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

Phase 1

• Conditions: Disorder of Soft Tissue of Body Wall Region
• Interventions: Device: Adipose-derived ECM

• Registration Number: NCT01992315
• Lead Sponsor: Aegeria Soft Tissue LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-19
• Last Update Submitted: 2013-11-19
• Study First Posted: 2013-11-25
• Last Update Posted: 2013-11-25
• Study Start: 2014-03
• Primary Completion: 2015-06
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adipose-Derived ECM	Adipose-derived ECM	-

Primary Outcome Measures

Name	Time	Method
Clinical assessment of toxicity associated with soft tissue injection of Adipose-derived ECM	6 weeks	At each post-injection visit, week 1, 4, and 6, the principal investigator will examine patients for presence of adverse events such as toxicity, pain/inflammation at the site of injection

Secondary Outcome Measures

Name	Time	Method
Objective assessment of volume retention following soft tissue injection of Adipose-derived ECM	6 weeks	At each visit, week 1, 4, and 6, 3-D photography will be performed to assess volume retention

Trial Locations

Locations (1)

Cosmetic Surgery Center of Maryland; 🇺🇸 Towson, Maryland, United States