Treatment of Androgenic Alopecia with Cell Enriched Follicular Niche Fat Grafting; Results of the STYLE Trial; a Multicenter Randomized Clinical Stud

on

Introduction: Research efforts to understand the pathophysiology of androgenic alopecia have pinpointed key role of adipose cells surrounding the hair bulb, i.e. the follicular niche, in maintenance of a robust hair cycle. Androgenic alopecia is associated with attrition of follicular niche adipose tissue, and in particular the adipose derived regenerative cells, ADRCs. It is hypothesized that replacement of ADRCs in the follicular niche will delay androgenic alopecia and improve terminal hair growth.  

We conducted an IRB approved, randomized, controlled, multicenter clinical study (STYLE) to evaluate the safety and feasibility of autologous fat grafts enriched with ADRCs in the treatment of early alopecia. 

 

Materials & Methods: A total of 71 male and female subjects with early androgenic alopecia (Norwood-Hamilton 3) were randomized to 4 treatment groups:  

1. 16 with Puregraft fat + 1.0 x 106 ADRCs/cm2 scalp;  

2. 22 with Puregraft fat + 0.5 x 106 ADRC/cm2 scalp;  

3. 24 with Puregraft fat alone;  

4. 9 with saline (control group)  

ADRCs were isolated from autologous lipoaspirate and viable cells quantified prior to injection. Fat graft was prepared with the Puregraft system. Treatments were delivered to 40 sq. cm of scalp via two injections; Puregraft prepared fat graft (dose 0.1ml/cm2 scalp was injected in proximity to the follicular niche in the subcutaneous layer and an intradermal injection delivered a prescribed dose of ADRCs. Control subjects received saline only. Endpoint data, terminal hair counts and hair shaft width were obtained from standardized macro and global scalp photos obtained at baseline, 6 and 24 weeks.  

 

Results: A total of 71 subjects, (17 female, 54 male, mean age 41), completed the trial and there were no unanticipated adverse events. A statistically significant increase in terminal hair count (p<0.05) the Puregraft Fat + Low Dose ADRCs group compared to Controls at 24 weeks (mITT; n=22) was found, representing a mean increase of 17 terminal hairs/cm2. This group also showed a trend toward increased hair width (p=0.065) compared to controls. We did not identify a dose response relationship as there was not a statistically significant response in the high dose group.  

  

Conclusions:  The hypothesis that androgenic hair loss can be effectively treated by improving the milieu of the follicular niche is clearly supported by the results of this study. Puregraft fat graft and low dose autologous ADRCs injected for early androgenic hair loss showed a significant increase (p>0.5) in terminal hair counts at 24 weeks. Trending data also suggest improvement in hair width and slowing of hair loss.    

 

Dr Joel Aronowitz

Comments

Post a Comment