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

NCT ID: NCT01992315

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-08-31

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.

Conditions

Disorder of Soft Tissue of Body Wall Region

Keywords

Scar; Soft tissue defect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adipose-Derived ECM

Group Type: EXPERIMENTAL

Adipose-derived ECM

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aegeria Soft Tissue LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry Lickstein, MD

Role: PRINCIPAL_INVESTIGATOR

Cosmetic Surgery Center of Maryland

Locations

Cosmetic Surgery Center of Maryland

Towson, Maryland, United States

Countries

United States

Central Contacts

Nancy Teasley, RN

Role: CONTACT

Phone: (410) 296-0414

Email: Nancy Teasley <wateas@verizon.net>

Amit Kochhar, MD

Role: CONTACT

Phone: 3057101130

Email: akochha4@jhmi.edu

Facility Contacts

Nancy Teasley

Role: primary

Amit Kochhar, MD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 22327888 (View on PubMed)

Other Identifiers

AST Adipose ECM

Identifier Type: -

Identifier Source: org_study_id