A multi-center, open-label, pilot study of allograft adipose matrix for the correction of atrophic temples

Autologous fat grafting (AFG) and synthetic fillers are currently used in esthetic and reconstructive surgery. Challenges in AFG include inconsistent graft retention, donor site morbidities, insufficient harvest, and excessive harvesting times. An allograft adipose matrix (AAM) has been developed as an off-the-shelf alternative to AFG and synthetic fillers.

To evaluate the clinical safety and retention of an AAM over 24 weeks after treatment of bilateral atrophic temples.

Ten subjects (nine females, one male, aged 47-69 years) with temple atrophy were enrolled in the IRB-approved study. AAM (Renuva^® , MTF Biologics, Edison, NJ) was injected (<3 mL) bilaterally into the atrophic temples of each subject. Volume retention, global improvement, and safety were evaluated at 1, 4, 8, 12, 16, 20, and 24 weeks. Biopsy specimens were obtained for adipogenic and angiogenic histological evaluation.

The mean temple volume improved over the baseline and was retained throughout the study period. Fullness (measure of volume) increased immediately from 0 pretreatment to 2.8 post-treatment (scale 0-4 = none-maximum). Fullness varied from 0.8 to 2.2 from weeks 1 through 12 and was 2.7-3.0 from weeks 16-24, around 75% increase from baseline. Furthermore, skin tone, smoothness, texture, and overall appearance also improved with 71% of subjects being satisfied to very satisfied with the results. Adverse events were minimal and histology revealed native tissue incorporation and remodeling.

AAM is safe and well tolerated, provides at least 6-month volume retention, improves skin quality, and supports adipose tissue remodeling after treatment into temples.