Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 348

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 348
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s, cells were resuspended
in AAT immediately prior to injection. No volume loss was observed in AAT without ASCs over 12 weeks (final average volume ratio of 1.08),
while inclusion of ASCs in the scaffold resulted in gradual loss of volume over the study period (final volume ratio of 0.63). We also
compared AAT with lipoaspirate (also known as fat grafting) as the gold standard treatment for soft tissue volume correction. AAT and
fat grafts were placed at distal sites on the same mice (n = 6) and exhibited similar loss of volume (final volume ratios of 0.59 and
0.53 for AAT and fat grafting, respectively). AAT implants lost volume faster in this study where the athymic mice also received fat grafts.
AAT implants in fat-grafted animals also demonstrated increased cellular infiltration compared to AAT implanted in animals that only received
the scaffold injections. Hematoxylin and eosin (“H&E”) staining of AAT showed extensive de novoadipose tissue
formation and collagen remodeling where ASCs had been delivered with the scaffold. In these implants, much of the AAT was replaced by
new adipose tissue. The implant edges appeared completely populated by adipocytes while the center of the AAT had less adipogenesis and
regions where the implant was still visible suggesting progressive inward cell migration and differentiation.

While the AAT
and fat grafts exhibited similar volume retention, gross and histological examination of the explanted AAT, AAT with ASCs, and fat grafts
at 12 weeks revealed significant differences in cellular reactions at the implant site. Each type of recovered implant had a distinct
gross morphology. Fat grafts retained the distinct yellow color characteristic of the intracellular lipids found in native human adipose
tissue. AAT implants without ASCs retained the white color of the AAT material, while AAT with ASCs took on the color and texture of the
surrounding tissues. The edge and center of AAT implants were well- infiltrated with host cells, with clusters of adipocytes present near
the implant edges and small caliber blood vessels present both peripherally and in the center of implants. In contrast, the fat grafts
had only a layer of viable adipocytes on the outside layer of the implants with large necrotic cysts towards the center of the implant.
Regions of calcification surrounded by ph