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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Aegeria Soft Tissue LLC.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01992315
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aegeria Soft Tissue LLC
  Purpose

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.


Condition Intervention Phase
Disorder of Soft Tissue of Body Wall Region Device: Adipose-derived ECM Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Decellularized Adipose Derived-ECM for the Correction of Acquired Soft Tissue Deformities of the Body and Face

Further study details as provided by Aegeria Soft Tissue LLC:

Primary Outcome Measures:
  • Clinical assessment of toxicity associated with soft tissue injection of Adipose-derived ECM [ Time Frame: 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:
  • Objective assessment of volume retention following soft tissue injection of Adipose-derived ECM [ Time Frame: 6 weeks ]
    At each visit, week 1, 4, and 6, 3-D photography will be performed to assess volume retention


Other Outcome Measures:
  • Measure of physician satisfaction [ Time Frame: 6 weeks ]
    Physician satisfaction will after using the decellularized adipose derived-ECM. This will be performed using a questionnaire to be completed by participating physicians.

  • Measure of participant satisfaction [ Time Frame: 6 weeks ]
    Participant satisfaction measurement will be performed using a survey to completed by participants at each follow up visit, week 1, 4 and 6.


Estimated Enrollment: 12
Study Start Date: March 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adipose-Derived ECM Device: Adipose-derived ECM
Each syringe of adipose-derived ECM will hold 2mL and will be for single use only. Up to 3 syringes (6mL total) may be used for each patient. Injections will be made under local anesthesia and sterile conditions using a 23-gauge needle. All injections will be performed in an outpatient clinic setting at study site by the principal investigator who will determine the method, depth, and volume of each implant. Decellularized adipose tissue-derived matrix will be infiltrated into the defect and the underlying musculature as well as the subcutaneous tissue surrounding the defect, with the goal of creating a smooth transition from surrounding structures to the filled defect. This will be performed using a series of multiple punctures or a single puncture with a fanning or threading technique. After the injection is completed, the treatment area will be massaged to conform to the contour of the surrounding tissue and ice will be applied as needed for swelling.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992315


Contacts
Contact: Nancy Teasley, RN (410) 296-0414 Nancy Teasley <wateas@verizon.net>
Contact: Amit Kochhar, MD 3057101130 akochha4@jhmi.edu

Locations
United States, Maryland
Cosmetic Surgery Center of Maryland Not yet recruiting
Towson, Maryland, United States, 21204
Contact: Nancy Teasley    410-296-0414    Nancy Teasley <wateas@verizon.net>   
Contact: Amit Kochhar, MD    3057101130    akochha4@jhmi.edu   
Principal Investigator: Larry Lickstein, MD         
Sponsors and Collaborators
Aegeria Soft Tissue LLC
Investigators
Principal Investigator: Larry Lickstein, MD Cosmetic Surgery Center of Maryland
  More Information

Additional Information:
Publications:
Responsible Party: Aegeria Soft Tissue LLC
ClinicalTrials.gov Identifier: NCT01992315     History of Changes
Other Study ID Numbers: AST Adipose ECM
First Submitted: November 14, 2013
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Aegeria Soft Tissue LLC:
Scar
Soft tissue defect