Large-Volume Soft Tissue Reconstruction Using Acellular Adipose Tissue
Abstract
Soft tissue loss frequently occurs in the complex traumas suffered by military personnel in training and combat. Such damage is frequently permanent and causes disfiguring depression in skin where volume is lost, which can impact both cosmesis and function. Implants and bone fillers are available for bony reconstruction, but few medical devices are available for reconstruction or augmentation of soft tissue. Even the most inventive reconstructive surgeons using conventional techniques – skin grafts, tissue expansion, local tissue rearrangement, distant pedicle flaps – have disappointing results with poor motor function and unsatisfactory aesthetics. For these reasons, a predictable, “off-the-shelf” material that retains the mechanical and biological properties of adipose tissue would be ideal for the permanent reconstruction of soft tissue defects and soft tissue augmentation. Adipose (fat) tissue is the material of choice in repairing soft tissue defects because of its highly elastic physical properties and tissue bulking capabilities. Unfortunately, today’s fat grafting procedures require harvesting from another part of the body. The harvest procedure is typically performed in the operating room, which requires a complex medical team and time in a high-cost medical environment. Additionally, tissue harvest causes patient morbidity and some patients are not candidates as they may not be healthy enough to tolerate general anesthesia or simply do not have adequate donor tissue for grafting. To address this technology gap, we developed an acellular adipose tissue (AAT) biomaterial product that has similar properties compared to the natural tissue but is off-the-shelf, which allows it to be administered in an out-patient setting with minimal medical personnel and equipment. Preclinical testing of the soft tissue replacement technology in multiple preclinical models demonstrated its capability to physically maintain tissue volume and biologically induce new tissue development. A Phase I safety clinical trial was completed and demonstrated safety of the material. This proposed study, “Large volume soft tissue reconstruction with an acellular adipose product,” is directly responsive to the Fiscal Year 2019 Peer Reviewed Medical Research Program Clinical Trial Award Tissue Regeneration Area of Encouragement. The proposed study is the first to evaluate the efficacy of the AAT technology in reconstructing soft tissue defects, and the resulting technology will be relevant to patients with such defects resulting from trauma or surgery. Results from this study will have critical implications for the technology’s development and its translation towards treating patients. A specific benefit of the proposed technology is its ability to provide an immediate, permanent tissue replacement as new tissue growth is stimulated by the material without the additional risk of anesthesia or the expense associated with the fat-harvesting procedure necessary for fat grafting. Since there is no available technology to fill this need gap, particularly for the larger volumes that the Food and Drug Administration (FDA) is allowing us to test, positive results will provide a paradigm change for patient treatment. The manufacturing advances, transition development, and Phase 2 clinical trial results in the proposed research will accelerate product development. This study leverages the strengths and diverse expertise from our well-established and successful collaborative team to achieve the program goals and advance the AAT technology towards clinical use.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010333
Entities
People
- Jennifer Elisseeff
Organizations
- Johns Hopkins University
- United States Army