as soon as this information becomes available.
For those experiencing excessive shedding now, having the possibility of information regarding a new treatment in 2018 - not even a potential release date that this treatment could be made available to the public should it pass the necessary safety and efficacy tests - is of little to no help. Luckily, however, for those for whom thinning hair
is a troubling concern, there are already medically-proven hair loss treatments available, and a consultation with a hair specialist can help to determine the most suitable options.