Disorder of Soft Tissue of Body Wall Region Clinical Trial
Official title:
Investigation of Decellularized Adipose Derived-ECM for the Correction of Acquired Soft Tissue Deformities of the Body and Face
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.
| Status | Not yet recruiting |
| Enrollment | 12 |
| Est. completion date | August 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 50 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Cosmetic Surgery Center of Maryland | Towson | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Aegeria Soft Tissue LLC |
United States,
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):1247-57. doi: 10.1097/PRS.0b013e31824ec3dc. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Measure of physician satisfaction | Physician satisfaction will after using the decellularized adipose derived-ECM. This will be performed using a questionnaire to be completed by participating physicians. | 6 weeks | No |
| Other | Measure of participant satisfaction | Participant satisfaction measurement will be performed using a survey to completed by participants at each follow up visit, week 1, 4 and 6. | 6 weeks | No |
| Primary | Clinical assessment of toxicity associated with soft tissue injection of Adipose-derived ECM | 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 | 6 weeks | Yes |
| Secondary | Objective assessment of volume retention following soft tissue injection of Adipose-derived ECM | At each visit, week 1, 4, and 6, 3-D photography will be performed to assess volume retention | 6 weeks | No |