Safety Study of Acellular Adipose Tissue for Soft Tissue Reconstruction

NCT02817984 | Completed Phase 1

• 3 other identifiers: IRB00027657CF-1116520
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and tolerability of acellular adipose tissue (AAT), intended for the repair of soft tissue defects in humans, in healthy volunteers. The investigators hypothesize that AAT will be safe and well tolerated upon injection into human soft tissue.

Conditions

Healthy Volunteers

Keywords

Abdominoplasty

Outcome Measures

Primary Outcomes (2)

• Safety of acellular adipose tissue (AAT) injections as determined by the incidence of adverse events

  Up to 12 weeks post-injection

• Safety of acellular adipose tissue (AAT) injections as determined by the rate of adverse events

  Up to 12 weeks post-injection

Secondary Outcomes (3)

• Assess the histopathology of explanted implants via Hematoxylin and eosin (H&E) staining

  Up to 12 weeks post-injection

• Assess the histopathology of explanted implants via flow cytometry

  Up to 12 weeks post-injection

• Assess tolerability of AAT injections per the participant-reported experience.

  Up to 12 weeks post-injection

Other Outcomes (1)

• Assess tolerability of AAT injections per the physician-reported experience.

  Up to 12 weeks post-injection

Study Arms (1)

Treatment Group

EXPERIMENTAL

Participants (n=10) will be enrolled and assigned chronologically to one of five excision time points: Weeks 2 (n=10), 4 (n=2), 6 (n=2), 8 (n=2), and 12 (n=2) post-injection. Implants will be injected on Day 0. All participants will be administered up to five (5) 2 milliliter (mL) subcutaneous injections of acellular adipose tissue (AAT) via sterile injection into the area identified for planned excision. Total injected AAT volume per patient will not exceed 10 mL.

Biological: Acellular Adipose Tissue (AAT)

Interventions

Acellular Adipose Tissue (AAT) BIOLOGICAL

The components of the adipose-derived scaffold are all naturally occurring AAT proteins and proteoglycans that provide a natural scaffold. The nature of the AAT also enhances host tissue integration since matrix components can be easily degraded by cell-secreted enzymes as tissue remodeling takes place. Mechanisms for matrix turnover are already established in host cells, avoiding any concerns over proper clearance of scaffold materials from the body.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women aged 18-65 years who have sought elective surgery for the removal of redundant tissue of the abdomen (abdominoplasty or panniculectomy) or arm (brachioplasty).
• Willingness to delay elective surgery up to 12 weeks in order to participate in the study.
• Consent to photography for research purposes.
• Willingness to follow study requirements.
• Ability to give informed consent.
• Participants must be willing to perform follow up visits for up to 5 months.
• Undergo complete blood count (CBC) with Differential and Serum Chemistry. (Results must fall within 1.5 times the normal ranges for all values for candidates to be eligible.)
• Men and Women of reproductive potential: Willingness to use approved methods of birth control or abstain from sexual intercourse from screening until removal of the AAT implants.
• Definition of non-childbearing potential for Women: amenorrhea (previous 12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• Definition of non-reproductive potential for Men: confirmed surgically sterile (vasectomy \>3 months prior to screening).

You may not qualify if:

• Patients seeking elective surgery for the removal of redundant tissue from areas other than the abdomen or arm.
• Use of AAT in patients exhibiting autoimmune connective tissue disease is not recommended. When applied properly, AAT has been shown to support the migration of host cells from the surrounding tissue. Therefore, this study will exclude patients with conditions that could inhibit migration of host cells including, but not limited to, the following:
• Fever (oral temperature \>99º F at time of screening)
• Insulin dependent diabetes
• Low vascularity of the tissue intended for elective excision
• Local or Systemic Infection
• Mechanical Trauma
• Poor nutrition or general medical condition
• Dehiscence and/or necrosis due to poor revascularization
• Specific or nonspecific immune response to some component of the AAT material
• Infected or nonvascular surgical sites
• Known cancer or receiving treatment for cancer
• Pregnant or Lactating females
• Inability to cooperate with and/or comprehend post-operative instructions
• Inability to speak or read English

Sponsors & Collaborators

• Johns Hopkins University: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 22327888 BACKGROUND

Study Officials

• Jennifer H Elisseeff, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 29, 2016
• Study Start: April 1, 2016
• Primary Completion: April 6, 2017
• Study Completion: April 6, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)