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A Novel Injectable Composite Collagen Hydrogel That Induces Long Lasting New Tissue Formation
Xue Dong, MD, PhD1, Derek Luong, PhD
2, Adam Weisel, BSE
2, Rachael Cohen, BS
2, Jonathan Yao, MD
3, Yulia Sapir-Lekhovitser, PhD
2, Jason A. Spector, MD
1.
1Weill Cornell Medical College, New York, NY, USA,
2FesariusTherapeutics, Inc, New York, NY, USA,
3NA, NA, NY, USA.
Although hyaluronic acid is the dominant filler used for facial restoration, its volumizing effect is only temporary because it does not induce new tissue formation. Pre-clinical porcine excisional wound studies using composite collagen hydrogels (CCH), composed of high-density collagen microspheres within a low-density collagen matrix, demonstrated enhanced cellular infiltration, vascularization and robust new collagen deposition when applied as a sheet gel. Herein we evaluate an injectable form of the CCH for use as a soft tissue filler.
Sterile 1% bovine atelocollagen microspheres (80-300um tin diameter) were mixed with 0.3% telocollagen bulk at different microsphere-to-bulk ratios (70:30, 50:50, 30:70) to fabricate a homogeneous viscous solution for injection. 500ul of each CCH was injected subcutaneously into wildtype mice and subsequently volume retention and histological analysis was performed.
The CCH flowed easily for injection. After 6 months
in vivo, the shape of the injected material was well-maintained, and the 70:30 CCH group retained nearly 90% of the injected volume. Histologic analysis demonstrated a uniform distribution of collagen microspheres, with significant cell infiltration and vascularization observed within the bulk collagen after only 1 month. Host collagen deposition and maturation increased over time, with pronounced vessel formation, particularly in the 70:30 group. Macrophage infiltration decreased significantly over time, indicating minimal inflammation and no adverse foreign body reaction or chronic inflammation was observed.
This unique CCH enhances neovascularization and promotes new host collagen deposition, resulting in excellent retention of volume and projection. Ongoing longer term studies will verify the permanence of the newly deposited tissue.
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