Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 351

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 351
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 not note any unexplained changes
in patient laboratory values during the study that were likely related to the study intervention. All participants were healthy and well-appearing
at study visits. All physical examinations were unremarkable for every subject throughout the study, with one exception: Participant #01
experienced a serious adverse event following implant excision that was determined by the medical monitor not to be related to the AAT.
All eight subjects had at least one anticipated adverse event (“AE”) that was considered related to a study implant; however,
these anticipated AEs were mild and localized to AAT injection sites. Anticipated AEs experienced by patients included pain/tenderness
(n=2 participants), erythema (n=4), bruising (n=4), hyperpigmentation (n=1), and textural change (n=3). No subject experienced abrasion,
edema, blistering, blanching, crusting, oozing, purpura, scabbing, ulcer, or scarring at their injection site(s), all of which are other
common AEs associated with injections.

Cellular migration
from the host tissue into the implant was apparent at the host-implant boundary and increased with duration of implantation. After 18
weeks in situ, there were more cells present at the implant periphery and implant center compared to earlier time points. Multispectral
immunohistochemistry (“IHC”) also revealed the formation of new blood vessels at the edge of the implant (CD31
vascular endothelial cells) and infiltration of perivascular/adipose stem cells (CD34) both around and within the implant
at 18 weeks post-injection. By this latest excision time point, CD4 T cells dominated within the scaffold-recruited T cell
population. Though both CD4 and CD8 T cells were found dispersed individually throughout the implant, they also
often formed clusters with other non-T immune cells which resembled small tertiary lymphoid structures.

Subcutaneous
injection of AAT in healthy volunteers. (A) H&E staining of AAT implants excised from healthy volunteers at early, mid and late time-points
during a first-in-human Phase 1 study. High magnification insets show cell migration from the adjacent host tissue into the AAT matrix.
(B) Multispectral immunohistochemistry (IHC) reveals formation of blood vessels (CD31) and migration of adipose stem cells
(CD34).

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