Investigation of A-ECM for the Correction of Soft Tissue Defects

Status unconfirmed · Phase 1

Conditions studied: Disorder of Soft Tissue of Body Wall Region

In brief

Soft tissue injury leads to significant deformity in size, shape and body contour. Adipose tissue, continues to be the tissue of choice in repairing soft tissue defects due to traumatic or other defects. Current autologous fat transfer techniques, however, have a number of limitations including significant donor site morbidity, unpredictable resorption, and the potential for requiring revision. Thus, an "off-the-shelf" material that retains the mechanical and biological properties of adipose tissue would be ideal for the reconstruction. Extracellular matrix (ECM)-based biomaterials have the potential to be a non-immunogenic biological scaffold for adipose tissue engineering for repair of soft tissue defects. Our collaborators have recently generated a novel tissue-derived material to improve soft tissue reconstruction. The final, processed adipose tissue does not contain cellular components, yet retains the native architecture and bioactivity of the original adipose tissue. The tissue is then further processed into particles to create an injectable implant. In preclinical models, we have demonstrated that human adipose tissue can be decellularized by mechanical processing with preservation of matrix ultrastructure. Histologic analysis two-weeks after implantation into rats showed minimal inflammatory reaction and good tissue integration of the decellularized, dilipidized, adipose derived-ECM. The goal of the study is to 1) evaluate the safety and compatibility of the soft tissue implant, and 2) determine the efficacy of this ECM replacement in soft tissue injuries after 6 weeks. Specifically, the volume of the soft tissue defect will be determined before implantation and at multiple time points over the following 6 weeks. We hypothesize that the decellularized adipose ECM will retain at least 50% volume and surface area after 6 weeks. If our results are promising, decellularized adipose derived-ECM may be a viable alternative to autologous tissue transplantation for correction of soft tissue deformity.

Key facts

Study ID

NCT01992315

Run by

Aegeria Soft Tissue LLC

People needed

12

Starts

2014-03-01

Expected to finish

2015-08-01

Last updated by the study team

2013-11-25

Who can join

Age: 20 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women, ages 20-50, with previous congenital or acquired soft tissue deformities of the body or face that are willing to have photographs taken may join this study

You may not qualify if…

• pregnant women, patients with known immunocompromise or wound healing disorders

Where it is running

• Cosmetic Surgery Center of Maryland — Towson, Maryland, United States

Full record on ClinicalTrials.gov

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