Clinical trial NCT01992315: Investigation of A-ECM for the Correction of Soft Tissue Defects
Official title: Investigation of Decellularized Adipose Derived-ECM for the Correction of Acquired Soft Tissue Deformities of the Body and Face
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Disorder of Soft Tissue of Body Wall Region
Keywords: Scar
Soft tissue defect
Lead sponsor: Aegeria Soft Tissue LLC
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical assessment of toxicity associated with soft tissue injection of Adipose-derived ECM
timeFrame: 6 weeks
Secondary outcomes:
measure: Objective assessment of volume retention following soft tissue injection of Adipose-derived ECM
timeFrame: 6 weeks
Other outcomes:
measure: Measure of physician satisfaction
timeFrame: 6 weeks
measure: Measure of participant satisfaction
timeFrame: 6 weeks
Locations:
city: Towson
country: United States
facility: Cosmetic Surgery Center of Maryland
state: Maryland
Study officials:
affiliation: Cosmetic Surgery Center of Maryland
name: Larry Lickstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu I, Nahas Z, Kimmerling KA, Rosson GD, Elisseeff JH. An injectable adipose matrix for soft-tissue reconstruction. Plast Reconstr Surg. 2012 Jun;129(6):1247-1257. doi: 10.1097/PRS.0b013e31824ec3dc.