Clinical Evaluation of an Off-the-Shelf Allogeneic Adipose Matrix for Soft Tissue Reconstruction

Abstract

Background: Biomaterials derived from human adipose extracellular matrix have shown promise in vitro and in animal studies as an off-the-shelf adipogenic matrix for sustained volume replacement. Herein, we report the results of a randomized prospective study conducted with allograft adipose matrix (AAM) grafted into the pannus of presurgical abdominoplasty patients 3 or 6 months before scheduled surgery. This is the first report of a longitudinal histologic analysis of AAM in clinical use. Methods: Ten healthy patients undergoing elective abdominoplasty were recruited to receive AAM before surgery. Enrolled subjects were randomized into either a 3-month follow-up cohort or a 6-month follow-up cohort. Subjects were monitored for adverse events associated with AAM grafting in addition to undergoing serial biopsy. Following surgical excision of the pannus, representative samples from the AAM surgical sites were stained and evaluated with hematoxylin and eosin for tissue morphology, Masson’s trichrome for collagen, and perilipin for adipocytes. Results: All subjects tolerated AAM with no severe adverse events reported. At 3 months following implantation, AAM remained visible within the confines of the subjects’ native surrounding adipose tissue with sparse adipocytes apparent within the matrix. By 6 months, AAM had remodeled and was primarily composed of perilipin-positive adipocytes. Histologic analysis confirmed tissue remodeling (hematoxylin and eosin), adipogenesis (perilipin), and angiogenesis (Masson’s trichrome) occurred with the presence of AAM. Conclusions: AAM is a safe, allogeneic, off-the-shelf regenerative matrix that is adipogenic and noninflammatory and promotes angiogenesis.

Clinical Translational Potential in Skin Wound Regeneration for Adipose-Derived, Blood-Derived, and Cellulose Materials: Cells, Exosomes, and Hydrogels

“…Furthermore, the scaffolds were maintained safely for up to 4 months without evidence of complications when implanted subcutaneously under the dorsal skin of the wrist in human subjects, with a single patient showing safety and efficacy after 16 months of implantation [ 82 ]. In an elegant randomized follow-up study, Kokai et al (2020) implanted their adipose-derived ECM product by injection into the pannus of patients scheduled for elective abdominoplasty [ 88 ]. Subsequent analysis of the resected tissues after 3 or 6 months demonstrated safety and efficacy, with histological evidence of remodeling at 3 months and adipogenic differentiation of host ASCs by the 6-month time point [ 88 ].…”

“…In an elegant randomized follow-up study, Kokai et al (2020) implanted their adipose-derived ECM product by injection into the pannus of patients scheduled for elective abdominoplasty [ 88 ]. Subsequent analysis of the resected tissues after 3 or 6 months demonstrated safety and efficacy, with histological evidence of remodeling at 3 months and adipogenic differentiation of host ASCs by the 6-month time point [ 88 ]. These analyses lay the foundation for regulatory approval of the decellularized adipose tissue products for soft tissue regeneration.…”

The role of a shelf‐ready, human‐derived, soft tissue injectable adipose matrix for facial volume correction

“…6,18,25 The main techniques for harvesting of autologous fat for facial volume correction are vacuum aspiration, syringe aspiration, and surgical excision. 26 There is an ongoing debate in the literature as to which method of harvesting produces more viable and functional adipocytes. [6][7][8][9][10] Experimental as well as some clinical studies support direct fat excision over aspiration.…”

“…Its application in the face is particularly interesting because it allows for precise titration and injection 6,18,25 . The main techniques for harvesting of autologous fat for facial volume correction are vacuum aspiration, syringe aspiration, and surgical excision 26 . There is an ongoing debate in the literature as to which method of harvesting produces more viable and functional adipocytes 6‐10 .…”

“…Ten healthy patients undergoing elective abdominoplasty received AAM into the pannus before surgery 26 . The patients were randomized to a 3‐month follow‐up or a 6‐month follow‐up group.…”